AKS) interest in Double Eagle Steel Coating Company by 24hGold 24hgold "/> AKS) interest in Double Eagle Steel Coating Company "/>

United States Steel Corporation

Published : June 01st, 2015

8:35 am U.S. Steel announces the completion of its purchase, of AK Steel's (AKS) interest in Double Eagle Steel Coating Company

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8:35 am U.S. Steel announces the completion of its purchase, of AK Steel's (AKS) interest in Double Eagle Steel Coating Company

2:31 pm Comtech Telecom announces the award of a $2.4 mln contract for high-power solid-state amplifiers and a $1.1 mln contract for new super-power traveling wave tubes (CMTL) : Co announced today that its Santa Clara, California-based subsidiary, Comtech Xicom Technology, received orders totaling $2.4 million to supply X-band solid-state, high-power amplifiers. The amplifiers will be used in small, transportable, military tactical SATCOM terminals that support broadband communications over the Wideband Global SATCOM system. Co also received an order from a domestic integrator for $1.1 million for its new, Super-Power Traveling Wave Tube Amplifiers. 

2:24 pm Shutterfly urges stockholders to vote for its White proxy card, highlighting a release by the proxy advisory firm ISS (SFLY) : Co stated: "While we are pleased ISS recognizes that replacing 33% of the Shutterfly Board with Marathon Partners' nominees is NOT in the best interest of stockholders, we believe ISS reached the wrong conclusion in failing to recommend that stockholders vote "FOR ALL" of Shutterfly's nominees. The Shutterfly Board recommends that stockholders vote "for all" of Shutterfly's director nominees: Jeffrey T. Housenbold, Stephen J. Killeen and James N. White."

2:21 pm SPX back on session highs here moving through afternoon trading with the index now @ 2117.49 +10.10 (SPY) :  

2:21 pm Karyopharm Therapeutics announces clinical data for Selinexor in patients with recurrent glioblastoma and advanced sarcomas (KPTI) : In an ongoing Phase 2 clinical trial, single-agent oral selinexor demonstrated anti-tumor activity in patients with recurrent glioblastoma, including brain penetration at clinically relevant drug levels, with a 13% overall response rate and a 38% disease control rate.

  • In an ongoing Phase 1b clinical study of single agent oral selinexor in patients with advanced sarcomas including liposarcoma, durable activity, including longer progression free survival than last prior regimen, was demonstrated. 
  • Data from an ongoing Phase 2 study of single-agent selinexor in patients with glioblastoma recurred after temozolomide and radiation therapy, including brain penetration at clinically relevant levels, leading to durable anti-cancer activity and disease control of up to 6 months. 
  • Selinexor dosed twice weekly at 50 mg/m2 demonstrated anti-tumor activity with 13% ORR and 38% DCR in 16 surgically ineligible patients with glioblastoma that had been pretreated with temozolomide and radiation.

2:01 pm Index Changes Reminder: Talen Energy (:TLN) will replace Windstream (WIN) in the S&P MidCap 400 after the close of trading (:INDXCH) :  

1:36 pm Global Net Lease confirms its shares will list on the NYSE starting tomorrow (:GNL) : Also, as previously announced, GNL intends to launch a tender offer in conjunction with the listing to purchase up to $125 million of its shares of common stock at $10.50 per share.

1:34 pm S&P 500 sector leadership now seen in Discretionary- XLY, Tech.- XLK, Pharma- XLV, & Industrials- XLI with the index back near the session highs here in recent midday trading (SPY) :

  • SPX @ 2116.28 +8.89

1:21 pm General Electric announces the beginning of new national contract talks with the International Union of Electronic Workers/Communications Workers of America (GE) : GE holds separate talks with each union, and the current four-year contracts with the unions expire at midnight on June 21, 2015. There are ~16,500 GE employees represented by contracts with 11 unions that are part of the Coordinated Bargaining Committee (CBC.V) of GE unions

1:18 pm Canadian Natl Rail announces a C$20 mln investment to expand its cold supply chain capacity, through the acquisition of 200 domestic, 53-foot temperature-controlled containers (CNI) :  

1:17 pm Notable movers of interest (:SCANX) : The following are some of today's most notable movers of interest, categorized by market capitalization (large cap over $10 billion and mid cap between $2-10 billion) and ranked by % change (all stocks over 100K average daily volume). 

Large Cap Gainers

  • ALTR (51.81 +6.06%): Finally confirmed reports it would be acquired by Intel (INTC) for $54/share, or ~$16.7 bln.
  • BMY (66.97 +3.67%): Rebounding from Friday's steep decline on the heels of further updated trials results; co also announced FDA acceptance of the BLA for Opdivo +Yervoy regimen, in patients with previously untreated advanced melanoma.
  • LNKD (201.95 +3.6%): Outperforming following renewed activist chatter.
Large Cap Losers
  • JNPR (26.97 -2.99%): Downgraded to Sell from Neutral at MKM Partners; tgt $22.
  • BRCM (55.77 -1.9%): Pulling back following confirmation of Intel (INTC)/Altera (ALTR) deal; some had speculated Intel may offer a competing bid for Broadcom following last week's announcement it would be acquired by Avago Tech (AVGO).
  • MGM (19.63 -2.09%): Casino names underperforming following data out of Macau that gross gaming revenues fell 37% y/y.
Mid Cap Gainers
  • SINA (50.69 +24.45%): Announced an agreement with its Chairman and CEO for a $456 mln investment in the form of newly issued shares.
  • GPRO (58.44 +5.37%): Announced the availability of its new HERO+ LCD camera, which features a touch screen display.
  • SF (54.86 +3%): Reports out it is in talks to purchase Barclay's (BCS) wealth management division.
Mid Cap Losers
  • ENBL (16.8 -5.62%): Announced that Lynn Bourdon has submitted his resignation and stepped down from his positions as President and CEO.
  • SHAK (78.89 -4.73%): Continued weakness following an additional cautious mention on Mad Money; shares down 18% since 5/22.
  • BBRY (9.48 -3.27%): Announced a settlement with Typo to resolve their outstanding litigation.

1:16 pm Exxon Mobil: The Alaska LNG Project LLC announces US Dept. of Energy conditional authorization, to export liquefied natural gas to non-free trade agreement countries. (XOM) : The application to export up to 20 million metric tons per year of liquefied natural gas from Alaska for a 30-year period was submitted to the U.S. Department of Energy last July. The proposed project facilities include a liquefaction facility in the Nikiski area on the Kenai Peninsula, an 800-mile large diameter pipeline, up to eight compression stations, at least five take-off points for in-state gas delivery, a gas treatment plant located on the North Slope and transmission lines to transport gas from Prudhoe Bay and Point Thomson to the gas treatment plant. The Alaska LNG project participants are the Alaska Gasline Development Corporation (:AGDC) and affiliates of ExxonMobil, TransCanada (TRP), BP and ConocoPhillips (COP)

12:54 pm Midday Market Summary: Influential Sectors Lead at Midday (:WRAPX) : The major averages hold midday gains with the Russell 2000 (+0.6%) and Nasdaq Composite (+0.4%) trading ahead of the S&P 500 (+0.3%).

Prior to the open, index futures spiked to highs following rumors that a deal between Greece and its creditors will be announced today. That rumor was struck down within 15 minutes of making the rounds, but equity futures did not retrace that morning spike until the cash market opened for action.

The stock market spent the bulk of the morning near the unchanged level, but the key indices have returned to their opening highs not long ago with influential sectors powering the move. The top-weighted technology sector (+0.5%) is among the leaders with large cap names like Apple (AAPL 130.93, +0.65) and Microsoft (MSFT 47.43, +0.57) holding gains. Also of note, Altera (ALTR 51.82, +2.97) has surged 6.1% after agreeing to be acquired by Intel (INTC 33.99, -0.47) for $54/share in an all-cash transaction valued at about $16.70 billion.

Elsewhere, the health care sector (+0.5%) has also displayed relative strength even though biotechnology has struggled to keep pace with iShares Nasdaq Biotechnology ETF (IBB 365.48, +0.45) trading higher by 0.1%.

Similar to technology and health care, six other sectors hold midday gains while energy (-0.4%) and telecom services (-0.4%) hover in the red.

Treasuries spent the night near their flat lines, but a daylong retreat has the 10-yr note sitting on its low with the benchmark yield higher by five basis points at 2.17%.

Economic data included Personal Income/Spending data, Core PCE Prices, Construction Spending, and the ISM Index:

  • Personal income increased 0.4% in April after being flat in March while the Briefing.com Consensus expected an increase of 0.3% 
    • According to the wage data from the April employment report, aggregate earnings increased roughly 0.3%, which translated into a 0.2% increase in total employee compensation 
    • Personal spending was flat in April after increasing an upwardly revised 0.5% (from 0.4%) in March while the consensus expected an increase of 0.2% 
    • Core PCE prices rose 0.1% while the Briefing.com consensus expected a reading of 0.2% 
  • Construction spending increased 2.2% in April after increasing an upwardly revised 0.5% (from -0.6%) in March while the Briefing.com consensus expected an increase of 0.8% 
    • That was the largest monthly increase in construction spending since a similar gain in May 2012 
  • The ISM Manufacturing Index increased to 52.8 in May from 51.5 in April while the consensus expected an increase to 51.9 
    • Despite poor regional manufacturing reports, the national index showed a fairly well rounded acceleration in manufacturing activities

12:30 pm Curtiss-Wright says it has sold substantially all of the assets and liabilities of its downstream oil and gas businesses; no terms disclosed (CW) :  

12:28 pm CHS Inc. has acquired the Patriot Renewable Fuels ethanol plant from Patriot Holdings; terms not disclosed (CHSCP) : The Annawan facility produces 125 million gallons of ethanol annually, and is the second ethanol plant that CHS has purchased.

12:28 pm Interactive Brokers reports brokerage metrics for May 2015: Daily Average Revenue Trades rose 19% from prior year 617k (IBKR) : Co reported its Electronic Brokerage monthly performance metrics for May. Highlights for the month included:

  • 617 thousand Daily Average Revenue Trades (DARTs), 19% higher than prior year and 2% lower than prior month. 
  • Ending client equity of $66.7 billion, 31% higher than prior year and 2% higher than prior month. 
  • Ending client margin loan balances of $19.3 billion, 30% higher than prior year and 3% higher than prior month. 
  • Ending client credit balances of $33.8 billion, 22% higher than prior year and 1% higher than prior month. 
  • 306 thousand client accounts, 18% higher than prior year and 1% higher than prior month. 
  • 468 annualized average cleared DARTs per client account. 
  • Average commission per cleared client order of $4.27 including exchange, clearing and regulatory fees.

12:28 pm Market View: SPY, QQQ, DIA, & IWM all move to bounce highs in recent midday trading with SPX now seen @ 2114.63 +7.24 (:TECHX) :  

12:20 pm Spanish Brdcsting announces dismissal of Counts I, II and IV of a lawsuit brought by certain preferred stockholders (SBSA) : Co announced the dismissal of Counts I, II and IV of a lawsuit brought by certain preferred stockholders, which alleged that SBSA had violated the Series B Preferred Stock Certificate of Designations by incurring debt.

  • The lawsuit was filed in the Delaware Court of Chancery on December 27, 2013. Among other things, the lawsuit alleged that non-payment of certain dividends caused a Voting Rights Triggering Event under the certificate of designations for the Series B Preferred Stock, and alleged that the Company was therefore prohibited from incurring indebtedness.
  • On May 19, 2015, the Court of Chancery issued a letter opinion granting SBS's motion to dismiss Counts I, II and IV of the lawsuit. The dismissal was formalized in an order issued by the Court on May 22, 2015. Only Count III of the lawsuit, relating to the Company's October 2013 Series B Preferred Stock repurchase, remains outstanding.

12:17 pm Walt Disney: James Rasulo to step down as CFO of The Walt Disney Company (DIS) : James Rasulo will step down as chief financial officer of The Walt Disney Company (DIS) effective June 30, 2015.

  • Afterward, Mr. Rasulo will continue to serve in an advisory capacity to Mr. Iger and to assist in the transition. A new chief financial officer will be named at a later date.

12:00 pm Essendant shares +4.3% on first day trading after name and ticker change; Formerly was United Stationers (USTR) (:ESND) :  

11:53 am European Markets Closing Prices (:SUMRX) : European markets are now closed; stock markets across Europe performed as follows:

  • UK's FTSE:-0.4%
  • Germany's DAX:+0.2%
  • France's CAC:+0.4%
  • Spain's IBEX:+0.2%
  • Portugal's PSI:0.0%
  • Italy's MIB Index:-0.3%
  • Irish Ovrl Index:June Bank Holiday -- Closed
  • Greece ASE General Index: Whit Holiday -- Closed

11:52 am Market View: Telecom- IYZ -0.90% & Materials- XLB -0.50% the weakest SPX large-cap sector ETFs approaching midday here with SPX now @ 2107.53 +0.16 (:TECHX) :  

11:49 am Stocks/ETFs that traded to new 52 week highs/lows this session - New highs (124) outpacing new lows (110) (:SCANX) : Stocks that traded to 52 week highs: ABCD, ADXS, AEC, AFSI, AGEN, ALN, ALTR, AMAG, AMCN, AMED, AOS, APTS, ATRC, AVGO, BCV, BFAM, BOOT, BSTC, CAPX, CBIN, CBPO, CBS.A, CE, CHE, CIVI, CLCD, CNC, COHU, COKE, CORI, CPK, CSGS, CVBF, DRC, DXPS, EBAY, EBS, EGRX, EMKR, EPAM, EQIX, ERN, FEYE, FNFV, FONE, FSI, FSL, FTAI, GLOB, GSBD, GTN, HALO, HOLX, HRTX, HSP, IACI, IDCC, IMGN, INCY, INFN, INNL, ISSI, IVC, LYTS, MDLZ, MFG, MKSI, MLVF, MMI, MNTA, MSBF, NEP, NPTN, NVEE, NVMI, NXPI, NYCB, OMCL, OMG, ON, ONTY, OPK, PANW, PAY, PBCT, PFSW, PHH, PN, PPO, PRAH, QCRH, QLGC, RENN, RPTP, RTRX, RXDX, SAGE, SAL, SBCP, SBUX, SEIC, SGU, SHLX, SIMO, SLAB, SMFG, SNPS, SOXX, SPR, SSNI, STRP, SUPN, SWKS, TCX, TMUS, TTMI, TW, TXTR, UEC, UEPS, UUU, VIMC, YLCO, ZTS

Stocks that traded to 52 week lows: AA, AHC, AMBR, ANR, ARO, ASM, AVH, AVP, AXE, BIOS, BLT, BOOM, BOXC, BTU, BWINB, CCG, CEN, CENX, CKP, CLD, CLUB, CNS, CNW, CP, CPA, CRD.B, CTCM, CTL, CUR, CVSL, CZR, CZZ, DEJ, DOM, EDD, EQGP, ERJ, ESEA, ESIO, EVLV, FAX, FCO, FHCO, FPO, FSNN, GALT, GGB, GMCR, HART, HGG, HGT, HNRG, HWCC, ICAD, INF, INVE, IO, KIQ, KSU, LF, LL, MCF, MFV, MIND, MNI, MTRX, MXWL, NATH, NAV, NCS, NETE, NOR, NRP, NSC, NSPH, NVET, OFG, PGND, POT, PPSI, PQ, PRI, PSB, QUIK, QUMU, RBCN, RDS.B, REXI, RNO, RNWK, SHLO, SJT, SMRT, SMT, STB, SYX, TGH, TNC, TRCO, TRIV, TRMB, VKTX, VNCE, WILC, WPG, WTW, WYNN, YLCO, YRCW, ZQK

ETFs that traded to 52 week highs: SMH, SOXX

ETFs that traded to 52 week lows: EWM, FXY, JJG, KOL

11:35 am PartnerRe and Axis Capital (AXS) announce that the SEC has declared their S-4 statement effective; special meeting of shareholders to be held on July 24 (PRE) :  

11:33 am Gannett says it has completed the acquisition of the remaining 59.36% interest in the Texas-New Mexico Newspapers Partnership that it did not own from Digital First Media (GCI) : The deal was completed through the assignment of Gannett's 19.49% interest in the California Newspapers Partnership and additional cash consideration. As a result, Gannett will own 100% of the Texas-New Mexico Newspapers Partnership and will no longer have any ownership interest in California Newspapers Partnership. With this acquisition, the publishing segment of Gannett provides hundreds of outstanding affiliated digital, mobile and print products in 92 local markets throughout 33 states plus Guam, and in 16 markets in the U.K.

11:32 am Currency Commentary: DXY Pushing Higher (:SUMRX) :

  • The Dollar Index is seeing a rally to kick off the week. The DXY was testing 97 for supporting early trade. But it has been able to lift off that area following a solid round of economic data to start off a busy week. Personal Income, ISM Index, a Markit PMI revision and construction spend all outpaced expectations. PCE Prices and Spending fell short of expectations but the strong ISM and Construction are overshadowing that news. The 97.75 highs from next week will set up as a key level in early trade. 
  • The euro has run into some resistance at it s 50 sma (1.0960) as the region kicks off a crucial week for the Greek debt issue. The region saw a steady round of Manufacturing PMI data for starters, but the key remains the Greek issue as a Friday IMF payment looms. Early on, market participants were pointing to comments from Greece's Interior Minister which suggested some parts of the program could be delayed. This would suggest the potential for some compromise. But we have yet to hear any confirmation from this from the EU side. We have heard chatter of deals before, yet are still awaiting some sort of bargain. And over the weekend, Greece's PM Tspiras provided comments that suggested the two sides remains far apart. So this will remain a crucial issue over the course of the week. Also of interest will be the ECB meeting on Wednesday. Certainly the central bank will attempt to settle any nerves on potential liquidity issues in the region if Greece was in fact to default.
  • The pound is testing its 50- and 100-sma as it slides to below 1.52 for the first time in three weeks. Cable has now given up over half of its recent rally, The country saw its May Manufacturing PMI survey miss expectations which is helping the slide. The Bank of England is set to meet on Thursday but is not expected to make any changes to its current plan. 
  • The yen continued its decline as it hit a fresh multi-year low (124.68) this morning. The Manufacturing PMI number came in line with expectations and was flat from the prior month. This suggests the country continues to see growth albeit at a very modest pace (BONDX, FOREX).

11:30 am Marsh McLennan reaches agreement to acquire Leeds-based SME Insurance Services; financial terms not disclosed, with closure expected in Q3 2015 (MMC) :  

11:29 am Talen Energy confirms completion of spin-off from PPL Corp (PPL); to begin trading tomorrow (:TLN) : Talen Energy was formed when the competitive power generation business of PPL Corporation (PPL) was spun off and immediately combined with the competitive generation business owned by private equity firm Riverstone Holdings, LLC. Upon completion of these transactions, PPL shareholders owned 65 percent of Talen Energy's common stock; affiliates of Riverstone owned 35 percent. On a pro-forma basis, the assets comprising Talen Energy generated annual revenue of $4.3 billion in 2014.

11:25 am Puma Biotech. announces the presentation of 'positive results' from the Phase III clinical trial of PB272 for the extended adjuvant treatment of breast cancer (PBYI) : The safety results of the study showed that the most frequently observed adverse event for the neratinib-treated patients was diarrhea, with approximately 39.9% of the neratinib-treated patients experiencing grade 3 or higher diarrhea (1 (0.1%) patient had grade 4 diarrhea). Patients who received neratinib in this trial did not receive any prophylaxis with antidiarrheal agents to prevent the neratinib-related diarrhea.

  • The primary endpoint of the trial was invasive disease free survival (DFS). The results of the trial demonstrated that treatment with neratinib resulted in a 33% reduction of risk of invasive disease recurrence or death versus placebo (hazard ratio = 0.67, p = 0.009). The 2-year DFS rate for the neratinib arm was 93.9% and the 2-year DFS rate for the placebo arm was 91.6%.
  • The secondary endpoint of the trial was disease free survival including ductal carcinoma in situ (DFS-DCIS). The results of the trial demonstrated that treatment with neratinib resulted in a 37% reduction of risk of disease recurrence including DCIS or death versus placebo (hazard ratio = 0.63, p = 0.002). The 2-year DFS-DCIS rate for the neratinib arm was 93.9% and the 2-year DFS-DCIS rate for the placebo arm was 91.0%. 
  • "We are very pleased with the results of the ExteNET trial with neratinib. This represents the first trial with a HER2 targeted agent that has shown a statistically significant benefit in the extended adjuvant setting, which we believe provides a meaningful point of differentiation for neratinib in the treatment of HER2 positive breast cancer... We look forward to proceeding with the regulatory filing for neratinib for the extended adjuvant treatment of breast cancer currently anticipated in the first quarter of 2016."

11:13 am Aerojet Rocketdyne announces the CEO Scott Seymour will retire, and that Eileen Drake will succeed him as CEO, effective today (AJRD) : Drake joined Aerojet Rocketdyne in March as chief operating officer. She was previously with United Technologies Corporation (UTX), where she served as president of Pratt & Whitney AeroPower's auxiliary power unit and small turbojet propulsion business.

11:10 am MGE Energy's Madison Gas and Electric announced $40 mln unsecured revolving credit facility that will be used for general corporate purposes (MGEE) :  

11:06 am BlackRock an Pemex have signed an MOU to develop energy related infrastructure in Mexico (BLK) : Through the MOU, BlackRock will provide industry expertise, risk management capabilities and sources of financing to support Pemex's mission to enhance its market position in Mexico.

11:03 am Pegasystems and Ericsson (ERIC) partner to enable Digital Telco Transformation (PEGA) : The cos have formed a global partnership to help telecommunications service providers utilize customer data and business context to anticipate customer needs in real time. Through the combination of the Pega Marketing application's Next-Best-Action capabilities and Ericsson's existing OSS/BSS product and services portfolio, telco operators will be able to deliver personalized and consistent interaction to enhance every phase of a customer's journey. This partnership will contribute to Ericsson's ability to deliver Digital Telco Transformation.

11:00 am Time Warner Cable announces that EVP and CFO Arthur Minson will leave the company, effective immediately (TWC) : Minson will remain as an advisor to the company until the Charter (CHTR) transaction closes. Serving as acting co-CFOs in his place will be William F. Osbourn, Jr., who currently serves as Senior Vice President-Controller and Chief Accounting Officer, and Matthew Siegel, who currently serves as Senior Vice President and Treasurer. Minson is leaving to join WeWork as President and Chief Operating Officer

11:00 am PPL Corp reaffirms guidance after spinning off competitive energy business, which was merged with Riverstone, now called Talen Energy (:TLN) (PPL) : Co is reaffirming its 2015 forecast range of $2.05 to $2.25 per share for regulated utility earnings from ongoing operations and expects to achieve compound annual earnings growth of 4 to 6 percent through at least 2017 as the company continues a major, corporate-wide effort to rebuild and modernize transmission and distribution networks to make them even more reliable.

10:59 am HomeAway shares +6% after Priceline's (PCLN) Kayak announced an agreement to display HomeAway's vacation rentals on its site (AWAY) : The co's said that integration is expected to be live by the end of the year with nearly 200,000 property listings worldwide.

10:55 am General Electric issues a statement on a potential increase in Connecticut Taxes (GE) : Co stated: "Reports that Connecticut officials intend to raise taxes by another $750 million dollars are truly discouraging. Retroactively raising taxes again on Connecticut's residents, businesses and services makes businesses, including our own, and citizens seriously consider whether it makes any sense to continue to be located in this state.

  • The Connecticut economy continues to struggle as other states offer more opportunities and a better environment for business growth. It is essential that Governor Malloy and legislative leaders find a more prudent and responsible path forward for Connecticut and its citizens in their current budget negotiations."

10:46 am Seattle Genetics announces Adcetris data presentations, in the AETHERA post-transplant consolidation setting for Hodgkin lymphoma, and in frontline diffuse large B-cell lymphoma (SGEN) : Co announced several Adcetris (brentuximab vedotin) data presentations in the AETHERA post-transplant consolidation setting for Hodgkin lymphoma (HL) and in frontline diffuse large B-cell lymphoma

  • In a Multivariate analysis of PFS from the AETHERA trial, a phase 3 study of brentuximab vedotin consolidation after autologous stem cell transplant for HL: 
    • Data were reported from a multivariate analysis of the effects of demographics, baseline disease characteristics and other risk factors on progression-free survival (PFS) from the phase 3 AETHERA clinical trial. 
    • After adjusting for several clinical factors in a multivariate regression analysis, consolidation treatment with ADCETRIS was significantly associated with improved PFS compared with placebo and was more importan. Results show consistent PFS benefit of ADCETRIS consolidation therapy, regardless of the clinical factors, further supporting ADCETRIS use as consolidation in HL patients following autologous stem cell transplant. 
  • Updated results of a phase 2 trial of brentuximab vedotin combined with RCHOP in frontline treatment of pts with high-intermediate/high-risk DLBCL Data, were reported from 53 patients with a median age of 67 years.
    • Key findings included: Of 51 evaluable patients across both dose cohorts, 41 patients (80 percent) obtained an objective response, including 34 patients (67 percent) with a complete remission and seven patients with a partial remission. Five patients (10 percent) had progressive disease. Five patients did not have end of treatment assessments. 
    • The estimated PFS rate at six months was 79 percent and at 12 months was 65 percent. Antitumor activity was not significantly different between the two dosage arms. Of 25 evaluable patients who had CD30-positive disease, 21 patients (84 percent) obtained an objective response, including 19 patients (76 percent) with a complete remission and two patients (eight percent) with a partial remission. 

10:45 am OncoGenex Pharma announces that results from an exploratory analysis of the Phase 2 Borealis-1 trial showed that metastatic bladder cancer patients with poor prognostic features benefited from apatorsen 600mg (OGXI) : The co announced that results from an exploratory analysis of the Phase 2  Borealis-1 trial showed that metastatic bladder cancer patients with poor prognostic features benefited from apatorsen 600mg added to first-line chemotherapy compared to chemotherapy alone 

  • Patients in the trial with a Karnofsky Performance Status (:KPS) of 80 percent or less, a common indicator of poor prognosis, experienced a 50 percent reduction in risk of death with the addition of apatorsen therapy (OS HR = 0.50). 
  • Exploratory analysis of study results showed that survival outcome was impacted by the following prognostic risk factors: KPS, liver involvement, low hemoglobin and high alkaline phosphatase. Patients who had these poor prognostic features benefited most from 600mg apatorsen therapy. Median overall survival in the poor prognostic group was 11.9 months with 600mg apatorsen + gemcitabine/cisplatin compared to 9 months with gemcitabine/cisplatin alone (OS HR = .77). Importantly, 33 percent of patients in the trial had a KPS less than or equal to 80 percent, which was found to be the single most important risk factor for poor prognosis. These lower KPS, high-risk patients experienced a 50 percent reduction in risk of death (OS HR = 0.50) when 600mg apatorsen was added to chemotherapy.
  • Overall treatment was well tolerated. Most common Grade =3 adverse events (AEs) were neutropenia, anemia, thrombocytopenia and hypertension.  Frequency of =3 Grade toxicities were: 89 percent (GC.TO), 93 percent (GC+A 600) and 95 percent (GC+A 1000). GC+A 1000 had a higher treatment discontinuation rate due to AEs.
  • Over the next 12 months, the Company expects a number of significant clinical events from several apatorsen clinical trials within the ORCA trial program that are currently evaluating patients in some of the most aggressive tumor types.

10:44 am Pure Cycle says it has received its first royalty check from the Sky Ranch Oil and Gas lease (PCYO) : "We are pleased to announce that Pure Cycle has received its first Oil & Gas royalties totaling approximately $218,000 for oil production from its mineral interest from two wells at Sky Ranch. The amount included royalties from oil production from commencement of each well through April 15, 2015, which represents approximately two months of production. The first well generated royalty revenue of approximately $173,000, 20% gross (net of taxes), based on the Company's 3/8ths interest of the total production of this 1,280 acre pooled mineral estate."

10:35 am Northwest Biotherapeutics announces data to date from DCVax-Direct Phase 1 trial: 27 of 39 patients still alive at up to 18 months after first injection (NWBO) : Co released new data on its Phase I trial of DCVax-Direct for direct injection into all types of inoperable solid tumors. The patients enrolled in the trial had late stage cancers, with an average of three inoperable tumors. The patients had failed multiple prior therapies and had a poor prognosis. The trial enrolled 40 patients, and 39 were evaluable. The trial tested three different dose levels of DCVax-Direct, two different methods of activating the dendritic cells that comprise DCVax-Direct, and a dozen different cancers. Findings to date include encouraging survival data and substantial induction of immune checkpoint expression (PDL-1). Findings to date include the following:

  • 27 of 39 patients are still alive at up to 18 months after first injection. 
  • Patient survival correlates with the method of dendritic cell activation used. With the preferred method, 18 of 21 patients are still alive. 
  • Treatment effects have been observed in diverse cancers, including lung, breast, colorectal, pancreatic, sarcoma, melanoma, neuro-endocrine and other cancers. 
  • Patient survival correlates with the number of DCVax-Direct injections.
Induction of PDL-1 immune checkpoint expression was seen in 64% of evaluable patients (14 of 22) following DCVax-Direct treatment. This suggests that the tumors are putting up defenses against the immune responses induced by DCVax-Direct, and marks these patients as potential candidates for treatment with checkpoint inhibitor therapies. Co plans to pursue Phase II trials in non-small cell lung cancer and sarcoma, as well as a Phase II trial for multiple diverse types of cancers similar to the Phase I study. The Company also plans to expand the trial sites to include countries beyond the U.S.

10:27 am South Jersey Inds subsidiary South Jersey Gas announces filing a petition with the NJ Board of Public Utilities to reduce components of its rates (SJI) : SJG filed its annual Basic Gas Supply Service petition, which proposes a decrease of approximately $12.11 to an average 100-therm monthly residential bill. SJG also filed its annual Conservation Incentive Program petition, proposing a decrease of approximately $3.16 to an average 100-therm monthly residential bill. In addition, SJG filed a petition seeking a decrease to its Energy Efficiency Tracker rate by approximately $1.36 on a 100-therm monthly residential bill.

10:14 am Market View: SPY, QQQ, DIA now back on session lows in volatile 1st hour trading as the new month gets underway; SPX now @ 2105.64 -1.75 (:TECHX) :  

10:11 am Hill International: Bulldog Investors shareholder group announces that ISS proxy advisory firm has recommended a shareholder vote for its director nominees at the co's upcoming annual meeting (HIL) : Group quoted ISS in stating: "The company's underperformance over a prolonged period, coupled with the board's hasty rejection of an unsolicited offer at a substantial premium to HIL's trading price, suggests that additional shareholder perspective on the board might be beneficial. The dissident case for change is further bolstered by a persistent pay-for-performance disconnect at the company, and the board's lack of responsiveness to related shareholder concerns. As such, support for dissident nominees Andrew Dakos and Phillip Goldstein is warranted."

10:10 am Terex says it has closed a new $350 mln asset-backed securitization transaction (TEX) : The Company also announced it has completed a re-pricing of its Euro term loan that is expected to reduce its cash interest costs by approximately $1 million annually.

10:06 am CEL-SCI Corp announces that 26 patients were enrolled in its ongoing Phase III trial of Multikine in May, bringing to the total to over 463 as of May 31, 2015 (CVM) :  

10:02 am Market View: SPY, DIA, & QQQ with a solid bounce off of earlier lows following the 10:00 am ET economic data points; SPX now @ 2112.58 +5.19 (:TECHX) :  

9:42 am Opening Market Summary: Influential Sectors Display Early Strength (:WRAPX) : The stock market began the day on a modestly higher note with the Dow Jones Industrial Average (+0.3%) in the early lead while Nasdaq Composite (+0.2%) and S&P 500 (+0.1%) follow right behind.

Six of ten sectors display early gains with heavily-weighted health care (+0.5%), technology (+0.3%), and financials (+0.3%) holding the early lead. On the flip side, energy (-0.2%) and industrials (-0.1%) display slim losses.

Elsewhere, Treasuries hover just above their flat lines with the 10-yr yield down a basis point at 2.12%.

April Construction Spending (consensus 0.8%) and the May ISM Index (consensus 51.9) will both be reported at 10:00 ET.

9:38 am Market View: Strength in the precious metals complex lifts the miners in early trading with NUGT +2.4%, GDX +0.75%, & GDXJ +0.85% (:TECHX) :  

9:38 am Novartis AG announced new data from two Phase II studies of Zykadia, as well as one Phase II study of Tafinlar in combination with Mekinist (NVS) : Data from these studies were presented at the 51st Annual Meeting of the American Society of Clinical Oncology in Chicago.

  • The results of the Zykadia studies -- ASCEND-2 and ASCEND-3 -- reinforce the efficacy of the medicine in patients with anaplastic lymphoma kinase-positive (ALK+) NSCLC who had received previous treatment with an ALK inhibitor and in those receiving an ALK-targeted therapy for the first time. Overall response rates seen in these trials were 38.6% and 63.7%, respectively, based upon investigator assessment. Comparable ORR results were observed in patients with ALK+ NSCLC who entered the studies with brain metastases (33% and 58%, respectively)
  • Separately, the study of dabrafenib in combination with trametinib in patients with metastatic BRAF V600E-mutation positive NSCLC who had failed at least one round of chemotherapy demonstrated an ORR of 63% in this population

9:31 am Archer-Daniels announces the commencement of cash tender offers to purchase the 11 series of Debentures for up to $1 bln (ADM) :  

9:29 am On the Wires (:WIRES) :

  • NetSuite Inc. (N) announced that Thos. Bake, an online and catalog retailer of premium outdoor furniture, has modified its ecommerce website with NetSuite SuiteCommerce
  • Pope Resources (POPE) announced a $3.3 million sale to Quadrant Homes of 33 single-family lots located in the southern portion of the Partnership's Harbor Hill project in Gig Harbor, Washington
  • Kopin Corporation (KOPN) announced it has received a production order for high-brightness color SXGA displays in support of full-color helmet-mounted display products for US Navy's MH-60 helicopters
  • ITC Lake Erie Connector, a subsidiary of ITC Holdings (ITC) announced it has filed a major permit application with the U.S. Department of Energy for the ITC Lake Erie Connector merchant transmission line. The purpose of the DOE filing is to obtain the Presidential Permit necessary for international border-crossing projects.
  • The Maryland Public Service Commission approved a settlement that allows Maryland American Water, a subsidiary of American Water (AWK) to increase water rates. The settlement approved by the PSC grants an increase of approximately $490,000 in annual revenue. The company had filed the rate request with the PSC on December 19, 2014, seeking an annual revenue increase of approximately $813,000

9:29 am On the Wires (:WIRES) :

  • BlackBerry Limited (BBRY) announced that Grand River Hospital has chosen BlackBerry 10 smartphones, BBM Protected, and BES12: a multi-OS EMM solution by BlackBerry, to enable secure communications for their clinicians and staff
  • Mexico's Federal Economic Competition Commission has approved the sale of Tyson Foods' (TSN) poultry business in Mexico to Pilgrim's Pride, a wholly-owned subsidiary of JBS SA
  • Vail Resorts (MTN) announced the hiring of David T. Shapiro as executive vice president and general counsel of the Company, effective July 13, 2015
  • JetPay Corporation (JTPY) and Rezzcard are partnering to provide electronic payment options to tenants of multifamily affordable housing properties. Working with JetPay's Card Services team, Rezzcard will offer MAC, a Visa-branded prepaid debit card, and Rezzcard mobile app, to tenants nationwide in public, Section 8, tax credit subsidized and workforce housing developments.

9:15 am S&P futures vs fair value: +6.90. Nasdaq futures vs fair value: +19.70. (:WRAPX) : The stock market is on track for a higher open as futures on the S&P 500 trade seven points above fair value. Index futures spent the early morning hours near their flat lines, but spiked to highs following rumors that a deal between Greece and its creditors will be announced today. However, that rumor was struck down within 15 minutes of making the rounds, but futures continue holding the bulk of their gains.

As for Greece, the country remains in limbo and is scheduled to make four payments totaling EUR1.60 billion to the International Monetary Fund this month, with the first one due Friday.

Domestically, Treasuries retreated on the rumors of a deal, but they returned to unchanged shortly thereafter. The 10-yr note is currently flat with its yield at 2.13%.

On the corporate front, Altera (ALTR 51.80, +2.95) has climbed 6.0% in pre-market after agreeing to be acquired by Intel (INTC 34.25, -0.21) for $54.00/share or $16.70 billion.

9:11 am Tenet Healthcare and Saint Louis University have entered into a definitive agreement for the sale of Saint Louis University Hospital to SLU (THC) : The transaction is subject to customary regulatory approvals and other closing conditions and is expected to be completed during the third quarter of 2015.

  • In connection with this transaction, the company anticipates recognizing a pre-tax non-cash impairment charge of ~$150-160 million ($95 million to $100 million after-tax) during the second quarter of 2015.

9:08 am STAG Industrial sold 440K shares of stock at avg. price of $22.11 at the market in May (STAG) : Under its "At the Market" stock offering program, the Company issued an aggregate of 440,054 shares of common stock in May 2015 at a weighted average offering price per share of $22.11, receiving gross proceeds of approximately $9.7 million and net proceeds of approximately $9.6 million. The Company used the net proceeds of the ATM to fund acquisitions, to repay indebtedness, and for working capital and other general corporate purposes.

9:07 am Immunomedics announces that a majority of patients with heavily-pretreated, metastatic gastrointestinal cancers responded to sacituzumab govitecan, with partial responses and durable stable disease in a mid-stage clinical study (IMMU) : Co announced that a majority of patients with heavily-pretreated, metastatic gastrointestinal cancers responded to sacituzumab govitecan, the Company's first-in-class antibody-drug conjugate (ADC), with partial responses and durable stable disease in a mid-stage clinical study. A total of 65 patients with various types of gastrointestinal cancers had been enrolled into this multicenter study to receive sacituzumab govitecan weekly for the first 2 weeks of a 3-week cycle. At the time of analysis, 60 patients had at least one post-treatment evaluation for response by computed tomography according to rules set by the Response Evaluation Criteria In Solid Tumors. Despite the late-stage setting, the overall disease control rate (partial response + stable disease) for all 60 assessable patients was 57%, including 2 esophageal cancer patients and 1 colorectal cancer patient with a partial response. While patient follow-up is continuing, interim analysis of survival data revealed a favorable outcome in both progression-free survival (PFS) and overall survival (:OS).

9:06 am Amgen announces results from a randomized, double-blind, placebo-controlled, multicenter Phase 3 study evaluating the treatment effect of adjuvant Prolia (AMGN) : The trial met its primary endpoint of time from randomization to first clinical fracture (HR=0.5, 95 percent CI 0.39-0.65, p

9:06 am Aduro Biotech announces ASCO Presentation of 'Encouraging Data' from ongoing Phase 1b Clinical Trial of its Immunotherapy for the treatment of Mesothelioma (ADRO) : At the time of the ASCO presentation, the multi-center Phase 1b study had enrolled 36 patients who were chemotherapy-nave, had unresectable MPM, good performance status and adequate organ function. Under the trial design, eligible patients received two prime vaccinations with CRS-207 two weeks apart, followed by up to six cycles of standard of care pemetrexed and cisplatin chemotherapy three weeks apart and two CRS-207 boost vaccinations three weeks apart. Clinically stable patients receive CRS-207 maintenance vaccinations every eight weeks and are followed every eight weeks until disease progression. Objectives of the study are safety, immunogenicity, objective tumor responses and tumor marker kinetics.

  • The median time of treatment was 6.9 months. Median duration of response was 5.0 months and median progression free survival was 7.4 months. No treatment-related serious adverse events or unexpected toxicities were observed. Treatment, follow-up and immune response evaluations are ongoing.
  • Of the 32 evaluable patients, disease control was observed in 94% (30/32), including 60% (19/32) with partial responses and 34% (11/32) experiencing stable disease following treatment with CRS-207 and chemotherapy.

9:06 am Molycorp confirms it has elected to take advantage of the 30-day grace period with respect to the $32.5 mln semi-annual interest payment due June 1, 2015 on its 10% Senior Secured Notes due 2020 (MCP) : The co notes that this election will not trigger any cross-default provisions in other outstanding debt prior to the end of the grace period and should not affect current operations.  As previously disclosed, the Company has retained financial and legal advisors to assist the Company to restructure its debt.  The Company will use the grace period to continue to evaluate different options related to such debt restructuring.

9:06 am Chart Industries acquires Thermax; sees deal accretive to earnings within twelve months (GTLS) : Co has entered into a definitive agreement to acquire vaporizer manufacturer Thermax. Terms of the transaction were not disclosed. Thermax will be operated as part of Chart's Distribution & Storage business segment. The transaction is expected to be completed in the next 60 days after satisfaction of customary closing conditions. Chart expects the acquisition to be accretive to future earnings within the first twelve months.

9:06 am Northrop Grumman announces it has been awarded a combined order of $111 mln to the previously awarded firm-fixed-price contract from the U.S. Air Force to provide hardware and support for the Large Aircraft Infrared Countermeasure system (NOC) : Under terms of the contract modification, NOC will deliver additional transmitters, missile warning sensors, processors, lasers, control interface units and supporting equipment to the Air Force and various customers around the globe through April 2017. In addition to legacy hardware, the delivery will include a modernized control interface unit replacement.

9:05 am ITC Holdings files permit application with U.S. Department of Energy for the ITC Lake Erie Connector project (ITC) :

  • Co announced it has filed a major permit application with the U.S. Department of Energy (:DOE) for the ITC Lake Erie Connector merchant transmission line. The purpose of the DOE filing is to obtain the Presidential Permit necessary for international border-crossing projects.
  • The ITC Lake Erie Connector is a proposed 1000 MW, bi-directional, High-Voltage Direct Current (:HVDC) merchant transmission line that will provide the first direct link between the markets of the Ontario Independent Electricity System Operator (IESO) and PJM Interconnection, LLC (:PJM).
  • The ITC Lake Erie Connector will enable transmission customers to more efficiently access energy, capacity, and renewable energy credit opportunities in both markets.

9:05 am Ryerson appoints Erich S. Schnaufer interim Chief Financial Officer (RYI) :

  • Co announced the appointment of Erich S. Schnaufer to the position of interim chief financial officer, effective June 1, 2015. Mr. Schnaufer is currently the company's controller and chief accounting officer. He succeeds Edward J. Lehner who was appointed as the company's president and CEO.
  • Schnaufer joined Ryerson in 2005 and was promoted in 2007 to controller and chief accounting officer responsible for accounting, tax and financial reporting. Prior to joining Ryerson, Mr. Schnaufer held senior financial and accounting management roles at several public companies including Alternative Resources Corporation and Midway Games.

9:05 am Global Partners intends to commence a private offering of $300 mln in aggregate principal amount of senior unsecured notes due 2023 (GLP) : Co intends to use the net proceeds from the offering to repay a portion of the borrowings outstanding under its revolving credit facility.

9:04 am Crestwood Midstream Partners announces Executive promotions and organizational changes; Heath Deneke promoted to Chief Operating Officer; Bill Gautreaux promoted to Chief Marketing Officer (CMLP) : Co announced several promotions within Crestwood's senior management team, effective immediately. Additionally, Crestwood announced a new internal organizational structure forming a Pipeline Services Group and Supply and Logistics Group. The Pipeline Services Group will consist of all Crestwood's natural gas, crude oil and water gathering systems, pipelines and compression, processing plants and natural gas storage facilities in the US. The Supply and Logistics Group will include all natural gas liquids (NGL) and crude oil marketing, terminals and fractionation facilities, crude oil and NGL transportation fleet assets, NGL storage and US Salt. Crestwood anticipates that it will continue to report financial and operating data in its existing three segment structure of Gathering and Processing, Storage and Transportation, and Crude and NGL Services. 

  • Heath Deneke, formerly President of the Natural Gas Business Unit, has been promoted to Chief Operating Officer and Head of the Pipeline Services Group. 
  • Brian Freed, formerly Vice President of Crude Logistics, has been promoted to Senior Vice President of Western US Commercial Operations. 
  • Mark Mitchell, formerly Senior Vice President of Natural Gas Business Unit, has been promoted to Senior Vice President of Eastern US Commercial Operations. 
  • Bill Gautreaux, formerly President of the Liquids & Crude Business Unit, has been promoted to Chief Marketing Officer and Head of the Supply and Logistics Group.
  • Kevin Hall joined the Crestwood organization in April 2015 as the Vice President of Transportation.

9:04 am OncoMed Pharma announces updated Demcizumab data in non-small cell lung cancer, showing a 50% response rate when combining Demcizumab with Abraxane and Gemcitabine in pancreatic cancer (OMED) : Co presented data from its Phase 1b clinical trials of demcizumab in advanced pancreatic patients who have not received prior treatment for locally advanced or metastatic disease. Demcizumab, when combined with standard of care Abraxane plus gemcitabine resulted in a 50 percent response rate, progression-free survival of nine months and overall survival of ten months in an all-comer patient population.

  • Of 28 patients evaluable for efficacy who received the three drug combination, partial responses were seen in 14 patients (50%) and 11 patients (39%) achieved stable disease as measured by RECIST criteria, resulting in an 89 percent overall clinical benefit rate in this all-comer patient population. Median progression-free survival was 9.0 months and median overall survival was 10.1 months for those patients who received the demcizumab-Abraxane-gemcitabine combination. 
  • Current standard-of-care treatment for advanced pancreatic cancer with Abraxane plus gemcitabine has median progression-free survival of 5.5 months and median overall survival of 8.5 months. Biomarker analysis of surrogate makers in whole blood cells demonstrated target engagement of demcizumab that down regulated Notch pathway gene expression at all doses and up regulated genes associated with angiogenesis. These results are consistent with the mechanism of action observed for demcizumab in preclinical experiments and also support the selection of the demcizumab Phase 2 dose in pancreas cancer of 3.5mg/kg every two weeks

9:04 am SINA announces agreement with co's CEO for $456 mln cash investment; SINA to issue 11 mln new shares (SINA) : Co announced that it has entered into a legally binding subscription agreement with Mr. Charles Chao, Chairman of SINA's board of directors and Chief Executive Officer, for the issuance and sale of 11,000,000 newly issued ordinary shares of the Company to Mr. Chao. Pursuant to the agreement, Mr. Chao will subscribe for and purchase directly or through a special purpose vehicle beneficially owned and controlled by him, 11,000,000 newly issued ordinary shares of SINA for a total purchase price of approximately US$456 million in cash.

  • Mr. Chao has agreed to subject all the shares he or his affiliate will acquire in the transaction to a contractual lock-up restriction for six months after the closing.

9:04 am Pioneer Natural Resources announces a purchase and sale agreement with an affiliate of Enterprise Products Partners (EPD) to sell their Eagle Ford Shale Midstream business for $2.15 bln (PXD) :

  • Co announced that PXD and Reliance Holding USA, Inc. ("Reliance") have entered into a purchase and sale agreement with an affiliate of Enterprise Products Partners L.P. to sell their Eagle Ford Shale Midstream business ("EFS Midstream") for $2.15 bln, subject to regulatory approvals and normal closing adjustments.
  • Pioneer owns 50.1% of EFS Midstream and Reliance owns the remaining 49.9%. Pioneer and Reliance will also benefit from fee reductions under existing downstream processing and transportation contracts with Enterprise in exchange for extending the contract term to 20 years and dedicating additional Eagle Ford Shale volumes to Enterprise.
  • The reduced fees are expected to benefit Pioneer and Reliance over the original terms of the downstream contracts by ~$200 mln on a net present value basis at 10%. These reduced fees will primarily be reflected as improvements in future realized prices.
  • Enterprise has also agreed to spend $270 mln over the next ten years on new facilities, connections and expansions to support the continuing development of the Eagle Ford Shale resource. The purchase price for the EFS Midstream business will be paid by Enterprise in two installments: $1.15 bln at closing, which is expected to occur early in the third quarter of 2015, and $1 bln twelve months after closing.

9:04 am City Holding Co to acquire three branches in Lexington, Kentucky, from American Founders Bank; expects the Acquisition to be immediately accretive to earnings per share (CHCO) : Co to acquire three branches in Lexington, Kentucky, from American Founders Bank. 

  • Under the terms of the agreement, City National will pay a deposit premium of 5.5% on non-time deposits, excluding repurchase agreements. Also, City National will pay a 1.0% premium on loan balances acquired.
  • Based on May 15, 2015 balances, the aggregate premium would have been approximately $6.4 million. 
  • City expects the Acquisition to be immediately accretive to earnings per share.

9:03 am Prologis completes $5.9 bln KTR acquisition; expected to be accretive to 2015 Core FFO by approximately $0.09 per share (PLD) : PLD completes $5.9 bln KTR acquisition.

  • The deal is expected to be accretive to 2015 Core FFO by approximately $0.09 per share.
  • As a result, Prologis increased its full-year 2015 Core FFO guidance range to $2.16 to $2.22 per diluted share from $2.07 to $2.13 per diluted share.  

9:03 am Ariad Pharm presents updated clinical data on brigatinib in Patients with ALK+ Non-Small Cell Lung Cancer at the 2015 ASCO Meeting; 'updated brigatinib data show an objective response rate of ~70% in crizotinib-resistant ALK-positive NSCLC patients' (ARIA) :

  • Co announces updated clinical data on its investigational tyrosine kinase inhibitor (:TKI), brigatinib (AP26113), in patients with anaplastic lymphoma kinase positive (ALK+) advanced non-small cell lung cancer (:NSCLC) from an ongoing Phase 1/2 trial. 
  • The current results include more mature efficacy data for brigatinib, including updated response rates and median duration of response in ALK+ NSCLC patients, as well as more extensive safety data for all patients in the trial. Of the 78 ALK+ NSCLC patients evaluable for response, 58 (74%) demonstrated an objective response to brigatinib. Fifty responses were confirmed by repeat imaging studies. The "waterfall plot" analysis demonstrated tumor shrinkage in nearly all ALK+ NSCLC patients, with 25 patients (36%) experiencing 100% shrinkage of the target lesion. 
  • "The updated brigatinib data show an objective response rate of ~ 70% in crizotinib-resistant ALK-positive NSCLC patients. In addition, the median progression-free survival in this second-line patient group is now over the one-year mark."
  • A separate, pivotal global Phase 2 trial of brigatinib in patients with locally advanced or metastatic ALK+ NSCLC who have progressed on crizotinib is enrolling patients.

9:02 am BNC Bancorp announces the acquisition Of CertusBank, N.A. branches with $284 million in customer deposits, approximately $210 million in loans (BNCN) : The transaction is expected to be immediately accretive to BNC's fully diluted earnings per share, excluding deal costs

9:02 am TransCanada announced that its Prince Rupert Gas Transmission Ltd. (PRGT) project has entered into project agreements with the Doig River First Nation, Halfway River First Nation and Yekooche First Nation of northern B.C. (TRP) :

  • The project agreements provide each First Nation with financial and other benefits related to the pipeline projects. Specifically, the project agreements provide annual legacy payments for the duration of the commercial operation of the pipelines, plus immediate benefits on signing, and at other key project milestones.
  • Pipeline project agreements are part of a comprehensive approach to working with First Nations on liquefied natural gas opportunities, including developing skills training, employment and involving First Nations in developing business opportunities.

9:02 am Blue Bird: NASDAQ has determined that the co's common stock satisfies all requirements for initial listing on the Nasdaq Global Market (BLBD) :  

9:01 am Teekay Offshore to construct three shuttle tankers to service new East Coast Canada contracts (TOO) : Co announced that it has entered into new long-term contracts with a group of companies that includes Chevron Canada, Husky Energy, Mosbacher Operating Ltd., Murphy Oil, Nalcor Energy, Statoil and Suncor Energy to provide shuttle tanker services for their East Coast Canada oil production. These 15-year contracts, plus extension options, will initially be serviced by one of Teekay Offshore's existing shuttle tankers. Teekay Offshore will enter into shipbuilding contracts to construct three Suezmax-size, DP2 shuttle tanker newbuildings with a South Korean shipyard for a fully built-up cost of approximately $365 million, with an option to order one additional vessel should a fourth vessel be required. The three firm vessels are expected to be delivered in the fourth quarter of 2017 through the first half of 2018. The Partnership intends to initially finance the installment payments for the shuttle tanker newbuildings with a portion of its existing liquidity and it expects to secure long-term debt financing for the vessels prior to their scheduled deliveries.

9:01 am Peregrine Pharma announces the presentation of preclinical and clinical translation data highlighting its phosphatidylserine targeting platform and bavituximab (PPHM) : New data generated from additional assays further validates previous data showing that ex vivo drug treatment with bavituximab, alone and in combination with docetaxel, elicits an immune response in tumors from NSCLC patients with negative PD-L1 and low PD-1 expression. Specifically, data showed activation of tumor infiltrating lymphocytes (TILs) by polarization of the tumor microenvironment from immunosuppressive to immuno-stimulatory. Results in the pilot translational study also identified PD-L1 and PD-1 expression as a potential biomarker of response to bavituximab treatment, suggesting that the interruption of the PD-1/PD-L1 axis may enhance the bavituximab effect in lung cancer.

  • In another study, researchers found that the combination of PS blockade and an anti-PD-1 antibody promoted strong and localized anti-tumor responses without the side-effects of systemic immune activation. In models of melanoma, the combination of PS blockade with either an anti-PD-1 or anti-CTLA-4 antibody showed significantly superior tumor growth inhibition over single treatment, with many subjects achieving complete tumor regressions. No toxicity was observed in any of the treatment groups following multiple treatment doses. 

9:00 am NASDAQ reports May share trading increased by 22.7% to a daily average of 3.251bn EUR, compared to 2.649bn EUR in May 2014 (NDAQ) : Co announces May trading stats:

  • Share trading increased by 22.7% to a daily average of 3.251bn EUR, compared to 2.649bn EUR in May 2014. Compared to the previous month, April 2015, the daily average decreased by 16.7 %.
  • Derivatives trading increased by 29.8% to a daily average of 493,804 contracts, compared with 380,509 contracts in May 2014. 
  • ETF trading (Exchange Traded Funds) decreased by 12.4% to a daily average of 49.4m EUR compared to 56.4m EUR in May 2014.

8:59 am Pangea Logistics Solutions announces extension of its Contracts of Affreightment with several global companies, with potential for $22 mln in revenue over 3 years (PANL) :  

8:58 am On the Wires (:WIRES) :

  • Sysmex Corporation and Laboratory Corporation (LH) announced a strategic collaboration focused on the development of blood-based molecular diagnostic tests to advance precision medicine in oncology. Under the terms of this collaboration, Sysmex Inostics will provide reagents and, when appropriate, services to enable Covance's central laboratory to perform OncoBEAM and Plasma Sequencing testing services in its global locations to support oncology clinical trials.
  • Inter Parfums, Inc. (IPAR) announced that its majority owned Paris-based subsidiary, Interparfums SA closed on its Rochas brand acquisition effective May 29, 2015, in accordance with the terms of the agreement with Procter & Gamble Co. dated March 19, 2015. Interparfums completed the acquisition for $108 million, excluding inventory, financed by a 100 million loan repayable over five years, subject to standard covenants.
  • Corning Incorporated (GLW) announced the availability of Corning Lotus NXT Glass, its third-generation glass composition for high- performance displays
  • General Finance Corporation (GFN) announced that Jody Miller has been appointed Executive Vice President of General Finance Corporation and Chief Executive Officer of GFN North America Leasing Corporation
  • Five Below (FIVE) announced the Company will grand open a new distribution center in Oldmans Township, New Jersey. The 1,045,000 square-foot facility, located at 5 Gateway Boulevard, Pedricktown, NJ, will replace the Company's existing 421,000 square foot facility located 12 miles away in New Castle, Delaware
  • EMCORE Corporation (EMKR) announced the appointments of David Wojciechowski as Vice President of Sales and Shane Mortazavi as Vice President of Operations
  • MDU Resources Group (MDU) announced that the Dakota Prairie refinery initiated diesel product sales to the market on May 15. The 20,000 barrels-per-day refinery is the first greenfield fuels refinery built in the U.S. since 1976 and is co-owned and operated with Calumet Specialty Products Partners (CLMT)

8:58 am S&P futures vs fair value: +6.80. Nasdaq futures vs fair value: +20.70. (:WRAPX) : The S&P 500 futures trade seven points above fair value.

It was a relatively mixed showing on Monday from markets in the Asia-Pacific region. China's Shanghai Composite, however, wasted little time in trying to get back on track. It surged 4.7% to begin the week with participants again playing the policy stimulus trade as the HSBC Manufacturing PMI report showed the third straight sub-50 reading. A number below 50 denotes contraction.

  • In economic data: 
    • Japan's Q1 Capital Spending +7.3% year-over-year (expected -0.1%; prior +2.8%) and May Manufacturing PMI 49.2 (expected 49.2; prior 49.1) 
    • China's May HSBC Manufacturing PMI 49.2 (expected 49.2; prior 49.1), May Manufacturing PMI 50.2 (expected 50.2; prior 50.1), and May Non-Manufacturing PMI 53.2 (prior 53.4) 
    • Australia's May AIG Manufacturing Index 52.3 (prior 48.0) and May MI Inflation Gauge +0.3% (prior +0.3%). Separately, Q1 Business Inventories +0.4% month-over-month (expected +0.1%; prior -0.8%), April Building Approvals -4.4% month-over-month (expected -2.0%; prior +2.9%), and April Private House Approvals +4.7% (prior +1.8%) 
    • South Korea's May HSBC Manufacturing PMI 47.8 (expected 49.0; prior 48.8). Separately, May Trade Balance KRW 6.30 bln (expected KRW 6.20 bln; prior KRW 8.50 bln) as May Exports -10.9% year-over-year (expected -9.0%; prior -8.0%) and May Imports -15.3% year-over-year (expected -13.2%; prior -17.8%) 
    • India's May HSBC Markit Manufacturing PMI 52.6 (expected 51.2; prior 51.3) 
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  • Japan's Nikkei eked out a 0.03% gain after trading in negative territory for most of Monday's session. The fractional gain was the twelfth consecutive increase for the Nikkei. The utilities (+1.9%) sector was the best-performing area while the consumer cyclical sector (-0.2%) lagged all others. Individual standouts included Nippon Suisan Kaisha (+4.6%), Teijin Ltd (+3.9%), and Tokyo Electric Power (+3.8%). Yahoo Japan (-3.2%) paced the decliners. Out of the 225 index members, 126 ended higher, 92 finished lower, and 7 were unchanged. 
  • Hong Kong's Hang Seng increased 0.6%, following mainland shares higher. The advance was driven by the financial sector (+1.1%). The consumer cyclical sector (-2.1%) was the only sector to lose ground. Belle Intl. (+5.3%), Bank of Communications (+4.5%), and China Resources Power Holdings (+3.5%) were the best-performing issues. Galaxy Entertainment (-4.5%) and Sands China (-3.7%) led the decliners. Out of the 50 index members, 34 ended higher, 12 finished lower, and 4 were unchanged. 
  • China's Shanghai Composite surged 4.7%. The rebound effort was fueled by renewed thoughts that more policy stimulus may soon be provided. That thinking was helped along by the HSBC Manufacturing PMI report, which at 49.2 was up a tick from March but still the third straight month of contraction. The diversified (+7.2%), utilities (+6.9%), and technology (+6.4%) sectors led the gains in the Chinese market on Monday where every sector gained at least 4.0%. 
Major European indices trade mostly higher with France's CAC (+0.6%) in the lead. There has been no tangible progress with regards to Greece as the May 31 soft deadline passed without an agreement in sight. European indices did surge on a recent rumor that Greece has secured a deal with its creditors, but that rumor has been refuted shortly after surfacing.
  • Participants received several data points: 
    • Eurozone May Manufacturing PMI 52.2 (consensus 52.3; previous 52.3) 
    • Germany's May Manufacturing PMI 51.1 (expected 51.4; prior 51.4) 
    • UK's May Manufacturing PMI 52.0 (expected 52.5; last 51.8) 
    • France's May Manufacturing PMI 49.4 (consensus 49.3; last 49.3) 
    • Italy's May Manufacturing PMI 54.8 (expected 53.6; previous 53.8) 
    • Spain's May Manufacturing PMI 55.8 (consensus 54.8; last 54.2) 
    • Swiss May SVME PMI 49.4 (expected 48.4; prior 47.9) 
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  • UK's FTSE is flat with consumer names in the lead. Compass Group, InterContinental Hotels, and Dixons Carphone are up between 1.7% and 2.0%. Miners lag with Anglo American, Fresnillo, and Glencore down between 1.0% and 1.7% 
  • Germany's DAX has added 0.2% with heavyweights Daimler, SAP, and Siemens contributing to the strength. The three names have gained between 0.8% and 1.0%. Bank shares lag with Deutsche Bank and Commerzbank both down near 0.5%. 
  • In France, the CAC has climbed 0.6% amid broad strength. Consumer and health care names outperform with Sanofi, L'Oreal, Danone, and Accor up between 1.3% and 2.1%. On the downside, Bouygues is the weakest performer, down 0.7%.

8:50 am Enterprise Products announces an agreement to acquire all member interests in EFS Midstream for $2.15 bln, paid in two installments (EPD) : Co announced it has executed definitive agreements to purchase all of the member interests in EFS Midstream from affiliates of Pioneer Natural Resources Company  and Reliance Industries Limited for $2.15 billion.

  •  The purchase price will be paid in two installments with the first installment of $1.15 billion paid at closing and the final installment of $1.0 billion paid no later than the first anniversary of the closing date. EFS Midstream provides gas gathering, treating, compression and condensate processing services in the Eagle Ford Shale. 
  • The EFS Midstream system includes approximately 460 miles of natural gas gathering pipelines, 10 central gathering plants, 780 million cubic feet per day of natural gas treating capacity and 119 thousand barrels per day of condensate stabilization capacity. 
    • Under the terms of the agreements, the Pioneer and Reliance joint development will dedicate its Eagle Ford Shale acreage to Enterprise under a 20-year, fixed-fee gathering agreement that includes a minimum volume requirement for the first seven years. 
    • Pioneer and Reliance will also dedicate their Eagle Ford Shale acreage under related 20-year fee-based agreements with Enterprise for natural gas processing, natural gas liquids transportation and fractionation, and for natural gas, processed condensate and crude oil transportation services.

8:48 am GoPro announces a touch screen display will be available on its HERO+ LCD line of cameras (GPRO) :  

8:48 am MCG Capital says that its Board has determined that the proposal by HC2 Holdings (HCHC) does not constitute, and is not reasonably likely to lead to, a superior proposal under the existing merger agreement with PennantPark Floating Rate Capital (PFLT) (MCGC) : The Board has unanimously affirmed its commitment to the pending merger with PFLT, and its recommendation that MCG stockholders vote in favor of the PFLT transaction. 

8:47 am CA Tech announces appointment of Otto Berkes as Chief Technology Officer, effective June 15, 2015 (CA) : Berkes most recently served as the chief technology officer at HBO

8:46 am Neogen acquires the assets of Sterling Test House, a commercial food testing laboratory based in southwest India; terms not disclosed (NEOG) :  

8:45 am Gapping down (:SCANX) : Gapping down
In reaction to disappointing earnings/guidance
: BAMM -4.8%

Select metals/mining stocks trading lower: GFI -2%, AU -1.9%, MT -1%, BHP -0.9%, RIO -0.8%

Select oil/gas related names showing early weakness: SD -1.6%, STO -1.3%, RDS.A -1.1%, SDRL -0.9%, BP -0.7%

Other news: MCP -24.4% (WSJ details that Molycorp (MCP) is expected to skip its June 1 debt payment), MRTX -20.8% (presented at ASCO, initial data from ongoing expansion study of MGCD265 -- also downgraded to Hold at Brean Capital), CLVS -8.6% (preented at ASCO, Phase 2 studies of rucaparib in ovarian cancer and Rociletinib (CO-1686) Phase 2 study results)

Analyst comments: ACAT -2% (downgraded to Underperform from Market Perform at BMO Capital), GSBD -1.4% (downgraded to Market Perform from Outperform at Wells Fargo), HES -0.8% (downgraded to Hold from Buy at Deutsche Bank)

8:45 am SuperCom reports Q1 in-line; reaffirms guidance (SPCB) : SuperCom Q1 non-GAAP EPS $0.23 vs $0.23 Capital IQ Consensus; revs +45% to $7.7 mln vs $7.60 mln Capital IQ Consensus.

Reaffirms FY15 EPS to exceed $1.20 vs. $1.21 consensus; rev to exceed $41.6 mln vs. $42.9 mln consensus.

8:43 am Gapping up (:SCANX) : Gapping up
In reaction to strong earnings/guidance
: DSKY +12%, GZT +1.4%, NGL +0.6%

M&A news: CLDN +6.1% (co hired Wedbush to seek an acquisition or partnership),ALTR +4.7% (Altera confirms it will be acquired by Intel (INTC) for $54 per share)

Select ASCO presenting names showing strength: ONTY +29.5%, IMGN +19.4%, EXEL +11.4%, VBLT +10.8%, HALO +6.7%, CBLI +5.9%, CTIC +5.2%, RXDX +5.2%, JUNO +4%, OGXI +3.3%, THLD +3.1%, PSTI +2.5%, KPTI +2.2%, BMY +2%, CRIS +1.2%, CLDX +1.1%, CLDX +1.1%

Select China related names showing strength after Shanghai Comp was +4.7% overninght: SFUN +2.2%, LFC +2.1%, YOKU +2%, FXI +1.7%

Other news: PRAN +19% (announces that the EC has approved orphan designation for PBT2 for the treatment of Huntington's disease),HERO +13.7% (received a notice from Saudi Aramco withdrawing the previously issued notice of termination with respect to the contract for the Hercules 261 and declaring that all terms and conditions of the contract remain in full force and effect),CYTX +8.9% (enters into a four year, $17.7 mln term loan with Oxford Finance),MDCO +7.5% (nnounces the results of its Phase 1 study for ABP-700),BIOC +6.1% (announces receipt of a US Patent for its blood collection and transport preservative Diazolidinyl Urea),IMMU +4.7% (reports complete responses in patients with metastatic triple-negative breast cancer after Sacituzumab Govitecan treatment),ADXS +4.3% (announces FDA clearance of investigational new drug application for phase 2 study of ADXS-HPV),CLF +2.8% (still checking; may still be related to Insider purchases rpted on Friday),HRTX +2.7% (discloses it entered into a 7 year Commercial Manufacturing Services Agreement for SUSTOL with Lifecore Biomedical),OREX +2% (discloses it entered into a supply agreement with Mallinckrodt (MNK) for naltrexone),MDXG +1.7% (traded higher AMC Friday, favorable commentary on Friday's Mad Money),NBG +1.5% (cont vol surrounding Greece),ACHN +1.1% (Point72 Asset Management discloses 5.0% passive stake in 13G filing)

Analyst comments: ANR +16.3% (upgraded to Neutral from Sell at Goldman ),LIFE +5.9% (initiated with a Overweight at JP Morgan),SYN +5.3% ( initiated with an Outperform at William Blair; $12 tgt),FATE +3.8% (initiated with a Outperform at Leerink Partners),PAY +2.3% (upgraded to Outperform from Mkt Perform at Raymond James ),BYD +2.2% (upgraded to Outperform from Neutral at Credit Suisse),COLL +1.4% (initiated with a Buy at Jefferies),C +1.1% (upgraded to Buy from Neutral at Goldman)

8:41 am Delta Technology has received approval to list its common shares on the NASDAQ (:DELT) :  

8:37 am Hanwha Q CELLS to change ratio of ADS from 1-5 to 1-50 effective June 15, 2015 (HQCL) : For Hanwha Q CELLS's ADS holders, this ratio change will have the same effect as a one-for-ten reverse ADS split.

8:35 am U.S. Steel announces the completion of its purchase, of AK Steel's (AKS) interest in Double Eagle Steel Coating Company (X) : Items related to the transaction with AK Steel (AKS) include a onetime payment of $25.2 million for the remaining interests of the joint venture as well as the transition of assets and utilities to U. S. Steel Great Lakes Works. Staffing of the facility will remain through AK Steel for a 90-day transition and training period as U. S. Steel determines the appropriate staffing levels.

8:34 am Paragon Offshore announces hiring of Alejandra Veltmann as Chief Accounting Officer (PGN) : Veltmann's most recent role was Vice President and Chief Accounting Officer at Geokinetics, an independent international land and shallow water geophysical services firm

8:34 am European Markets Update: FTSE +0.1%, DAX +0.2%, CAC +0.6% (:SUMRX) : Major European indices hold gains with France's CAC (+0.6%) in the lead. There has been no tangible progress with regards to Greece as the May 31 soft deadline passed without an agreement in sight. European indices did surge on a recent rumor that Greece has secured a deal with its creditors, but that rumor has been refuted shortly after surfacing.

  • Participants received several data points: 
    • Eurozone May Manufacturing PMI 52.2 (consensus 52.3; previous 52.3) 
    • Germany's May Manufacturing PMI 51.1 (expected 51.4; prior 51.4) 
    • UK's May Manufacturing PMI 52.0 (expected 52.5; last 51.8) 
    • France's May Manufacturing PMI 49.4 (consensus 49.3; last 49.3) 
    • Italy's May Manufacturing PMI 54.8 (expected 53.6; previous 53.8) 
    • Spain's May Manufacturing PMI 55.8 (consensus 54.8; last 54.2) 
    • Swiss May SVME PMI 49.4 (expected 48.4; prior 47.9)
------
  • UK's FTSE is higher by 0.1% with consumer names in the lead. Compass Group, InterContinental Hotels, and Dixons Carphone are up between 1.7% and 2.0%. Miners lag with Anglo American, Fresnillo, and Glencore down between 1.0% and 1.7% 
  • Germany's DAX has added 0.2% with heavyweights Daimler, SAP, and Siemens contributing to the strength. The three names have gained between 0.8% and 1.0%. Bank shares lag with Deutsche Bank and Commerzbank both down near 0.5%. 
  • In France, the CAC has climbed 0.6% amid broad strength. Consumer and health care names outperform with Sanofi, L'Oreal, Danone, and Accor up between 1.3% and 2.1%. On the downside, Bouygues is the weakest performer, down 0.7%.

8:33 am OXiGENE announces that the FDA supports phase 3 trial of Fosbretabulin/Bevacizumab combination in platinum-resistant ovarian cancer (OXGN) : Co announces an update on recent discussions with the FDA regarding the design of a proposed Phase 3 trial of fosbretabulin in combination with bevacizumab in patients with platinum-resistant ovarian cancer.

  • FDA agreed with the co's proposal to test the combination anti-vascular regimen of fosbretabulin and bevacizumab directly against chemotherapy using progression-free survival as the primary endpoint in a randomized, controlled registration trial. 
  • FDA requested inclusion of a third arm, of bevacizumab alone, in the trial to further characterize the efficacy of each individual drug in the combination. 
  • OXiGENE intends to submit an application to the FDA for a Special Protocol Assessment later this year

8:33 am NQ Mobile announces the appointment of Roland Wu as CFO, effective June 1, 2015 (NQ) : Wu has served as Executive Director of Winshine Entertainment & Media Holding Co since 2014.

8:32 am Market View: Front-month Jun. stock-index futures hold a decent bid above fair values here following the 8:30 am ET economic data points (:TECHX) :

  • ESm5 @ 2112.00 +6.00

  • YMm5 @ 18084 +75

  • NQm5 @ 4532.75 +21.75

8:32 am Wyndham Worldwide announces it has entered into an agreement with Corinthian Development, to develop 15 new-construction Wingate by Wyndham properties (WYN) : Co announced it has entered into an agreement with Corinthian Development Company to develop more than 15 new-construction Wingate by Wyndham properties in markets throughout the U.S. and Canada over the next two years. Corinthian, along with a strong capital partner with significant experience in hospitality real estate development, plans to deploy up to $250 million of total capital to develop the multiple properties

8:32 am Capstone Turbine announces an order for a 600 KW microturbine system to be installed in the OATI data center and office facility in Bloomington, Minnesota (CPST) :

  • Co announced that it received an order for a 600-kilowatt microturbine system to be installed in the OATI data center and office facility currently under construction in Bloomington, Minnesota.
  • The C600 package will provide the new OATI South Campus facility with electricity, hot water and chilled water 24/7/365. Because of the critical nature of the complex, the microturbine will be configured to provide power in stand-alone mode in the event of a grid failure.
  • The C600 will operate in parallel with wind, solar, and energy storage systems at the facility, along with the utility grid network.

8:32 am Uni-Pixel appoints Jalil Shaikh as COO (UNXL) : Shaikh most recently served as VP and GM of Atmel (ATML) where he launched the touch materials business unit focused on capacitive touch sensor technology using copper, designed as a superior alternative to ITO-based sensors.

8:31 am Castlight Health announces selection by the Union Pacific Railroad Employes Health System, to manage union member benefits through its Castlight Enterprise Healthcare Cloud platform (CSLT) :  

8:31 am Merck and Dynavax Technologies (DVAX) announce they have entered into two clinical trial collaboration agreements to investigate the potential synergistic effect of combining immunotherapies from both companies' pipelines (MRK) :

  • MRK, known as MSD outside the United States and Canada, and Dynavax Technologies (DVAX) announced they have entered into two clinical trial collaboration agreements to investigate the potential synergistic effect of combining immunotherapies from both companies' pipelines: Merck's anti-PD-1 therapy, KEYTRUDA (pembrolizumab), and its investigational anti-interleukin-10 (anti-IL-10) immunomodulator, MK-1966, with Dynavax's investigational toll-like receptor 9 (TLR9) agonist, SD-101.
  • Under the terms of the agreement, Dynavax will sponsor and fund the SD-101 and KEYTRUDA study. Merck will sponsor and fund the SD-101 and MK-1966 study.
  • The agreements include provisions where the parties may agree to extend either collaboration to include a Phase 3 clinical trial. Additional details of the agreements between Dynavax and Merck, through a subsidiary, were not disclosed.

8:31 am S&P futures vs fair value: +7.70. Nasdaq futures vs fair value: +22.70. (:WRAPX) : The S&P 500 futures trade eight points above fair value.

April personal income rose 0.4% while the Briefing.com consensus expected an uptick of 0.3%. Meanwhile, personal spending was unchanged while the consensus expected an increase of 0.2%.

Core PCE prices rose 0.1% while the Briefing.com consensus expected a reading of 0.2%.

8:31 am Altera confirms it will be acquired by Intel (INTC) for $54 per share in an all-cash transaction valued at ~$16.7 bln (shares halted) (ALTR) : Intel (INTC) confirmed it would acquire Altera for $54 per share in an all-cash transaction valued at approximately $16.7 billion.

  • Altera will become an Intel business unit to facilitate continuity of existing and new customer sales and support. Intel plans to continue support and development for Altera's ARM-based and power management product lines. 
  • The transaction is expected to be accretive to Intel's non-GAAP EPS and free cash flow in the first year after close. Intel intends to fund the acquisition, which is expected to close within six to nine months, with a combination of cash from the balance sheet and debt.

8:31 am Peregrine Pharma provides update on planned expansion of Bavituximab clinical program; includes the Phase II trial to evaluate combination of Bavituximab and Opdivo (Nivolumab) in non-small cell lung cancer (PPHM) : Co provided a corporate update on its immuno-oncology pipeline, its wholly-owned contract manufacturing business, Avid Bioservices, as well as anticipated upcoming milestones. 

  • The company's Phase III SUNRISE (Stimulating ImmUne RespoNse thRough BavItuximab in a PhaSE III Lung Cancer Study) is an approximately 600 patient trial that continues to enroll at over 150 sites worldwide. Completion of enrollment is anticipated by calendar year-end. This Phase III, randomized, double-blind, placebo-controlled clinical trial is designed to evaluate the safety, tolerability and efficacy of bavituximab as a second-line treatment in patients with non-squamous, non-small cell lung cancer (:NSCLC).
  • The company plans to initiate an open-label multi-center, randomized Phase II trial of the anti-PD-1 monoclonal antibody nivolumab (marketed as Opdivo) versus nivolumab plus bavituximab in patients with previously treated locally advanced or metastatic NSCLC. Enrollment will include patients with squamous and non-squamous NSCLC who have not received a prior PD-L1 or PD-1 inhibitor. The primary endpoint of this trial will be overall response rate (ORR.V) with secondary endpoints including tumor response and duration, progression free survival, overall survival (:OS) and safety. The trial is in the final stages of design and the details of which will be made available once details are completed. Trial initiation is anticipated in the second half of 2015.
  • The company plans to initiate a Phase II/III open-label trial of physician's choice of either docetaxel or paclitaxel with or without bavituximab in patients with locally advanced or metastatic HER2 negative breast cancer. The primary endpoint for the Phase II trial will be ORR. Results from this trial are expected to inform decisions on future studies in breast cancer and add value to the overall program. The initiation of this trial is anticipated in the second half of 2015.

8:31 am Teva Pharma announces the launch of the generic equivalent to Actonel Tablets, 5 mg, 30 mg, and 35 mg, in the US (TEVA) :  

8:30 am Wheeler Real Estate Investment Trust secures $45 million credit facility with KeyBank (WHLR) :

  • Co announced that it has secured a $45 mln revolving credit facility with KeyBank National Association. The Company expects primarily to use the facility to acquire select grocery-anchored properties located in its targeted secondary and tertiary markets throughout the Northeast, Mid-Atlantic, Southeast, and Southwest regions of the United States.
  • The new facility will replace the Company's previous $25 mln secured guidance credit facility with KeyBank which was set to expire Dec 31, 2015. The revolver, led by KeyBanc Capital Markets as Arranger, will initially provide the ability to borrow up to $45 mln, with KeyBank National Association providing the full commitment. The facility includes a provision that under certain conditions allows for expansion of the facility to a maximum of $100 mln through syndication with other lenders.

8:28 am On the Wires (:WIRES) :

  • Rockwell Medical (RMTI) announced that the Centers for Medicare and Medicaid Services has granted a unique product reimbursement code for Triferic
  • Seabridge Gold (SA) reports that core drilling has started at its 100%-owned KSM Project in northwestern British Columbia. This year's main goal is to determine the potential for a high-grade core zone beneath the known Mitchell deposit, which is KSM's largest. The program will also seek to enlarge and refine the block cave mining potential for Deep Kerr and the Iron Cap Lower Zone.
  • Resolute Forest Products Inc. (RFP) announced a major decision to build a facility to manufacture at-home, premium private label tissue paper, including bath and towel. Resolute's tissue paper machine and converting operations will be built at the Calhoun mill in Tennessee. The $270 million project represents the largest investment made by Resolute since 2010. At full capacity, the new tissue and converting facilities will produce a~60,000 metric tons per year of at-home, premium bath tissue and towel.
  • Materialise NV (MTLS) announced that Consensus Orthopedics will use its Knee Guide System.
  • Raven Industries (RAVN) has been awarded a firm-fixed price contract through the Naval Air Warfare Center Aircraft Division for the procurement of Exportable Persistent Ground Surveillance Systems (:EPGSS), spare equipment and technical support. The tethered aerostat contract was awarded for approximately $6 million and is expected to be delivered over the next 12 months.
  • IPC Healthcare, Inc. (IPCM) announced that it has appointed Ron Greeno, M.D., FCCP, MHM to the newly created position of Chief Strategy Officer, where he will be responsible for leading the company's strategic initiatives

8:26 am European Yields (BONDX) : Core Unchanged, Periphery Declines

  • The sovereign debt of Germany and France found better buying interest today with the Manufacturing PMI's of those nations continuing to show weakness. Meanwhile, the Italian and Spanish manufacturing sectors are showing substantial strength. Greece tensions have not eased over the weekend, although a rumor about a deal this morning has erased German Bund gains despite the rumor being denied by officials
  • Yield Check:
    • France, 10-yr OAT:unch at 0.80%
    • Germany, 10-yr Bund: unch at 0.48%
    • Greece, 10-yr note: +15 bps to 11.22%
    • Italy, 10-yr BTP: +4 bps to 1.90%
    • Portugal, 10-yr note: +12 bps to 2.67%
    • Spain, 10-yr Bono: +4 bps to 1.88%
    • U.K., 10-yr Gilt: +1 bp to 1.84%

8:09 am Kratos Defense and Security to sell U.S. and U.K. operations of electronic products division for $265 mln (KTOS) :

  • Under the terms of the Agreement, Kratos will be making a 338(h)(10) election for income tax purposes, providing a "step up" in tax basis and certain other related future tax attributes to Ultra. As a result of the Transaction, Kratos will be utilizing approximately $180 mln of its total aggregate approximate $400 mln in income tax net operating loss (NOL.V) carryforwards, reducing the total taxable gain of the Transaction to Kratos. Total Transaction related costs and net cash taxes to be paid are estimated to aggregate ~$25 mln, resulting in total initial estimated net cash proceeds from the Transaction to Kratos of ~$240 mln. Post Transaction close, Kratos will have over $200 mln in NOL's and over $110 mln in additional income tax related deductions available to reduce future taxable income. 
  • Following the closing of the Transaction, Kratos currently intends to initiate a repurchase process for ~$175 to $200 mln of 7% Senior Secured Notes at par, once all requisite requirements have been met in accordance with the Notes Indenture Agreement. In addition, Kratos intends to pay down all outstanding amounts on the Company's $110 mln bank credit facility, which total ~$41 mln. In connection with the Transaction, the Company also amended its credit facility to allow for this divestiture as well as provide a permanent reduction in the financial covenants for future periods under the credit agreement.

8:07 am Momenta Pharma to present new data from Phase 1 Trial of necuparanib in patients with pancreatic cancer; results show that adding necuparanib to GEM or nabP + GEM did not appear to increase the incidence, severity, or duration of the expected AEs associated with these regimens (MNTA) :

  • Co will present updated data from the Phase 1 trial evaluating necuparanib in combination with nab-paclitaxel (nabP; Abraxane) and gemcitabine (:GEM) in patients with advanced metastatic pancreatic cancer (ClinicalTrials.gov Identifier NCT01621243) at the 2015 ASCO Annual Meeting, today from 8:00 to 11:30 am CDT (Abstract #4114).
  • Necuparanib was administered daily in combination with 125 mg/m2 nabP and 1000 mg/m2 GEM (Days 1, 8, and 15 of each 28-day cycle). The necuparanib starting dose was 0.5 mg/kg, which was increased via a modified 3+3 design until a maximum tolerated dose (MTD) was determined. nabP was added to the treatment regimen starting with Cohort 3. Thirty-nine patients (12 patients in the first two cohorts and 27 patients in the five subsequent cohorts) received necuparanib and were included in the analyses. Top-line results included:
    • Adding necuparanib to GEM or nabP + GEM did not appear to increase the incidence, severity, or duration of the expected AEs associated with these regimens
    • 5 mg/kg necuparanib was determined to be the MTD and the recommended Phase 2 dose.
    • Encouraging signals of activity were observed:
      • For the 24 patients in cohorts 3-7 who received at least one dose of necuparanib + nabP + GEM, the median overall survival (:OS) was 14.2 (95% CI, 9.3-16.0) months
      • Sixteen patients were treated with necuparanib + nabP + GEM, completed Cycle 1, and had =1 scan on treatment; of these, eight (50%) achieved RECIST partial response (:PR) and six (38%) more achieved stable disease (SD), for a disease control rate (PR+SD) of 14/16 (88%). Median OS was 15.3 (95% CI, 9.7-16.0) months in this subset.
      • Fifteen patients were treated with necuparanib + nabP + GEM, completed Cycle 1, and had =1 follow-up CA19.9 measurement; of these, 15 (100%) had >20%, 14 (93%) had >50%, and seven (47%) had >90% decreases from baseline (CA19.9 is a biomarker predictive for long-term outcome and treatment response in pancreatic cancer).

8:07 am TransEnterix submits 510(k) application to FDA for SurgiBot system (TRXC) : Co announced the submission of its 510(k) application with the U.S. Food and Drug Administration (:FDA) for clearance of the company's SurgiBot System. The SurgiBot System is the first patient-side, robotically enhanced laparoscopy platform.

8:07 am OGE Energy CEO steps down; to become interim CEO at Enable Midstream (ENBL); President Sean Trauschke named CEO (OGE) : OGE Energy Chairman and CEO Pete Delaney announce that he has stepped down from the CEO position to become the interim CEO of Enable Midstream (ENBL) in Oklahoma City. The OGE Energy Board of Directors has named OGE Energy President Sean Trauschke CEO. Enable Midstream is a Master Limited Partnership in which OGE Energy has a significant interest. Delaney will continue to serve as Chairman of the Board of OGE Energy until next year as planned.

8:07 am OM Group agrees to be acquired by Apollo Affiliated Funds in partnership with Platform Specialty Products Corporation for $34.00 per share in an all cash transaction (OMG) : Co announces that it has entered into a definitive agreement to be acquired by funds managed by affiliates of Apollo Global Management (APO) for $34.00 per share in cash. The purchase price represents a premium of approximately 28% over OMG's closing share price on May 29, 2015.

  • Platform Specialty Products (PAH) will acquire OMG's Electronic Chemicals and Photomasks businesses, which combined represented approximately $28 million of adjusted EBITDA in 2014, from the Apollo Funds in two separate transactions for total cash consideration of $365 million.

    Platform believes there is a synergy opportunity in excess of $20 million over the next two years from the combination of these complementary assets. Following the transactions, the Apollo Funds will own OMG's Magnetic Technologies, Battery Technologies and Advanced Organics businesses.

  • The Boards of Directors of OMG and Platform unanimously approved the respective transactions. The acquisition of OMG is expected to be completed by the end of 2015.

8:06 am ZAIS Financial elects Donna J. Blank as Chief Financial Officer and Treasurer effective today (ZFC) : Co announced that its Board of Directors has elected Donna J. Blank as the Chief Financial Officer and Treasurer effective today. Ms. Blank replaces Paul McDade, who has assumed the position of Managing Director for Special Projects within ZAIS Group, LLC primarily related to new business activities. The Company is externally managed by a subsidiary of ZAIS Group, LLC.

8:06 am Corbus Pharma announces presentation of positive data on Resunab in pre-clinical models of cystic fibrosis, indicating survival, decreased weight loss in tested mice (CRBP) : The results of the study indicate that in CFTR-deficient mice infected with Pseudomonas aeruginosa, Resunab improved survival, decreased weight loss, reduced the numbers of neutrophils and white blood cells in the lung and improved the ability of animals to resolve pulmonary infection as assessed by lung bacterial colony forming units, compared to control treatment. The study suggests that Resunab could potentially be effective in addressing inflammation in cystic fibrosis patients, and furthermore improve the body's ability to resolve pulmonary bacterial infection.

  • Co stated: "Data showing that Resunab improved overall health in CFTR-deficient mice and reduced bacterial bioburden is encouraging as we prepare to commence our CF Phase 2 clinical study over the next 90 days."

8:05 am Rockwell Medical announces that the Centers for Medicare and Medicaid Services has granted a unique product reimbursement code for Triferic (RMTI) : The Centers for Medicare and Medicaid Services (CMS) has granted a unique product reimbursement code for Triferic. The Level II Healthcare Common Procedure Coding System (:HCPCS) product reimbursement Q-code (Q9976) will help facilitate the billing process for dialysis organizations using Triferic. This new Q-code will become effective on July 1, 2015. Triferic is the only iron product that is FDA approved for delivery via dialysate to replace iron and maintain hemoglobin to treat anemia in the hemodialysis patient population in the United States.

8:05 am Genomic Health announces results from multiple Oncotype DX studies; new data includes two positive studies in DCIS breast cancer and report of baseline characteristics in NCI's TAILORx Trial (GHDX) :

  • A secondary analysis from the second large validation study evaluated the DCIS Score result as a predictor of local recurrence in 718 patients treated with breast-conserving surgery alone with any surgical margin width. The analysis showed that, in all patients regardless of margin status, the DCIS Score result was significantly associated with the 10-year risk of local recurrence.
  • A separate secondary analysis evaluated the correlation between the DCIS Score result and clinicopathologic features, such as age, tumor size, nuclear grade and multifocality. The results from 571 women with DCIS who had BCS alone and clear margins showed that the DCIS Score result quantifies risk of local recurrence independent of clinicopathologic features, reconfirming previous findings from the ECOG-ACRIN Cancer Research Group clinical validation study.
  • In prostate cancer, a study of 3,500 patient tumor samples processed in GHDX's commercial laboratory highlighted the importance of utilizing multiple biological pathways to predict tumor behavior. In this study, each of the four gene groups incorporated in the Oncotype DX Genomic Prostate Score showed large variations in expression and meaningfully affected the GPS results, underscoring the importance of analyzing distinct genes across multiple pathways to provide more accurate risk assessment than currently available clinical risk factors and help improve treatment decision making.

8:04 am Celsion presents GEN-1 immunotherapy Phase 1b results in recurrent ovarian cancer at ASCO 2015; significant clinical benefit observed at highest dose (CLSN) :

  • Co announced the presentation of clinical results from its Phase IB trial for GEN-1 in platinum-resistant ovarian cancer in a poster session by Dr. Premal H. Thaker, M.D., associate professor at Washington University and Siteman Cancer Center in St. Louis, on Saturday, May 30th at the 2015 American Society of Clinical Oncology (TATD) Meeting in Chicago. GEN-1 is an IL-12 DNA plasmid vector encased in a nanoparticle delivery system, which enables cell transfection followed by persistent, local secretion of the IL-12 protein.
  • The Phase 1B dose escalating study enrolled 16 patients with platinum-resistant ovarian cancer and evaluated the safety, tolerability and efficacy of GEN-1 in combination with pegylated doxorubicin as well as the effect of intraperitoneal injection of GEN-1 on IL-12 and tumor cytokine levels. Patients received pegylated liposomal doxorubicin on day 1 and GEN-1 on days 1, 8, 15 and 22. This treatment regimen was repeated every 28 days in the absence of disease progression or toxicity.
  • The clinical findings demonstrated an overall clinical benefit of 57% for all treatment arms, with a partial response (:PR) rate of 21% and a stable disease (SD) rate of 36%. The overall clinical benefit observed at the highest dose cohort in this difficult-to-treat patient population was 100% (PR=33% and SD=67%) in all six evaluable patients. GEN-1 was well tolerated, with no dose limiting toxicities and no overlapping toxicities between GEN-1 and pegylated doxorubicin.

8:04 am Intl Game Tech. PLC announced the signing of an agreement with the Massachusetts Gaming Commission, for a new central monitoring system, for $23 mln over 10 years (IGT) :  

8:04 am AbbVie reports findings from a Phase 2 study of veliparib combined with the chemotherapy regimen carboplatin and paclitaxel showing an improvement in median progression-free survival (ABBV) : Co announced findings from a Phase 2 study of the investigational medicine veliparib combined with the chemotherapy regimen carboplatin and paclitaxel that showed an improvement in median progression-free survival (PFS) in patients with previously untreated metastatic or advanced non-small cell lung cancer (:NSCLC) who are current smokers.

  • These data will be presented at the American Society of Clinical Oncology (TATD) Annual Meeting on June 1 in Chicago. 
  • A Phase 3 study has been initiated in NSCLC patients with smoking history based on the results seen in the Phase 2 study. 

8:03 am Unisys Names Tarek El-Sadany as SVP of Technology and Chief Technology Officer (UIS) : El-Sadany was most recently vice president of Global Product Support Services for Oracle Corporation (ORCL)

8:03 am Onconova Therapeutics presents clinical data on Rigosertib in higher-risk Myelodysplastic syndromes at the 2015 ASCO Annual Meeting (ONTX) : A subgroup analysis of the ONTIME trial revealed a significant survival advantage for patients in the revised International Prognostic Scoring System Very High Risk category. Among the 134 patients who were in the IPSS-R Very High Risk category, median overall survival was 7.6 months in the rigosertib arm compared to 3.2 months in the best supportive care arm, with a hazard ratio of 0.56. Baseline characteristics among IPSS-R Very High Risk patients, including primary HMA failure, FAB classification, ECOG performance status, bone marrow blast percentage, hemoglobin levels, platelet count and neutrophil count also correlated with better survival with IV rigosertib.

8:03 am Merck announces the first-time presentation of findings investigating the use of KEYTRUDA; registrational studies for KEYTRUDA ongoing in eight different tumor types (MRK) :

  • Merck, known as MSD outside the United States and Canada, announced the first-time presentation of findings investigating the use of KEYTRUDA (pembrolizumab), the company's anti-PD-1 therapy, in multiple, difficult-to-treat cancers, including advanced small cell lung cancer (:SCLC), esophageal cancer and ovarian cancer from the KEYNOTE-028 Phase 1b study.
  • These data, which were presented at the 51st Annual Meeting of the American Society of Clinical Oncology (TATD) in Chicago, May 29 -- June 2, 2015, build upon Merck's broad and fast-growing immuno-oncology clinical development program for KEYTRUDA.

8:03 am BlackBerry and Typo agree to settlement; Typo agrees to permanently discontinue selling anywhere in the world keyboards for smartphones and mobile devices with a screen size of less than 7.9" (BBRY) : BlackBerry and Typo Products LLC, Typo Innovations LLC, Show Media LLC, Hallier Investments LLC, and Laurence Hallier have settled their outstanding legal disputes.

  • As part of the settlement, Typo Products LLC, Typo Innovations LLC, Show Media LLC, Hallier Investments LLC, and Laurence Hallier have agreed to permanently discontinue selling anywhere in the world keyboards for smartphones and mobile devices with a screen size of less than 7.9 inches. Typo Products LLC, Typo Innovations LLC, Show Media LLC, Hallier Investments LLC, and Laurence Hallier may continue to sell keyboards for devices with a screen size of 7.9 inches or larger. Other terms of the settlement are confidential.

8:03 am Integrated Silicon responds to increased non-binding offer from Cypress (CY); continues to expect to close the transaction with Uphill in the third calendar quarter of 2015 (ISSI) :

  • After reviewing the revised Cypress offer (including the Cypress comments to the merger agreement draft provided by ISSI on May 21, 2015) with its financial and legal advisors, ISSI remains concerned about the ability of Cypress to finance the approximately $680 million purchase price with only approximately $157 million in cash and cash equivalents and ~$494 million in debt on its balance sheet at March 31, 2015. ISSI has previously asked Cypress to provide it with a financing commitment letter to support the proposed purchase price. However, Cypress has not provided such letter. This letter is necessary for due diligence purposes so that ISSI can have customary assurances that the purchase price can be paid by Cypress.
  • ISSI is also concerned with the ability of a transaction with Cypress to obtain antitrust clearance in the U.S. and Germany and the timing of such clearance. As such, ISSI believes that there is significant risk that the antitrust review by the FTC or DOJ could take up to nine months, which would delay the closing of a transaction between Cypress and ISSI into 2016, and that there is a high possibility that the acquisition of ISSI by Cypress would not be approved by the FTC or DOJ without a divestiture of some or all of ISSI's SRAM business which represents up to ~25% of ISSI's revenue. 
  • As originally announced on March 12, 2015, ISSI continues to expect to close the transaction with Uphill in the third calendar quarter of 2015. In an effort to maximize stockholder value, ISSI has cooperated fully with Cypress and permitted Cypress to conduct extensive due diligence in accordance with the terms of the binding Uphill Agreement. A confidentiality agreement with Cypress was signed on May 19, 2015, just three business days after Cypress submitted their first non-binding offer, and Cypress was provided access to an electronic data room the next morning.
  • The ISSI special meeting of stockholders to consider approval of the transaction with Uphill and related matters is scheduled for June 12, 2015 at 2:00 p.m. local time.

8:02 am Jason Industries acquires DRONCO GmbH; JASN raises FY15 guidance following acquisition (JASN) :

  • JASN announces the acquisition of European abrasives manufacturer DRONCO GmbH, for approximately 32 million in cash and 10 million of assumed liabilities. 
  • Co raises FY15 outlook to incorporate the acquisition of DRONCO. Now expects 2015 sales of $708-723 mln, up from $685-700 mln prior guidance (not comparable to current Capital IQ Consensus of $688.8 mln). Now expects Adjusted EBITDA in the range of $87 to $91 million, up from $84 to $88 million prior guidance.

8:02 am Juno announces its Investigational CAR T Cell product candidate JCAR014 demonstrates encouraging clinical responses (JUNO) :

  • Co announced that clinical data from a chimeric antigen receptor (CAR) T cell product candidate, JCAR014, demonstrated encouraging clinical responses in patients with B-cell cancers.
  • In an oral presentation on Monday, June 1, 2015 by Cameron J. Turtle, MBBS, Ph.D. of the Fred Hutchinson Cancer Research Center entitled, "Immunotherapy with CD19-specific chimeric antigen receptor (CAR)-modified T cells of defined subset composition" updated Phase I results in a total of 52 patients treated with JCAR014 against B-cell malignancies will be reported from this ongoing trial: 
  • CD19 CAR T cells of defined subset composition demonstrated potent anti-tumor activity: CR as documented by flow cytometry was observed in 21/23 (91%) of evaluable patients with relapsed or refractory (r/r) B-cell ALL; complete or partial responses were observed in 12/19 (63%) of patients with r/r NHL; and complete responses were obtained in 2/5 patients with r/r chronic lymphocytic leukemia. JCAR014 is in an ongoing Phase I/II trial in patients with r/r B cell malignancies, including ALL, NHL and CLL.
  • Juno intends to continue enrolling patients in this trial through 2015 in order to gain insights into various factors that may improve the expansion and persistence of these CAR T cells in the body.

8:02 am KBR announces the award of a near-shore floating LNG Front End Engineering Design contract by Lloyds Energy (KBR) : Co has been awarded a near-shore floating LNG Front End Engineering Design (FEEDQ) contract by Lloyds Energy Ltd. Under this contract, KBR will provide integrated topsides and hull engineering design services for a nominal 2.5 million TPA floating natural gas liquefaction plant (:FLNG). Start-up of the project facilities is expected to take place in 2019.

8:02 am Enable Midstream Partners announces Lynn Bourdon has submitted his resignation, andstepped down from his positions as president and CEO (ENBL) : The board of directors of Enable Midstream's general partner, Enable GP, LLC, named Scott Prochazka as chairman of Enable GP's board and appointed board member Pete Delaney as interim president and CEO, effective immediately. A special committee of the board will conduct the search for a permanent CEO of Enable Midstream with the assistance of executive search firm Russell Reynolds.

8:01 am Ferrellgas Partners announces the acquisition of integrated crude oil midstream services firm Bridger Logistics for $837.5 mln, along with a dividend increase to $0.5125/share (FGP) : Co announces it has entered into a definitive purchase and sale agreement to acquire Dallas-based Bridger Logistics, a provider of integrated crude oil midstream services, for a purchase price of ~$837.5 mln, subject to certain closing adjustments.

  • Co also announces a $0.0125 increase in its quarterly distribution rate to $0.5125 per FGP common unit ($2.05 on an annualized basis), effective following the closing of the transaction.

8:01 am JPS Industries: Handy & Harman Ltd. enters into definitive agreement to acquire JPS Industries, Inc.; stockholders of JPS will receive $11.00 per share in cash (JPST) : Handy & Harman (HNH) and JPS Industries (JPST) announced that they have entered into a definitive merger agreement pursuant to which HNH will acquire JPS. Under the terms of the merger agreement, which has been unanimously approved by the Boards of Directors of both HNH and JPS, all stockholders of JPS will receive $11.00 per share in cash for each share of JPS they own

  • The acquisition of JPS will be effected by HNH's wholly owned subsidiary, Handy & Harman Group Ltd. ("HNH Group"), through one of HNH Group's subsidiaries, HNH Group Acquisition LLC. Following the consummation of the merger, pursuant to a separate agreement between HNH Group and SPH Group Holdings (SPLP), the parent company of HNH. 
  • SPHG Holdings will exchange its shares of JPS common stock for shares of common stock of HNH, based on an $11.00 per share valuation for the JPS shares, so that HNH Group will own 100% of the shares of JPS.
  • In addition, under the terms of the merger agreement, JPS has a "go-shop" for a period of 30 days following May 31, 2015 pursuant to which it is permitted to solicit, initiate, encourage and facilitate any alternative transaction proposals from third parties and to participate in negotiations with third parties regarding any alternative transaction proposals.
  • HNH Group Acquisition LLC has terminated its previously announced tender offer for approximately 96.5% of the outstanding shares of common stock of JPS in accordance with the terms of its offer to purchase.

8:01 am Cytori Therapeutics enters into a four year, $17.7 mln term loan with Oxford Finance (CYTX) : Co entered into a four year, $17.7 million term loan with Oxford Finance. The loan provides for an interest-only payment period of at least 12-months with the potential to be extended up to 18-months. Proceeds were used to prepay Cytori's existing loan with Oxford Finance and Silicon Valley Bank. 

8:01 am Hersha Hospitality Trust announces 1-for-4 reverse share split; effective June 22, 2015 (HT) : "Hersha's 1-for-4 reverse share split, implying an annualized dividend of $1.12, will allow Hersha to target a broader group of domestic and international institutional investors and brings our stock price in-line with our lodging REIT peers, the majority of which came to market at prices between $17-to-$22 per share at the time of their IPO. The reverse share split also affords our institutional investors reduced trading costs and results in reduced administrative costs for the Company."

7:58 am On the Wires (:WIRES) :

  • WEX Inc. (WEX) announced that it has entered into an over-the-road fuel card program through which WEX Bank will offer customers of GE Capital, Transportation Finance co-branded over-the-road fuel card services.
  • Agilysys, Inc. (AGYS) announced that Robert Jacks has been named vice president of professional services for the company, effective June 1

7:57 am WTI crude oil futures begin the morning off lower; July crude is now -0.9% at $59.79/barrel (:COMDX) :  

7:54 am S&P futures vs fair value: +9.40. Nasdaq futures vs fair value: +23.80. (:WRAPX) : U.S. equity futures hover near their pre-market highs following a recent spike that followed rumors suggesting a deal between Greece and its creditors will be announced today. However, it is worth noting that similar reports have circulated in recent days and there has been no official confirmation as of yet. The S&P 500 futures hover nine points above fair value after spiking over the past 30 minutes.

Meanwhile, Treasuries hold modest losses with the 10-yr yield higher by two basis points at 2.14%.

Personal Income (Briefing.com consensus 0.3%)/Spending (consensus 0.2%) data for April and Core PCE Prices (expected 0.2%) will be released at 8:30 ET while April Construction Spending (consensus 0.8%) and the May ISM Index (consensus 51.9) will both be reported at 10:00 ET.

In U.S. corporate news of note:

  • Altera (ALTR 51.70, +2.85): +5.8% after the Wall Street Journal reported the company has agreed to be acquired by Intel (INTC 34.69, +0.23). 
  • Citigroup (C 54.85, +0.77): +1.4% after Goldman Sachs upgraded the stock to 'Buy' from 'Neutral.'
Reviewing overnight developments:
  • Asian markets ended mostly higher. China's Shanghai Composite +4.7%, Hong Kong's Hang Seng +0.6%, and Japan's Nikkei ended flat. 
    • In economic data: 
      • Japan's Q1 Capital Spending +7.3% year-over-year (expected -0.1%; prior +2.8%) and May Manufacturing PMI 49.2 (expected 49.2; prior 49.1) 
      • China's May HSBC Manufacturing PMI 49.2 (expected 49.2; prior 49.1), May Manufacturing PMI 50.2 (expected 50.2; prior 50.1), and May Non-Manufacturing PMI 53.2 (prior 53.4) 
      • Australia's May AIG Manufacturing Index 52.3 (prior 48.0) and May MI Inflation Gauge +0.3% (prior +0.3%). Separately, Q1 Business Inventories +0.4% month-over-month (expected +0.1%; prior -0.8%), April Building Approvals -4.4% month-over-month (expected -2.0%; prior +2.9%), and April Private House Approvals +4.7% (prior +1.8%) 
      • South Korea's May HSBC Manufacturing PMI 47.8 (expected 49.0; prior 48.8). Separately, May Trade Balance KRW 6.30 bln (expected KRW 6.20 bln; prior KRW 8.50 bln) as May Exports -10.9% year-over-year (expected -9.0%; prior -8.0%) and May Imports -15.3% year-over-year (expected -13.2%; prior -17.8%) 
      • India's May HSBC Markit Manufacturing PMI 52.6 (expected 51.2; prior 51.3) 
    • In news: 
      • Lukewarm PMI readings in China stoked expectations for more easing from the People's Bank of China, leading to a rally in the Shanghai Composite
  • Major European indices hold gains. France's CAC +0.8%, Germany's DAX +0.6%, and UK's FTSE +0.2%. Elsewhere, Italy's MIB +0.5% and Spain's IBEX +0.8%. 
    • Participants received several data points: 
      • Eurozone May Manufacturing PMI 52.2 (consensus 52.3; previous 52.3) 
      • Germany's May Manufacturing PMI 51.1 (expected 51.4; prior 51.4) 
      • UK's May Manufacturing PMI 52.0 (expected 52.5; last 51.8) 
      • France's May Manufacturing PMI 49.4 (consensus 49.3; last 49.3) 
      • Italy's May Manufacturing PMI 54.8 (expected 53.6; previous 53.8) 
      • Spain's May Manufacturing PMI 55.8 (consensus 54.8; last 54.2) 
      • Swiss May SVME PMI 49.4 (expected 48.4; prior 47.9) 
    • Among news of note: 
      • European indices surged on the speculation that Greece has secured a deal with its creditors, but there has been no official confirmation yet. It is worth noting the country is scheduled to make four payments totaling EUR1.60 billion to the International Monetary Fund this month, with the first one due Friday

7:45 am Bristol-Myers announces acceptance by the US FDA, of the supplemental Biologics License Application for Opdivo +Yervoy regimen, in patients with previously untreated advanced melanoma (BMY) : The projected FDA action date is September 30, 2015

7:41 am XPO Logistics announced that it intends to issue $2 bln of senior notes (XPO) : XPO intends to use the net proceeds from the offering, together with cash on hand and the proceeds from its separately announced private placement of $1.26 billion of equity securities, to finance the purchase of Norbert Dentressangle SA and Bridge Terminal Transport Services, Inc., to repay certain existing indebtedness of Norbert Dentressangle SA and its subsidiaries, for other unspecified acquisitions, to pay related fees and expenses, and/or for working capital and other general corporate purposes.

7:39 am Overnight Treasury Summary (BONDX) : Treasuries Slip Slightly

  • The U.S. Treasury complex pulled back this morning as global equities edged up and Chinese stocks recovered much of last Thursday's losses
  • Yield Check:
    • 2-yr: +1 bp to 0.62%
    • 5-yr: +1 bp to 1.49%
    • 10-yr: unch at 2.13%
    • 30-yr: unch at 2.89%
  • International News:
    • China's HSBC Manufacturing PMI for May met expectations at 49.2, up from 49.1 in April
      • The mediocre data and resulting rumors of further stimulus from the Chinese government sent the Shanghai Composite up 4.71% to 4,828.74
    • There was talk of a doubling in the size of the government's bond swap program, whereby local-government loans are swapped into municipal bonds
    • The Markit Puchasing Managers Index for the eurozone increased to 52.2 in May from 52 in April. The preliminary reading was 52.3
      • The Spanish manufacturing PMI leapt to 55.8 in May from 54.2 in April. The reading reflects the fastest rate of expansion since 2007
      • The Italian manufacturing PMI hit a 4-year high in May at 54.8, up from 53.8 in April
    • Performances in the European core were not as strong, with France's factory sector still contracting and Germany's growth slowing more than expected
    • Deposits in Greek banks touched an 11-year low in April, increasing the fragility of the banking system
      • German Chancellor Angela Merkel, French President Francois Hollande, and European Commission Presdient Jean-Claude Juncker are in Berlin today to discuss Greece and British membership in the eurozone
      • Greece's IMF representative candidate is withdrawing amidst criticism from members of Syriza that she supported the previous bailout program
  • Data out Today:
    • April Personal Income and Personal Spending (08:30 ET)
    • April PCE Prices -- Core (08:30 ET)
    • May ISM Index (10:00 ET)
    • April Construction Spending (10:00 ET)
  • Fed Speaker:
    • Boston Fed President Rosengren speaks before the 2015 Workforce Stars Breakfast (09:05 ET)

7:34 am Advaxis announces FDA clearance of investigational new drug application for phase 2 study of ADXS-HPV and Incyte's epacadostat for the treatment of HPV-associated early stage cervical cancer (ADXS) :

  • Co announced the clearance of the Investigational New Drug (IND) application by the United States Food and Drug Administration (:FDA) to conduct a Phase 2 study of ADXS-HPV (ADXS11-001) alone or in combination with Incyte Corp's (INCY) investigational oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor, epacadostat (INCB24360), for the treatment of Stage I-IIIb human papillomavirus (:HPV)-associated cervical cancer.
  • "The FDA clearance of the ADXS-HPV plus epacadostat IND for HPV-associated early stage cervical cancer adds to Advaxis's rapidly advancing pipeline in cervical cancer," stated Daniel J. O'Connor, President and Chief Executive Officer of Advaxis. "Additionally, the acceptance of this IND strengthens our pipeline of combination studies involving our Lm-LLO platform and aligns our technology with another potentially best-in-class immunotherapy technology. We look forward to the initiation of this study with Incyte."

7:33 am TTM Tech updates guidance after completing Viasystems acquisition (TTMI) : Co has completed its acquisition of Viasystems Group. With pro forma 2014 combined annual revenue of $2.5 billion, TTM is now one of the world's largest and most diversified PCB manufacturers with a broad product offering and the enhanced ability to support customers' product lifecycles from engineering support to prototype development through final volume production.

  • TTM's performance for its historic operations is tracking with its previously issued guidance. 
  • However, TTM is updating its guidance for the second quarter of 2015 to reflect the one month contribution from Viasystems. 
  • TTM now expects Q2 rev in the range of $420-460 million, compared to its previous expectation of $330-350 million (consensus $340 mln), and non-GAAP net income in the range of $0.11 to $0.17 per diluted share consistent with prior guidance (consensus $0.14). 
  • TTM will provide further information regarding the acquisition during its second quarter earnings conference call in mid-August. 
  • In conjunction with the closing of the transaction, TTM entered into a $950 million Senior Secured Term Loan B credit facility.

7:32 am NanoString Technologies highlights results from three significant new prosigna studies presented at ASCO; confirms the clinical significance of the Prosigna Breast Cancer Assay based on the PAM50 gene signature (NSTG) : Co highlighted the results from three important studies presented at ASCO, which confirm the clinical significance of the Prosigna Breast Cancer Assay based on the PAM50 gene signature.

7:31 am VBL Therapeutics updates interim results from its ongoing Phase 2 study of VB-111 in patients with recurrent glioblastoma: VB-111 in combination with bevacizumab demonstrated significant improvement in overall surviva (VBLT) : Co announced updated interim results from its ongoing Phase 2 study of VB-111 in patients with recurrent glioblastoma (rGBM). Data showed a statistically significant overall survival benefit in patients treated with VB-111 followed by VB-111 in combination with bevacizumab (Avastin) upon disease progression, compared to patients treated with VB-111 followed by bevacizumab alone (p=0.05). These study results will be presented in greater detail at VBL's Analyst and Investor Meeting today, Monday, June 1, 2015, in conjunction with ASCO.

  • VB-111 in combination with bevacizumab demonstrated significant improvement in overall survival, with median overall survival of 16 months, compared to eight months in patients on VB-111 followed by bevacizumab alone (p=0.05).
  • VBL's pivotal Phase 3 clinical trial will be led by Timothy Cloughesy, MD, Professor of Clinical Neurology and Director of the Neuro-Oncology Program, UCLA School of Medicine and is expected to initiate in mid-2015 under a special protocol assessment granted by the FDA.

7:31 am Textura confirms receipt of letter from Investor Northwater Capital recommending that the Board of Directors of Textura explore strategic alternatives; Board will consider recommendations (TXTR) : Co's Board of Directors has received a letter from Board member David Patterson on behalf of Northwater Capital Management Inc., of which he is Chief Executive Officer and Chair, and the investment funds it advises, recommending that the Board of Directors of Textura explore strategic alternatives, including a sale of Textura. Northwater-affiliated entities own approximately 19% of Textura.

  • The Board intends to consider the recommendations contained in Northwater's letter and will determine what is in the best interests of Textura's shareholders

7:31 am Fifth Street Senior Floating Rate announces issuance of $222.6 million of long-term secured notes to refinance its existing $200 million credit facility (FSFR) : The $222.6 mln in notes consist of $126 million of Class A-T Notes at LIBOR plus 1.80%; $29 million of Class A-S Notes at LIBOR plus 1.55%; $20.0 million of Class A-R Revolving Notes at Commercial Paper plus 1.80%; $25.0 million of Class B Notes at LIBOR plus 2.65%; and $22.6 million of Class C Notes at LIBOR plus 3.25%. The vehicle has a four-year reinvestment period with a ten-year maturity and two-year non-call period

7:30 am Cleveland Biolabs announces the release of results from its Phase 1 open-label, dose-escalation trial of entolimod in patients with advanced cancer (CBLI) : Stable disease for more than 6 weeks was observed in 8 patients with various cancer types; among these, 3 patients had maintenance of stable disease for more than 12 weeks. Patients exhibited CD8+ T-cell activation with stable or decreased levels of myeloid-derived suppressive cells, accompanied by increased immunostimulatory cytokines.

  • The tolerability profile in patients with advanced cancer was similar to that observed in two previously conducted studies in 150 healthy volunteers receiving entolimod. Common adverse events were flu-like symptoms and fever, with some patients having transient, spontaneously resolving tachycardia, hypotension, and hyperglycemia. 
  • Overall, treatment with entolimod was well tolerated.

7:30 am Anacor Pharma names Graeme Bell as New Executive Vice President and Chief Financial Officer, effective June 1, 2015 (ANAC) : Co announces that Graeme Bell will join Anacor as its new Executive Vice President and Chief Financial Officer. Bell joins Anacor from Merck (MRK), where he served since 2010 as its Vice President, Country CFO, U.S. Human Health, responsible for the financial oversight and support of MRK's pharmaceutical and vaccine business.

7:30 am Endeavour Silver confirms thick, high grade, silver-gold mineralization at Terronera Property, Jalisco State, Mexico; believes Terronera vein holds excellent potential for additional discoveries (EXK) : Co announces that infill drilling on the Terronera property in Jalisco State, Mexico continues to define high grade, silver-gold mineralization within the Terronera vein system. Recent drilling highlights include 1,371 grams per tonne (gpt) silver and 1.10 gpt gold (1,448 gpt silver equivalent (AgEq)) over 6.6 m true width, or 42.2 ounces per ton (opT) AgEq over 21.6 feet (ft), including 5,420 gpt silver and 5.12 gpt gold (5,778 gpt AgEq) over 0.3 m true width, or 171.6 opT AgEq over 1.0 ft in hole TR10-4.

  • "The Terronera vein holds excellent potential for additional discoveries along strike and it is the first of several prospective veins to be drilled on the Terronera property. Our goal for 2015 is to complete the pre-feasibility study by the fourth quarter. We believe Terronera has the potential to become a high-grade, underground silver-gold mine similar to our Bolaitos mine in Guanajuato."

7:30 am ArQule announces the appointment of Robert Weiskopf as CFO (ARQL) : Weiskopf was previously vice president of finance, corporate controller and treasurer of ArQule

7:29 am On the Wires (:WIRES) :

  • Radius Health (RDUS) announced that it has engaged Myrtle Potter & Company, to support the development of the future global commercial strategy for its lead investigational drug abaloparatide-SC for the potential treatment of post-menopausal osteoporosis.
  • Apricus Biosciences (APRI) announced that it has begun enrolling patients in a Phase 2b clinical trial to evaluate Apricus' novel product candidate, fispemifene, a selective estrogen receptor modulator, for the treatment of men with symptomatic secondary hypogonadism also known as low testosterone.
  • Trina Solar Limited (TSL) announced that it provided Osaka Sangyo University with its newly developed Interdigitated Back Contact cells and modules for OSU's Solar Car
  • Iridium Communications (IRDM) announced it has completed the first satellite payload-to-bus integration on an Iridium NEXT satellite. The successful mating of the communication payload and the Aireon hosted payload to the platform, is a critical milestone achieved in the production process, bringing the overall constellation closer to launch.
  • Hercules Offshore (HERO) announced that it received a notice from Saudi Aramco withdrawing the previously issued notice of termination with respect to the contract for the Hercules 261 and declaring that all terms and conditions of the contract remain in full force and effect for the remainder of the five-year term of the contract. The dayrates on this rig, the Hercules 262 and the Hercules 266, which are also under contract with Saudi Aramco, are expected to be significantly reduced to bring such dayrates in line with current market rates for similarly-classed rigs in the region
  • City Office REIT (CIO) announced that it has entered into an Agreement of Purchase and Sale to acquire DTC Crossroads in Denver, Colorado for a purchase price of $35 million. DTC Crossroads is a 191,402 square foot Class 'A' multi-tenant office property that is 91% occupied
  • Applied Genetic Technologies Corporation (AGTC) announced the appointment of Rabia Ozden, M.D. as Vice President of Clinical Research and Development.
  • Jackson National Life Insurance Company announced the appointment of Barry Stowe as chairman and chief executive officer of the North American Business Unit of Prudential plc (PUK) which includes Jackson and its affiliated and subsidiary companies.

7:09 am Harsco announces an offering of $250 mln in senior notes due 2020 (HSC) : The Company intends to use the net proceeds from the offering of the Notes to fund a cash tender offer for any and all of its outstanding 2.700% Senior Notes due 2015, with any remaining proceeds from the offering to repay borrowings under its revolving credit facility, and any remaining proceeds thereafter for general corporate purposes.

7:09 am Asian Markets Close: Japan's Nikkei +0.03%; Hong Kong's Hang Seng +0.6%; China's Shanghai Composite +4.7% (:SUMRX) : It was a relatively mixed showing on Monday from markets in the Asia-Pacific region. China's Shanghai Composite, however, wasted little time in trying to get back on track. It surged 4.7% to begin the week with participants again playing the policy stimulus trade as the HSBC Manufacturing PMI report showed the third straight sub-50 reading. A number below 50 denotes contraction.

Economic data

  • Japan
    • Q1 Capital Spending +7.3% year-over-year (expected -0.1%; prior +2.8%)
    • May Manufacturing PMI 49.2 (expected 49.2; prior 49.1)
  • China
    • May HSBC Manufacturing PMI 49.2 (expected 49.2; prior 49.1)
    • May Manufacturing PMI 50.2 (expected 50.2; prior 50.1)
    • May Non-Manufacturing PMI 53.2 (prior 53.4)
  • Australia
    • May AIG Manufacturing Index 52.3 (prior 48.0)
    • May MI Inflation Gauge +0.3% (prior +0.3%)
    • Q1 Business Inventories +0.4% month-over-month (expected +0.1%; prior -0.8%)
    • April Building Approvals -4.4% month-over-month (expected -2.0%; prior +2.9%)
    • April Private House Approvals +4.7% (prior +1.8%)
  • South Korea
    • May HSBC Manufacturing PMI 47.8 (expected 49.0; prior 48.8)
    • May Trade Balance KRW 6.30 bln (expected KRW 6.20 bln; prior KRW 8.50 bln)
      • May Exports -10.9% year-over-year (expected -9.0%; prior -8.0%)
      • May Imports -15.3% year-over-year (expected -13.2%; prior -17.8%)
  • India
    • May HSBC Markit Manufacturing PMI 52.6 (expected 51.2; prior 51.3)
Equity Markets
  • Japan's Nikkei eked out a 0.03% gain after trading in negative territory for most of Monday's session. The fractional gain was the twelfth consecutive increase for the Nikkei. The utilities (+1.9%) sector was the best-performing area while the consumer cyclical sector (-0.2%) lagged all others. Individual standouts included Nippon Suisan Kaisha (+4.6%), Teijin Ltd (+3.9%), and Tokyo Electric Power (+3.8%). Yahoo Japan (-3.2%) paced the decliners. Out of the 225 index members, 126 ended higher, 92 finished lower, and 7 were unchanged.
  • Hong Kong's Hang Seng increased 0.6%, following mainland shares higher. The advance was driven by the financial sector (+1.1%). The consumer cyclical sector (-2.1%) was the only sector to lose ground. Belle Intl. (+5.3%), Bank of Communications (+4.5%), and China Resources Power Holdings (+3.5%) were the best-performing issues. Galaxy Entertainment (-4.5%) and Sands China (-3.7%) led the decliners. Out of the 50 index members, 34 ended higher, 12 finished lower, and 4 were unchanged.
  • China's Shanghai Composite surged 4.7%. The rebound effort was fueled by renewed thoughts that more policy stimulus may soon be provided. That thinking was helped along by the HSBC Manufacturing PMI report, which at 49.2 was up a tick from March but still the third straight month of contraction. The diversified (+7.2%), utilities (+6.9%), and technology (+6.4%) sectors led the gains in the Chinese market on Monday where every sector gained at least 4.0%.
  • India's Sensex increased 0.1%, paced by the industrial (+2.8%), energy (+1.3%), and consumer cyclical (+1.2%) sectors. Individual standouts included Larsen & Toubro (+3.1%), Reliance Industries (+2.9%), and Maruti & Suzuki India (+2.6%). Sun Pharmaceutical (-9.2%), Bharti Airtel (-2.1%), and Tata Motors (-2.0%) were the worst-performing issues.
  • Australia's S&P/ASX 200 declined 0.7%, held back by a weak showing from the consumer staples (-1.3%) and metals & mining (-1.3%) sectors. Sirtex Medical (+14.4%) was the biggest gainer while Seven Group Holdings (-6.2%) led the laggards.
  • Regional advancers: Philippines +1.2%, Vietnam +1.0%
  • Regional decliners: Taiwan -0.8%, South Korea -0.6%, Malaysia -0.2%, Indonesia -0.1%
  • Closed for holiday: Singapore (Vesak Day) and Thailand (Wisakha Bucha Day)
FX
  • USD/CNY +0.02% at 6.1995
  • USD/INR -0.1% at 63.693
  • USD/JPY -0.1% at 124.06

7:06 am Flotek Industries announces the appointment of Robert Schmitz as CFO, succeeding H Richard Walton who has been named Chief Financial Officer Emeritus (FTK) : Schmitz served as Flotek's Vice President and Corporate Controller since June, 2013. Schmitz and Mr. Walton will remain based in the Company's Houston headquarters. Flotek does not anticipate any significant additional accounting staff changes as a result of Mr. Schmitz's promotion.  

7:05 am PartnerRe files investor presentations related to proposed merger with AXIS Capital (AXS); urges shareholders to vote for the deal with AXS and not for EXOR deal (PRE) :  

7:05 am Actavis completes acquisition of Auden Mckenzie for approximately 306 million in cash; deal was originally announced in January (ACT) :  

7:05 am Applied Genetic Technologies appoints Mark Shearman, Ph.D. as its Chief Scientific Officer (AGTC) : Shearman was employed most recently by EMD Serono, the U.S. and Canadian subsidiary of Merck KGaA (MKGAY.PK), where he served as Senior Vice-President of Research & Early Development since 2009. Previously, Dr. Shearman was Executive Director of Merck & Co (MRK).

7:05 am Albany Molecular announces that it has signed a collaborative agreement with HarkerBIO LLC to co-market their structure-based drug discovery services to pharma and biotech clients (AMRI) : As part of the three-year agreement, AMRI gains access to HarkerBIO's high-resolution, structure-determination expertise and capabilities. HarkerBIO's customers will be able to access and benefit from AMRI's integrated drug discovery platforms and solutions. Financial terms not disclosed

7:04 am NGL Energy Partners reports FY15 results (NGL) :

  • FY15 EPS ($0.29) vs ($0.42) Capital IQ Consensus; revs +73% $16.8 mln vs $18.22 bln Capital IQ Consensus 
    • Adjusted EBITDA of $443.3 million for the year ended March 31, 2015 (exclusive of $7.4 million of advisory and legal costs related to acquisitions and $15.8 million of compensation costs related to the Gavilon and TransMontaigne acquisitions), compared $270.5 mln last year. 
    • "Given the challenging energy environment, NGL significantly exceeded expectations and guidance. This is a testament to our strategy of having an integrated and diversified portfolio of midstream businesses which serve as a natural hedge against commodity risk."

7:04 am The Medicines Co announces the results of its Phase 1 study for ABP-700, which showed rapidly reversible, linearly dose-proportional pharmacokinetics and pharmacodynamic effects (MDCO) : Study results showed linearly dose proportional pharmacokinetics and pharmacodynamic effects which were rapidly reversible, consistent with pre-clinical animal studies. Adverse events were mild with the exception of one subject with moderate tachycardia. No serious adverse events were reported.

  • Co additionally noted that full results of ANVN-01 as well as preliminary results of ANVN-02, the ongoing Phase I infusion study, will be presented at an upcoming medical conference

7:04 am Celladon: Following review of CUPID2 Data, co hired Wedbush to seek an acquisition or partnership, Paul Cleveland replaces Krisztina Zsebo as CEO, who resigned (CLDN) : Board of Directors has unanimously approved a strategic plan pursuant to which the Company will immediately commence a process to seek an acquisition or partnership. The Company also announced that it has retained Wedbush PacGrow Healthcare as its exclusive financial advisor. The Board also unanimously approved a leadership succession plan, pursuant to which Paul Cleveland has been promoted to Chief Executive Officer of Celladon and appointed to its Board of Directors, effective immediately. Krisztina Zsebo, Ph.D, who had been Celladon's Chief Executive Officer, has resigned from the Company and its Board of Directors.

7:02 am Agenus: Updated Phase 2 Data of Prophage In Newly Diagnosed GBM Presented at ASCO Show Improvement in Median Progression Free Survival and Overall Survival Independently of Prognostic Markers, Compared with Historical Expectations (AGEN) : Co announced that patients with newly diagnosed Glioblastoma Multiforme (GBM.V) treated with Prophage (AGEN's individualized heat shock protein (HSP)-based cancer vaccine) plus Standard of Care (SOC.V) show substantially longer Progression Free Survival (PFS) and median Overall Survival (mOS) compared to historical SOC data, as detailed in an oral presentation at ASCO yesterday by Orin Bloch, M.D., Khatib Professor of Neurological Surgery and Assistant Professor of Neurological Surgery and Neurology at Northwestern University Feinberg School of Medicine.

  •  "The results in patients with lower monocyte PD-L1 expression are especially promising. We believe a well-designed, controlled Phase 3 trial of Prophage plus SOC is warranted to try to bring this potential treatment advance to patients afflicted by GBM." 

7:02 am Taomee Holdings announces the receipt of 'going private' proposal at $0.1794/ordinary share or $3.588/ADS (TAOM) : Co announced that its board of directors has received a non-binding proposal letter from Benson Haibing Wang, a director and the chief executive officer of the Company, Roc Yunpeng Cheng, a director and the president of the Company, and Orient Securities Ruide Investment Management  to acquire all of the outstanding shares of the Company in a "going private" transaction at a price of US$0.1794 in cash per ordinary share of the Company or US$3.588 in cash per ADS of the Company.

  • According to the proposal letter, the Consortium Members intend to form an acquisition vehicle for the purpose of implementing the Transaction, and have agreed to work with each other exclusively in pursuing the Transaction. 
  • The Consortium Members intend to finance the Transaction with a combination of equity capital funded by the Consortium Members and third-party debt.

7:02 am Ignyta announces Phase 1 Clinical Trial Data for Entrectinib; 91% response rate in patients meeting expected Phase 2 eligibility criteria (RXDX) : Co announced that interim results from the company's two Phase 1 clinical trials of entrectinib were presented in poster presentations, including a poster discussion, at the 2015 Annual Meeting of the American Society of Clinical Oncology (TATD). Co highlights a 91% response rate in patients meeting expected Phase 2 eligibility criteria and that it was well tolerated, with no drug-related serious adverse events.

7:01 am POZEN announces that John R. Plachetka, founder, Chairman, CEO and President is retiring, effective immediately (POZN) : Dr. Plachetka has also resigned from the Board of Directors of POZEN and has withdrawn as a nominee for election as a director at the 2015 Annual Meeting of Stockholders. Arthur Kirsch, who has served as an independent director since 2004, has been appointed to serve as Chairman of POZEN's Board of Directors. The Board of Directors has appointed Adrian Adams to replace Dr. Plachetka as POZEN's Chief Executive Officer and has also appointed Mr. Adams to serve on the Board of Directors, effective immediately. 

  • POZEN also announced that the Board of Directors has appointed Andrew Koven as President and Chief Business Officer, reporting to Mr. Adams. Mr. Koven most recently served as Chief Administrative Officer and General Counsel of Auxilium Pharmaceuticals Inc.

7:01 am Immunomedics reports complete responses in patients with metastatic triple-negative breast cancer after Sacituzumab Govitecan treatment (IMMU) : Among 49 patients with metastatic triple-negative breast cancer (:TNBC) evaluated for response to treatments with sacituzumab govitecan in a mid-stage clinical study, 31%, or 15 patients, showed a reduction in tumor size of 30% or more. They include 2 patients with complete response. Adding the 22 patients with responses between less than 30% tumor shrinkage and less than 20% tumor increase, the disease control rate was 76%.

  • Sacituzumab govitecan also produced significant duration of response in these responding patients. Measured as the time it takes from the beginning of sacituzumab govitecan treatments to when the cancer progresses, the median progression-free survival (PFS) for the 48 patients who received the optimal doses of 8 or 10 mg/kg was 6.0 months.
  • Importantly, 63% of patients (22 of 35) had a time-to-progression longer than their last therapy, notwithstanding disease progression has not yet happened in 56% of patients at the time of analysis.
  • "We plan to advance the agent to a Phase 3 registration trial, the design of which is being discussed with the regulatory authorities and key opinion leaders."

7:01 am BioDelivery Sciences secured additional $20.7 mln in gross debt funding from MidCap Financial (BDSI) : BDSI and MidCap originally entered into a $20 million secured loan facility in 2013 which has subsequently been paid down to approximately $9.3 million.

7:01 am Biocept announces receipt of a US Patent for its blood collection and transport preservative Diazolidinyl Urea (BIOC) : The granted patent covers Biocept's blood collection preservative contained in the tube for collecting patient blood used for circulating tumor cell and circulating tumor DNA genomic analysis at Biocept.

7:00 am Antares Pharma has received a written update from the FDA related to its clinical development program for QuickShot Testosterone (ATRS) : Co announced that it has received a written update from the U.S. FDA related to its clinical development program for QuickShot Testosterone (QS T) that the Company believes is consistent with its previously disclosed interpretation of the advice letter received from FDA in January 2015.

  • The Company believes that with the update just received from FDA, there is an agreed upon path forward for the completion of an additional study to support the filing of a New Drug Application for QS T. 
  • Based on the number of subjects in previous studies and in the current ongoing phase 3 study, the Company will need approximately 70 additional subjects exposed to QS T for six months, resulting in approximately 350 subjects exposed to QS T, with 200 subjects exposed for six months and 100 subjects exposed for a year. 
  • The Company is now finalizing the protocol for the study and expects to initiate the trial in the third quarter of 2015.

6:59 am Prana Biotech announces that the EC has approved orphan designation for PBT2 for the treatment of Huntington's disease (PRAN) : The approval was based on the recommendation of a positive opinion from the European Medicines Agency's (EMA.TO) Committee for Orphan Medicinal Products

6:57 am Macau Gaming Inspection and Coordination Bureau reports May gross gaming rev -37% YoY (WYNN) : Macau Gaming Inspection and Coordination Bureau reports May gross gaming rev (:GGR) -37.1% YoY at 20.3 bln patacas ($2.55 bln), slightly better than estimates, vs. +9.3% in May 2014 and -38.8% last month. Macau stocks were lower in China.

  • Macau GGR is down 37.1% YTD. 
  • Macau gross gaming rev continues to fall following increased regulation: officials cracked down on the illicit funds flowing through the region via junket operators running the VIP gaming market; a smoking ban in the casinos and macro headwinds are also playing a part.
    • GGR fell 2.6% in 2014 after rising 12.6% in the first half of the year as declines accelerated into year end; GGR grew 18.6% in 2013 and 13.5% in 2012. 
  • Comps will be tough until ~mid-year. 
  • Casino stocks (which fell in China) with exposure to Macau: MPEL, IKGH (junket operator), WYNN, LVS, MGM, SJMHF, GXYEY... BJK.

6:56 am On the Wires (:WIRES) :

  • Pixelworks (PXLW) announced that the new ASUS Hero ZenPad is the first tablet to incorporate Pixelworks' True Clarity display enhancements.
  • Collegium Pharmaceutical (COLL) announced the addition of Barry Duke as Executive Vice President and Chief Commercial Officer. In addition to Duke, Mary Ogle joined as Vice President of Marketing and Timothy Hermes as Vice President of Government Affairs and Alliance Development.
  • Descartes Systems Group (DSGX) announced that Avianca Cargo, a business unit of Avianca Holdings S.A. (AVH), has selected Descartes Cargo 2000, a cloud-based service that provides reporting and analytics to help meet the International Air Transport Association (:IATA) Cargo 2000 standards

6:46 am VWR Corp announces a public offering of 16 mln share of common stock, by a selling stockholder affiliated with Varietal Distribution Holdings (VWR) : BofA Merrill Lynch, Goldman, Sachs & Co. and J.P. Morgan Securities LLC are serving as leadbook-running managers in the offering.

6:41 am Molina Healthcare announces 5 mln share common stock offering, updates FY15 EPS; reaffirms rev (MOH) : Co is updating its outlook for fiscal year 2015 provided on February 12, 2015 to include the impact of improvements in its medical margin, the recently announced expansion in the State of Michigan, a proposed offering of common stock, and increased accounting dilution from its convertible notes due to the Company's stock trading price.

  • Co has commenced an underwritten public offering of 5,000,000 shares of its common stock. In connection with the offering, the Company intends to grant the underwriters a 30-day option to purchase up to 750,000 additional shares of common stock.
    • The Company intends to use the net proceeds of the offering for general corporate purposes, which may include the repayment of indebtedness, funding for acquisitions such as our recently announced expansion in the State of Michigan, capital expenditures, additions to working capital and to meet statutory capital requirements in new or existing states. 
    • UBS Securities LLC, BofA Merrill Lynch and Wells Fargo Securities, LLC are acting as lead book-running managers for the offering. SunTrust Robinson Humphrey, Inc. is acting as a joint book-running manager of the offering.
  • Molina Healthcare sees FY15 EPS $2.90 vs $2.62 Capital IQ Consensus Estimate; reaffirms rev revs $14.3 bln vs $14.27 bln Capital IQ Consensus Estimate

6:33 am Sterling Construction announces a new $40 mln credit facility, secured by its equipment (STRL) : Total debt financing of up to $40 million, is comprised of a $20 million term loan and up to a $20 million revolving credit line. Availability will be determined quarterly based on a 65% advance rate of the appraised value of the collateral pledged. The Initial interest rate is 12% and there are no reported financial covenants

6:32 am Airmedia announces that it has obtained the exclusive right to install and operate Wi-Fi systems on ordinary trains operated by Beijing Railway Bureau (AMCN) : Beijing Railway Bureau has 89 groups of ordinary trains in operation. Co also holds the concession rights to exclusively install and operate Wi-Fi systems on the high-speed trains operated by Beijing Railway Bureau.

6:31 am Asterias Biotherapeutics announces positive, long-term data from a Phase 2 clinical trial of AST-VAC1 in intermediate and high risk acute myelogenous leukemia (AST) : The long-term follow-up showed that more than 50% of patients who received AST-VAC1 had prolonged relapse-free survival, even patients with high-risk AML including those over 60 years old and patients in second remission.

  • Eleven of 19 patients (58%) in the trial remain in CR with a median duration of follow-up of 52 months from first vaccination. Four of the seven patients who were at least 60 years old at the time of immunotherapy with AST-VAC1 remain relapse free 52 to 59 months from first vaccination. The three patients who received AST-VAC1 while in CR2 were in remission as of their last follow-up of 24, 50 and 59 months. Historical results suggest that relapse-free survival in AML patients greater than 60 years old is poor with 10 percent to 20 percent surviving 60 months. 
  • AST-VAC1 was found to be safe and well-tolerated in this study over multiple vaccinations, with up to 32 serial vaccinations administered. Idiopathic thrombocytopenic purpura (grade 3-4) was reported in one patient. Other toxicities (grade 1-2) included rash or headache.

6:30 am Catalent announces a secondary offering of 20 mln shares of common stock by selling stockholders (CTLT) :  

6:22 am British Amrcn Tobacco acquires TDR for EUR550 mln (BTI) : British American Tobacco has signed an agreement to acquire TDR d.o.o. and other tobacco and retail assets from Adris Grupa for a total enterprise value of 550 million.

  • The transaction represents a multiple of ~12.5 times (based on TDR's financial year ending 31 December 2014 EBITDA of ~44 million).
  • By combining its existing business in the region together with TDR, BAT expects to benefit from well established brands, enhanced regional leaf processing capabilities, a local high quality factory and print facility and strong relationships with distributors and retailers in these markets.

6:17 am On the Wires (:WIRES) :

  • BMO Bank of Montrea (BMO) and FreshBooks announced a partnership that will enable BMO small business customers to access FreshBooks' cloud-based accounting software to conduct their day-to-day operations including sending invoices, tracking timesheets, managing expenses and receiving and sending online payments
  • Cesca Therapeutics (KOOL) announced that the Company has appointed Marcum LLP as its independent registered public accounting firm.
  • China Information Technology (CNIT) announced that the Company attended the 2015 Guiyang International Big Data Expo that took place in Guiyang City from May 26, 2015 through May 29, 2015. At the Expo, the Company entered into strategic partnership with the Guiyang municipal government to collaborate on the "CNIT Internet + Smart Guiyang" project."
  • Hilton Worldwide (HLT) announced the signing of a franchise license agreement to open DoubleTree by Hilton Hilo-Naniloa, which will join DoubleTree by Hilton's 100,000-room portfolio and nearly 40,000-room global pipeline. The property, formerly the Hilo Naniloa Hotel and Golf Club, will undergo an $18.5 million large-scale transformation. The 12-story, 3-tower, 388-room property plans to fully convert in December 2015.
  • LLOG Exploration and its partners Ridgewood Energy and Stone Energy Corporation (SGY) announced they have drilled a successful exploration test at the Viosca Knoll 959 "Crown & Anchor" prospect.
  • The Hamburg Port Authority (:HPA) and NXP Semiconductors (NXPI) jointly announced the operation of the first intelligent traffic light for the port of Hamburg.

6:03 am U.S. Concrete acquires the assets of DuBrook Concrete in Chantilly, VA (USCR) : Acquired assets include three ready-mixed concrete batch plants and fleet of 42 mixer trucks

6:02 am OncoSec Medical and UC Davis School of Veterinary Medicine collaborate to test ImmunoPulse IL-12 as an immunotherapy in dogs with soft tissue sarcoma (ONCS) : The study will be an open label, neoadjuvant two-arm pilot trial in approximately 12 canines with soft tissue sarcoma. Eligible canine patients will be randomized to receive one of the two experimental ImmunoPulse IL-12 treatment schedules, followed by definitive surgical resection of the tumor.

6:02 am Eco-Stim announces agreement with ACM Emerging Markets shareholder (ESES) : Co announced that it has entered into an amendment with ACM Emerging Markets Master Fund I, relating to the Company's convertible note agreement. ACM has requested, and the Company has agreed, to give ACM the ability to have the $2,485,163 interest payment, which was due in May, paid in the form of shares of the Company's common stock upon the consummation of a future equity offering, should one occur. In a future equity offering of $24,852,000 million or more, ACM will convert the entire Deferred Interest into shares of common stock at the same price as other investors.

6:01 am New Home announces the resignation of CIO Joseph Davis, effective June 26, 2015 (NWHM) : Davis will continue to serve as a consultant to the company under an agreement with an initial one-year term. As part of the change in management, Wayne Stelmar, the company's Chief Financial Officer and also a company founder, will assume the role of CIO, also effective June 26, 2015. John Stephens, most recently the Senior Vice President and Chief Financial Officer of M. D. C. Holdings, Inc. since 2012, will assume the role of Chief Financial Officer concurrent with Mr. Stelmar assuming the position of CIO.

6:00 am Boot Barn Holdings announces definitive agreement to acquire Sheplers, Inc. for $147 mln in cash (BOOT) : For the twelve months ended March 28, 2015, Sheplers had net sales of approximately $157 million, which included $66 million of e-commerce sales, and Adjusted EBITDA of $14.9 million.

  • The acquisition is expected to generate $6 million to $8 million of annual synergies and be immediately accretive to earnings, excluding estimated one-time transaction and integration expenses of $14 million, and ~10% accretive post integration, which is expected to be completed in calendar year 2016

5:48 am S&P futures vs fair value: +0.70. Nasdaq futures vs fair value: -1.40. :

5:48 am European Markets : FTSE...6974.68...-9.80...-0.10%.  DAX...11372.61...-41.20...-0.40%.

5:48 am Asian Markets : Nikkei...20569.87...+6.70...+0.00%.  Hang Seng...27597.16...+173.00...+0.60%.

5:22 am Abengoa selected by Mexico's CFE to construct 4 new substations in the state of Sinaloa (ABGB) : Co announced has been selected by Mexico's Federal Electricity Commission to construct four new substations in the state of Sinaloa, north-west Mexico. Abengoa will be responsible for the engineering, design, construction and commissioning of the Louisiana Banco 2, San Rafael, Los Mochis I and III substations. The project is expected to be completed within 16 months.

  • The four substations included in the project will require a total investment of $8.7 million

4:41 am On The Wires (:WIRES) :

  • Veeva Systems (VEEV) announced the availability of Veeva OpenData in France - the second European market in just six months - delivering a new approach to data that is open, easy, and global. 
  • SanDisk (SNDK) launched two new, USB 3.0 flash drives -- the 128GB SanDisk Ultra Fit USB 3.0 Flash Drive, the world's smallest USB 3.0; and the 256GB SanDisk Ultra USB 3.0 Flash Drive, SanDisk's highest capacity USB flash drive to-date. 
  • CGG (CGG) announced that its GeoSoftware Business Line is launching major releases across its full product portfolio. Focused on technology innovation, workflow integration and ease of use across all application suites, Jason 9.0, Hampson-Russell HRS 10.0 and Insight Earth 3.0 enable oil and gas companies to better understand and characterize the Earth's subsurface.
  • SanDisk (SNDK) entered the portable SSD market with a family of high-performance drives, including the SanDisk Extreme 900 Portable SSDs. 
  • Microsoft (MSFT) announced that Windows 10 will be available July 29 in 190 countries. 
  • AU Optronics (AUO) announced that it will participate in SID Display Week 2015 to be held from June 2 to 4 in San Jose, USA where it will debut its 6-inch UHD 4K ultra high resolution smartphone display. 
  • TESARO (TSRO) announced the successful completion of the rolapitant bioequivalence study. The results of this study indicate that the exposure for a 185 milligram dose of intravenous rolapitant is similar to the exposure of a 200 milligram dose of oral rolapitant. 

4:28 am Gazit-Globe President to step down; Rachel Lavine will be appointed President (GZT) : Co announced that Roni Soffer, its President, is stepping down towards the end of the year.

  • Rachel Lavine will be appointed President of Gazit-Globe. Rachel Lavine served over the last 6 years as CEO of the Company's subsidiary, Atrium, and currently serves as Chairman of Gazit-Globe Israel, Deputy Chairman of Atrium, and as a director on the boards of Gazit-Globe and Citycon.

4:24 am Pluristem Therapeutics granted key cell patents in Asia, Russia, Mexico, and Israel (PSTI) : Co announced it has been granted patents covering cell manufacturing, pharmaceutical compositions and disease treatment in China, South Korea, Mexico, Russia, and Israel. The patent titled "Adherent Cells from Placenta Tissue and Use Thereof in Therapy" has also been issued to Pluristem by Rospatent in Russia under patent #RU2539786. This patent addresses adherent placental cells that have been cultured under 3D conditions.

4:11 am Roche Hldg: Genentech's Perjeta regimen helped people with HER2-positive early breast cancer live longer without their disease returning (RHHBY) : Co announced new results from the Phase II NeoSphere study. The results suggested that Perjeta in combination with Herceptin and docetaxel chemotherapy given prior to surgery reduced the risk of disease getting worse and increased the time people lived without their cancer returning compared to Herceptin and chemotherapy in people with HER2-positive early breast cancer. The safety profile of the Perjeta regimen was consistent with that seen in previous studies, and no new safety signals were identified.

4:00 am Foundation Medicine promising clinical outcomes underscoring the importance of integrating comprehensive genomic profiling with FoundationOne (FMI) : Co presented new data including promising clinical outcomes underscoring the importance of integrating comprehensive genomic profiling with FoundationOne into clinical oncology care for the treatment of biliary tract cancers. Foundation Medicine conducted comprehensive genomic profiling of tumor samples from 554 patients with a broad range of advanced biliary tract cancers and determined that two-thirds of patients harbored clinically relevant genomic alterations, which could potentially influence and personalize treatment and guide the selection of approved targeted therapies or access to novel therapies available in clinical trials.

Results of comprehensive genomic profiling showed the following

  • IHCCA, EHCCA and GBCA share frequent genomic alterations in cell cycle regulation (CDKN2B) and chromatin remodeling (ARID1A). 
  • IHCCA is further characterized by FGFR fusions, IDH1/2 substitutions, BRAF substitutions and MET amplification with a low KRAS mutation frequency. 
  • EHCCA and GBCA have frequent ERBB2 amplifications (GBCA > EHCCA) and PIK3CA/MTOR pathway alterations. 
  • KRAS mutation frequency is high in EHCCA and low in GBCA. 
  • In the case of some mutations, including KRAS, BAP1 and FGFR, there is a correlation with cancer prognosis. This has important implications regarding the choice of therapy.

3:44 am Infinity Pharmaceutical reports Phase 1 data showing clinical activity of Duvelisib; clinical activity observed in high-risk CLL patients (INFI) : Co announced new clinical data for duvelisib, an oral, dual inhibitor of phosphoinositide-3-kinase-delta and PI3K-gamma in patients with treatment-nave chronic lymphocytic leukemia, a potentially fatal hematologic malignancy. Data from the Phase 1 study showed that duvelisib was highly active in this patient population cohort, with an overall response rate of 88 percent as defined by the International Workshop on Chronic Lymphocytic Leukemia criteria, including 15 partial responses among 17 efficacy evaluable patients.

  • Data showed that duvelisib is clinically active in patients with treatment-nave CLL, with an 88 percent overall response rate (15 partial responses out of 17 evaluable patients) as defined by the iwCLL criteria. 
  • Additionally, two patients exhibited stable disease. The median time to response was 3.7 months. The median progression free survival and median overall survival have not yet been reached, with a 92 percent PFS rate and 94 percent OS rate at 18 months.

3:33 am Sunesis Pharma presents post hoc analysis shows promising outcomes for Vosaroxin/Cytarabine-treated patients (SNSS) : Co announced results from a post hoc subgroup analysis of patients age 60 years and older who underwent allogeneic hematopoietic cell transplant in the VALOR trial, a Phase 3 study of vosaroxin and cytarabine in patients with relapsed or refractory acute myeloid leukemia.

  • Of the 711 patients enrolled in VALOR, 451 patients were age 60 years and older. Of these, 226 patients were randomized to the vosaroxin/cytarabine arm and 225 patients to the placebo/cytarabine arm. 
  • For the subgroup analysis, complete remission rates prior to HCT, post-treatment HCT rates, HCT outcomes, and overall survival by treatment arm were assessed. 
  • Of the 451 patients, HCTs were performed in 91 patients, including 47 patients in the vosaroxin/cytarabine arm and 44 patients in the placebo/cytarabine arm. Of these patients, 27 (57%) achieved a CR prior to transplant in the vosaroxin/cyrarabine arm versus 16 (36%) in the placebo/cytarabine only arm. 
  • An additional 7 and 6 patients on the respective treatment arms received subsequent therapy, and went on to achieve a CR, resulting in a total of 34 patients (72%) in the vosaroxin/cytarabine arm and 22 patients (50%) in the placebo/cytarabine arm achieving CR prior to transplant.

3:26 am AstraZeneca presents positive data on AZD9291 in first-line EGFR mutated lung cancer (AZN) : Co announced preliminary efficacy and safety data for AZD9291 in the first-line treatment of epidermal growth factor receptor mutation positive advanced non-small cell lung cancer. Data showed that 81% (95% confidence interval 68% to 89%) of patients on a once daily dose of AZD9291 were progression free at 9 months; overall response rate was 73%. The longest duration of response was ongoing at 13.8 months at the time of data cutoff.

3:21 am Exelixis announces positive results from Phase 2 investigator-sponsored trial of cabozantinib in RET-rearranged non-small cell lung cancers (EXEL) : Co announced positive results from a two-stage phase 2 investigator-sponsored trial evaluating cabozantinib in patients with advanced RET-rearranged lung cancers. Data were reported for the first stage, which enrolled 16 patients. The objective response rate was 38% (6/16), with a median duration of response of 8 months. Although the trial is still accruing, it has already met its primary endpoint, exceeding the predefined targeted number of five objective responses.
Study Results

  • Data were presented for the 16 patients enrolled in the first stage of the trial. The median age for patients in the first stage of the trial was 59 (range 38-80 years), and 62 percent (10/16) of these were female. All patients in the first stage had adenocarcinoma, the median number of prior lines of chemotherapy was 1, and 31% of patients had received = 2 lines of prior chemotherapy.
  • Sixteen patients from the first stage of the trial were evaluable for tumor response. ORR, the primary endpoint of the trial, was 38%, with six confirmed PRs recorded. The median duration of response was 8 months (range 5.5-26 months) including one patient with a confirmed partial response who remained on treatment more than 25 months. One patient with a best response of stable disease remained on cabozantinib treatment for more than 21 months. ORR at 12 weeks, a secondary endpoint, was 36%, with five confirmed PRs recorded among the 14 patients evaluable at 12 weeks.

3:16 am Merrimack Pharma: PharmaEngine announces filing NDA of MM-398 to Taiwan FDA (MACK) : PharmaEngine announced that a NDA has been submitted to the Taiwan Food and Drug Administration for MM-398 (irinotecan liposome injection, also known as nal-IRI) in patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy.

  • The filing of MM-398 to the TFDA follows the recent submissions of NDA and marketing authorization application by its licensing partner, Merrimack Pharmaceuticals (MACK) and its sublicensing partner, Baxter International's BioScience business (BAX) to the US FDA and to the European Medicines Agency, respectively. 
  • The filing of MM-398 to the TFDA was supported by the positive data from a phase 3 study conducted in patients with metastatic pancreatic cancer who previously received gemcitabine-based therapy.

3:07 am Bristol-Myers' Opdivo demonstrates superior survival compared to standard of care (BMY) : Co announced results from CheckMate -017, a Phase III, open-label, randomized study evaluating Opdivo versus docetaxel in previously treated patients with advanced squamous non-small cell lung cancer.

  • At one year, Opdivo demonstrated an overall survival rate of 42% versus 24% for docetaxel, with a median overall survival of 9.2 months versus 6 months, respectively. In the trial, Opdivo reduced the risk of death by 41%, based upon a hazard ratio of 0.59. 
  • The safety profile of Opdivo in CheckMate -017 was consistent with prior studies and favorable versus docetaxel. 
  • Findings from CheckMate -017 were published today in The New England Journal of Medicine

3:03 am Astellas Pharma announces preliminary Phase 1/2 safety, tolerability and efficacy data for ASP2215 (ALPMY) : Co announced that preliminary data from a Phase 1/2 trial on the safety, tolerability and efficacy of ASP2215, a selective inhibitor of FLT3/AXL, in patients with relapsed or refractory acute myeloid leukemia.

  • ASP2215 demonstrated inhibitory activity against FLT3 internal tandem duplication as well as tyrosine kinase domain, two common types of FLT3 mutations that are seen in up to one third of patients with AML. 
  • Preliminary data from the Phase 1/2 trial demonstrated a 57.5 percent overall response rate and a 47.2 percent composite Complete Response (CR) rate (CR + CR with incomplete platelet recovery + CR with incomplete hematologic recovery) in 106 patients with FLT3 mutations who received 80 mg and higher doses.
  • Furthermore, median duration of response was 18 weeks across all doses and median overall survival was approximately 27 weeks at 80 mg and above in FLT3 mutation positive patients.

2:56 am Bristol-Myers reports Phase III CheckMate -067 trial demonstrates superior progression-free survival of Opdivo+Yervoy regimen (BMY) : Co announced positive results of a Phase III trial evaluating the Opdivo+Yervoy regimen or Opdivo monotherapy vs. Yervoy monotherapy in patients with previously untreated advanced melanoma.

  • Both the Opdivo+Yervoy regimen and Opdivo monotherapy showed superior progression-free survival and objective response rate vs. Yervoy monotherapy 
  • Opdivo+Yervoy regimen showed improved outcomes vs. Opdivo monotherapy in PD-L1 non- and low-expressers (
  • Safety profile of the Opdivo+Yervoy regimen from this trial was consistent with previously-reported studies

2:54 am TG Therapeutics presents TG-1101 Plus TGR-1202 data; data from both studies continues to demonstrate a favorable safety profile with a high level of activity (TGTX) : Co announced clinical results from two ongoing studies of its oral, once-daily, PI3K delta inhibitor, TGR-1202, as a single agent and in combination with TG-1101, the Company's novel glycoengineered anti-CD20 monoclonal antibody.

  • Data from both studies (over 135 patients combined between single agent and combination studies) continues to demonstrate a favorable safety profile with a high level of activity and a significant dose-response relationship observed 
  • 85% (11 of 13) CLL/SLL patients treated at the higher doses of 1202 as a single agent and in combination with TG-1101 achieved a nodal response, with most CLL patients achieving a Partial Response per iwCLL (Hallek 2008) criteria with patients on study pending further assessment
  • 50% (3 of 6) Overall Response Rate (ORR.V) in Follicular Lymphoma (FL) patients treated with the higher doses of single agent TGR-1202
  • 41% (3 of 7) ORR in patients with Diffuse Large B-Cell Lymphoma (:DLBCL) treated at the higher doses of the combination of TG-1101 and TGR-1202, and a clinical benefit rate (patients achieving stable disease or better) of 86% (6 of 7)
  • TGR-1202 alone and in combination with TG-1101 continues to be well-tolerated with limited Grade 3/4 events and =5% of the patients across both studies discontinuing for adverse events, none of which were hepatic toxicity or colitis, with over 50 patients between both studies on therapy 6+ months

2:52 am Karyopharm Therapeutics presents clinical data for selinexor; demonstrates durable anti-tumor activity or disease control across several gynecologic cancers (KPTI) : Co announced the presentation of positive clinical data for its lead product candidate, Selinexor (KPT-330), a first-in-class, oral Selective Inhibitor of Nuclear Export / SINE compound.

  • In an ongoing Phase 2 clinical trial evaluating the activity of single-agent selinexor in patients with heavily pre-treated, progressive gynecological cancers, oral selinexor showed promising anti-tumor activity or disease control across ovarian, endometrial and cervical cancers with disease control rates of up to 62% and several patients remaining on study for up to 12 months. 
  • In a Phase 1 clinical trial evaluating the activity of selinexor in Asian patients with advanced malignancies, single-agent selinexor demonstrated anti-tumor activity across a variety of malignancies in this patient population.

2:51 am Halozyme Therapeutics' Phase 2 clinical study of investigational drug PEGPH20 shows doubling of progression-free survival and improvement trend in overall survival in high HA metastatic pancreatic cancer patients (HALO) : Co announced interim findings from the ongoing phase 2 clinical study of its investigational new drug PEGPH20 for the potential treatment of patients with metastatic pancreatic cancer. The trial included 135 treated patients in stage 1, of whom a total of 44 patients -- 23 receiving PEGPH20 in combination with ABRAXANE and gemcitabine and 21 receiving ABRAXANE and gemcitabine alone had available biopsies that were determined in a retrospective analysis to have high levels of hyaluronan. PEGPH20 targets HA to help improve cancer therapy access to tumor cells. Results reported include:

  • A more than doubling of median progression-free survival of 9.2 months versus 4.3 months in high HA patients treated with PAG vs. AG 
  • A more than doubling of overall response rate of 52 percent versus 24 percent (p-value of 0.038) and a duration of response of 8.1 months compared to 3.7 months in high HA patients treated with PAG versus AG 
  • In the 30 high HA patients (15 PAG treatment arm versus 15 AG treatment arm) who were evaluated for response prior to the April 2014 clinical hold and subsequent PEGPH20 treatment discontinuation, the overall response rate was 73 percent versus 27 percent, respectively, consistent with findings presented in January
  • A trend toward improvement in median overall survival of 12 months compared to 9 months in high HA patients treated with PAG versus AG (hazard ratio of 0.62) despite discontinuation of PEGPH20 in more than half of the PAG-treated patients at the time of the clinical hold in April 2014.

2:48 am Novartis drugs Tafinlar and Mekinist shows significant survival benefit in patients with metastatic melanoma (NVS) : Co announced data from the Phase III COMBI-d study showing a significant survival benefit for patients with BRAF V600E/K mutation-positive metastatic melanoma when treated with the combination of Tafinlar and Mekinist compared to Tafinlar monotherapy alone. This is the first combination of BRAF/MEK inhibitors to demonstrate a statistically significant overall survival benefit for this patient population in two Phase III studies.

  • The final analysis included the 423 patients enrolled in COMBI-d and showed that the combination of Tafinlar and Mekinist achieved a statistically significant overall survival benefit compared to Tafinlar monotherapy (median of 25.1 months vs 18.7 months). 
  • The analysis for the combination also showed median progression-free survival of 11.0 months, overall response rate of 69%, and median duration of response of 12.9 months. 
  • The safety results were consistent with the profile observed to date for the combination and consistent with the profile observed for Tafinlar monotherapy; no new safety concerns were observed. 
  • The most common adverse events (>=20%) in the combination arm were pyrexia, fatigue, nausea, headache, chills, diarrhea, rash, joint pain, hypertension, vomiting, cough and peripheral edema

2:41 am AbbVie analysis of Phase III RESONATE data shows adherence to the recommended 420mg dose of IMBRUVICA; results in improved efficacy benefits in patients with chronic lymphocytic leukemia (ABBV) : Pharmacyclics LLC today highlighted results from a sub-analysis of the Phase III RESONATE (PCYC-1112) trial, which found that previously-treated patients with chronic lymphocytic leukemia who adhered to the recommended 420 mg dose of IMBRUVICA experienced improved progression-free survival (PFS; the primary endpoint) as assessed by an Independent Review Committee, compared to patients who took lower doses or missed doses, regardless of high-risk genetic factors.

  • Notably, the recommended 420 mg dose was associated with longer PFS rates (median not reached) compared to those patients who took lower doses (11 months), regardless of high-risk factors including del 17p, del 11q or p53 mutations. 
  • Patients who consistently missed their IMBRUVICA dose for eight or more consecutive days experienced more events compared to patients who did not experience such dose holds (31% vs. 13%, respectively). 
  • The mean duration of missed doses in patients who missed more than one week of therapy was 26 days.

2:38 am Celldex Therapeutics randomized Phase 2 ReACT study of RINTEGA demonstrates statistically significant overall survival and emergence of long-term survival benefit; primary endpoint of PFS6 met (CLDX) : Co presented positive results from the Company's randomized, double-blind Phase 2 study of RINTEGA in patients with EGFRvIII-positive, recurrent glioblastoma at ASCO. The primary endpoint of the study, progression-free survival at six months was met, and a clear advantage was demonstrated across multiple, clinically important endpoints including overall survival, long-term progression-free survival, objective response rate and need for steroids.

  • Clinical benefit observed across multiple endpoints, including PFS, OS, ORR and steroid requirement
  • All subgroup analyses favor RINTEGA treatment

2:37 am Mirati Therapeutics initial data from ongoing expansion study of MGCD265; shows preliminary evidence of clinical efficacy in heavily pretreated NSCLC (MRTX) : Co presented data that demonstrated preliminary evidence of clinical activity from its investigational targeted tyrosine kinase inhibitor candidate, MGCD265, as part of the developmental therapeutics category at ASCO. The Company also provided updates on its other targeted tyrosine kinase inhibitor, MGCD516, and spectrum-selective HDAC inhibitor, mocetinostat. Both MGCD516 and mocetinostat were presented as clinical trials in progress at the conference.

  • The first three patients selected for MET Gene alterations in MGCD265 dose expansion cohort show clear evidence of tumor regression
  • MGCD265 is well tolerated in dose escalation and dose expansion phases

2:35 am Curis reports CUDC-907 data from the ongoing Phase 1 trial (CRIS) : Co announced results from the completed dose escalation and ongoing expansion stages of a Phase 1 trial of CUDC-907, an oral dual inhibitor of histone deacetylase and phosphoinositide 3-kinase enzymes.

  • CUDC-907 (HDAC and PI3K Inhibitor) demonstrates objective responses, including complete responses, in patients with relapsed/ refractory DLBCL
  • Expansion phase ongoing in patients with relapsed/ refractory DLBCL with recommended dose and schedule as monotherapy and in combination with standard dose of rituximab

2:29 am Threshold Pharma presents encouraging preliminary Phase 2 data in multiple myeloma (THLD) : Co announced new preliminary data from the Phase 2 component of an ongoing Phase 1/2 trial of evofosfamide (an investigational compound formerly known as TH-302) in combination with the proteasome inhibitor Velcade and low-dose dexamethasone in patients with relapsed/refractory multiple myeloma. A clinical benefit rate of 29% (one complete response, two partial responses, and one minimal response) was observed in patients treated at the recommended Phase 2 dose of evofosfamide in EBorD.

  • Preliminary safety and tolerability results from the 18 patients included in the ASCO presentation support further investigation of evofosfamide in patients with relapsed/refractory multiple myeloma.
  • Preliminary results from the 18 patients included in the ASCO presentation suggested anti-myeloma activity of EBorD therapy.

2:23 am Foundation Medicine presents new data demonstrate improved patient outcomes with matched cancer therapy informed by comprehensive genomic profiling with FoundationOne (FMI) : Foundation Medicine (FMI) and collaborators from the University of Texas MD Anderson Cancer Center and Sarah Cannon Research Institute at HealthOne today announced compelling new data demonstrating that matching patients to targeted therapies based on the unique molecular profile of the patient's advanced cancer leads to improved outcomes across a variety of key measures, including overall survival.

  • Tumor samples from patients with clinically relevant molecular alterations as identified by FoundationOne were preferentially treated on pathway-matched therapies. 
  • A direct match was defined when the drug targeted an alteration or its immediate downstream effector; an indirect match when the drug targeted a protein with more than one effector removed from the alteration. 
  • Based on matching and the number of alterations in patients' tumors, an exploratory scoring system was evaluated.

2:19 am Clovis Oncology's Rociletinib (CO-1686) Phase 2 study results demonstrate consistent and promising clinical activity and disease control (CLVS) : Co reported updated findings from its Phase 2 clinical study of rociletinib (CO-1686), the Company's novel, oral, targeted covalent mutant-selective inhibitor of the epidermal growth factor receptor for the treatment of non-small cell lung cancer in patients with initial activating EGFR mutations, as well as the dominant resistance mutation T790M.

  • 60% overall response rate and 90% disease control rate in heavily pretreated centrally confirmed tissue T790M-positive patients 
  • Median progression free survival of 10.3 months observed in patients without a history of CNS metastases; median PFS of 8 months observed in overall population of 270 heavily pretreated centrally confirmed tissue T790M-positive patients, including 40% of patients with a history of CNS metastases 
  • Compelling activity in T790M-negative disease with 37% ORR observed
    57% ORR and 80% DCR in heavily pretreated centrally confirmed plasma-genotyped T790M-positive patients -- may allow for broader testing for mutations in patients ineligible for tissue biopsy 
  • Well-tolerated; only common grade 3 treatment-related adverse event observed is hyperglycemia 
  • Breakthrough Therapy designation granted by the U.S. FDA; U.S. and E.U. regulatory submissions to complete in July 2015

2:16 am Gilead Sciences reports Zydelig in combination with ofatumumab improves progression-free survival in previously-treated patients with chronic lymphocytic leukemia (GILD) : Co announced results from the Phase 3 clinical Study 119 of an investigational use of Zydelig in combination with ofatumumab in previously-treated patients with chronic lymphocytic leukemia. In Study 119, there was a 73% reduction in the risk of disease progression or death in patients receiving Zydelig in combination with ofatumumab compared to ofatumumab alone

  • The primary endpoint was progression-free survival, defined as the time from randomization to definitive disease progression or death assessed by an independent review committee. 
  • Median PFS in the Zydelig/ofatumumab arm was 16.3 months, compared to 8.0 months in the ofatumumab monotherapy arm. Statistically significant improvements were also observed for overall response rate (75% vs. 18%) and lymph node response rate (93.3% vs. 4.9%). 
  • Median PFS in the approximately 40% of patients with 17p deletion or TP53 mutation was 13.7 months vs. 5.8 months. 
  • A statistically significant difference was not achieved in median overall survival (20.9 months vs. 19.4 months).

2:13 am Ariad Pharm announces long-term safety and efficacy data of ponatinib in chronic-phase chronic myeloid leukemia from Phase 1 Clinical Trial (ARIA) : Co announced long-term follow-up data from the Phase 1 trial of Iclusig, its approved BCR-ABL inhibitor, in heavily pretreated patients with resistant or intolerant chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia. With a median follow-up of over four years (53.1 months), Iclusig continues to demonstrate anti-leukemic activity in chronic-phase CML patients with limited treatment options.

  • Overall, 72% of CP-CML patients achieved a major cytogenetic response on trial, 65% a complete cytogenetic response and 56% a major molecular response. 
  • Long-term safety data on ponatinib indicate that benefit-risk evaluations should guide decisions to initiate and maintain therapy, particularly in patients who may be at increased risk for arterial occlusive events.

2:10 am AbbVie presents results from Phase 1 studies of investigational compound venetoclax in patients with multiple myeloma (ABBV) : Co announced that results from a Phase 1b trial of investigational venetoclax, a novel inhibitor of the B-cell lymphoma-2 protein that is being developed in partnership with Genentech and Roche (RHHBY), in combination with bortezomib and dexamethasone, showed an 83% overall response rate in bortezomib-naive patients with relapsed/refractory multiple myeloma, including two patients who achieved complete responses.

  • Phase 1 studies evaluating safety and pharmacokinetics of venetoclax in relapsed/refractory multiple myeloma
  • Combination study of venetoclax with bortezomib and dexamethasone showed 83% overall response rate in bortezomib-naive patients and a 63% overall response rate in bortezomib-sensitive patients
  • Monotherapy study of venetoclax showed a 29% overall response rate

2:07 am Amgen initiates Phase 3 study evaluating once-weekly Kyprolis (AMGN) : Co announced the initiation of the ARROW trial, a global Phase 3 study evaluating the benefit of Kyprolis for Injection administered once-weekly with dexamethasone versus the current FDA approved twice-weekly administration schedule in patients with relapsed and refractory multiple myeloma who have received prior treatment with bortezomib and an immunomodulatory agent.

  • The most common hematologic treatment-emergent adverse events (AEs) of any grade were anemia (24%), thrombocytopenia (22%) and neutropenia (8%). 
  • The most common non-hematologic treatment-emergent AEs of any grade were fatigue (52%), nausea (35%), headache and diarrhea (31% each). 
  • The most commonly occurring grade =3 hematologic treatment-emergent AEs were thrombocytopenia (6%), anemia (5%) and neutropenia (4%).

2:05 am Publicis acquires Relaxnews for EUR9.58 per share (PUBGY) : Co announces following the exclusive negotiations announced on February 16, 2015 and the completion of the conditions precedent stipulated in the offer of Publicis Groupe, Financire Relaxnews, a special vehicle created for the purpose of the transaction and 100% owned by Publicis Groupe, and the main shareholders of Relaxnews announce the signing of the definitive agreements for the takeover of Relaxnews by Financire Relaxnews.

  • Pursuant to the terms of the definitive agreements, Financire Relaxnews purchased more than 94% of the share capital and voting rights in Relaxnews by way of: 
    • contributions in kind to Financire Relaxnews made by co-founders Jrme and Pierre Doncieux and Habert Dassault Finances representing approximately 30% of the company's share capital enabling them to hold approximately 30% of the share capital of Financire Relaxnews, the remaining 70% being owned by Publicis Groupe
    • the acquisition of a block of shares in Relaxnews representing approximately 30% of the company's share capital at a price of 9.58 euro per share from Jrme and Pierre Doncieux and Habert Dassault Finances
    • the acquisition of a block of shares representing approximately 34% of the company's share capital at a price of 9.58 euro per share from other minority shareholders

2:01 am Koninklijke Ahold repurchased 426,000 Ahold common shares in the period from May 25-29, 2015 (AHONY) : The shares were repurchased at an average price of 18.7658 per share for a total consideration of 7.99 million. These repurchases were made as part of the 500 million share buyback program announced on February 26, 2015.

2:00 am Cypress Semi sends letter to Board of Integrated Silicon Solution (ISSI); states revised proposal is a 'Superior Proposal' (CY) : Cypress Semi (CY) announced that it sent the following letter to the Board of Directors of
Integrated Silicon Solution (ISSI). (The following is a partial of the original)

"On behalf of Cypress Semiconductor Corporation, I am writing to formally convey our proposal to acquire 100% of the outstanding shares of common stock of Integrated Silicon Solution, for $20.25 per share in cash. The board of directors of Cypress has approved this proposal. Our proposal is superior to the $20.00 per share sale price ISSI announced earlier today.

Cypress's revised proposal is a "Superior Proposal" for several reasons:

  • The per share merger consideration being offered by Cypress is $0.25 higher than the merger consideration proposed by the consortium, leading to far greater value for the stockholders of ISSI. 
  • The attached Merger Agreement does not contain any financing conditions and includes a representation and warranty by Cypress that it will have all the funds available as and when needed to consummate the merger. 
  • As the merger positions Cypress to innovate and compete with full service global memory chip manufacturers, this is a pro-competitive merger between complementary companies. Notwithstanding the pro-competitive nature of the merger, we have taken additional steps to address any concerns as to our ability to consummate the transaction..."

1:59 am Tokai Pharma presents protocol and rationale for ARMOR3-SV; remains on track to begin 2Q 2015 (TKAI) : Co announced a poster presentation outlining the design and rationale for ARMOR3-SV, the planned pivotal Phase 3 trial of galeterone in AR-V7 positive castration-resistant prostate cancer patients.

  • ARMOR3-SV is Tokai's planned pivotal Phase 3 clinical trial that will compare galeterone to Xtandi in 148 metastatic CRPC treatment-nave patients whose prostate tumors express the AR-V7 splice variant, which is a truncated form of the androgen receptor. 
  • These truncated ARs are missing the C-terminal end of the receptor that contains the ligand binding domain, which is known as C-terminal loss. 
  • The primary endpoint of ARMOR3-SV will be radiographic progression-free survival, measured from the time of patient randomization to the time of radiographic evidence of disease progression or time of death from any cause. 
  • Tokai plans to begin ARMOR3-SV in the second quarter of 2015, with topline data expected by the end of 2016.

1:57 am Juno's investigational CAR T cell product candidate JCAR015 demonstrates encouraging clinical responses in patients with B-Cell Cancers (JUNO) : Co announced today that clinical data from its most advanced chimeric antigen receptor T cell product candidate, JCAR015, demonstrated encouraging clinical responses in acute lymphoblastic leukemia.

  • Complete remission was reported in 33/38 (87%) of evaluable patients and minimal residual disease (MRD) negative CR was reported in 26/32 (81%) of patients who achieved a CR. 
  • Median overall survival for all efficacy evaluable patients (N=38) was 8.5 months, and the 6 month OS rate was 59% (95% CI: 39-74). 
  • Durable responses were observed in patients with and without subsequent allogeneic stem cell transplant. 
  • Severe cytokine release syndrome was observed in 9/39 (23%) of patients. Severity of CRS correlated with disease burden and was generally reversible.
  • Grade 3/4 neurotoxicity was observed in 11/39 (28%) of patients. Grade 5 toxicity was observed in 3/39 (8%) of patients, and assessed to be unrelated to JCAR015 treatment in one of these patients.

1:52 am OncoGenex Pharma presents data from the Phase 3 SYNERGY trial showing a survival benefit with custirsen in patients with poor prognosis (OGXI) : Co announced that results from a retrospective analysis of the Phase 3 SYNERGY trial showed a benefit with custirsen therapy in men with metastatic castrate-resistant prostate cancer who had a poor prognosis.

  • The analysis, exploring the effect of clusterin inhibition in men at risk for poor outcomes, showed that over 40% of men in the trial had at least two of five common risk factors for poor prognosis. 
  • In these men, the analysis found a 27% lower risk of death when custirsen was used in combination with first-line docetaxel compared to docetaxel alone.

1:36 am On The Wires (:WIRES) :

  • California Water Service's Schedule 14.1 filing, which establishes household and business water budgets and associated enforcement measures in order to achieve state-mandated water use reductions necessitated by historic drought conditions, will become effective on June 1, 2015, after a 30-day review by the California Public Utilities Commission. California Water Service is the largest subsidiary of California Water Service Group (CWT). 
  • TESARO (TSRO) and Merck (MRK) announced a collaboration to evaluate the combination of TESARO's niraparib plus Merck's anti-PD1 therapy, KEYTRUDA, in a Phase 1/2 clinical trial. 
  • ARM (ARMH) has unveiled a new hardware subsystem to enable the fast and efficient development of highly customized chips for smart connected devices. The ARM IoT subsystem for ARM Cortex-M processors is optimized for use with ARM's most efficient processor and radio technologies, physical IP and ARM mbed OS.
  • Intelsat S.A. (I) and BT Group (BT) confirmed that BT has renewed and expanded services on three Intelsat satellites, spanning the Asia-Pacific, Africa and Latin America regions. 
  • Rayonier Advanced Materials (RYAM) announced that it has entered into a non-binding letter of intent with Borregaard ASA to form a joint venture at its Fernandina Beach facility for the manufacturing, marketing and sale of natural lignin-based products. The new company will be owned 45 percent by RYAM and 55 percent by Borregaard.
  • JD.com (JD) announced the launch of Japanese Mall, a new channel on the company's JD Worldwide cross-border platform dedicated exclusively to sales of authentic imported Japanese products. 
  • Sobi, a specialty life sciences company dedicated to rare diseases, has selected Veeva (VEEV) Commercial Cloud to support its global commercial organisation across sales, marketing, and medical.  

1:18 am VBL Therapeutics presents positive interim results from an investigator-initiated, Phase 1/2a trial of multiple dose VB-111 (VBLT) : Co announced positive interim results from an investigator-initiated, Phase 1/2a trial of multiple dose VB-111 in recurrent platinum-resistant Mllerian (ovarian) cancer. The data demonstrated promising evidence of clinical benefit in patients with recurrent platinum-resistant Mllerian cancer who received VB-111 in conjunction with weekly paclitaxel.

  • In this study, VB-111 was safe and well tolerated in combination with paclitaxel, with anticipated toxicities. The most frequent adverse events observed in the study were low-grade flu-like symptoms.
  • This Phase 1/2a trial, run by Massachusetts General Hospital and Dana Farber Cancer Institute, was an open-label, dose-escalating study designed to determine the safety and tolerability of the combination of intravenous administration of VB-111 and paclitaxel in patients with platinum-resistant Mllerian cancer.

1:17 am XPO Logistics raises a total of $1.26 bln of equity from group of global institutional investors (XPO) : Co announced that it has entered into definitive agreements with a group of global institutional investors to raise a total of $1.26 billion of equity. The company will receive all of the net proceeds and will use them to fund its ongoing growth strategy.

  • The transaction, which is complete and scheduled to settle this week, provides for the sale of newly issued common stock and preferred stock to the investors at a price of $45 per share of common stock on an as-converted basis. 
  • Upon approval by the company's shareholders, the preferred stock will be converted into common stock. 
  • The stock issuance represents 28 million shares, or approximately 21% of XPO's common stock on a fully diluted basis, assuming conversion of the preferred stock.

1:15 am Clovis Oncology's Phase 2 studies of rucaparib in ovarian cancer demonstrate highly compelling clinical activity, in both BRCA-mutant and BRCA-like patients (CLVS) : Co announced updated Phase 2 results from two ongoing clinical studies with rucaparib: ARIEL2 and Study 10. Rucaparib is the Company's investigational oral, potent, small molecule inhibitor of PARP1 and PARP2 being developed for the treatment of advanced ovarian cancer, specifically in patients with BRCA mutations and other DNA repair deficiencies beyond BRCA, commonly referred to as "BRCA-like."

  • Data from ARIEL2 in platinum-sensitive BRCA-mutant patients demonstrated an overall response rate (ORR.V) of 82%, a disease control rate (:DCR) of 94% and a median progression-free survival of 9.4 months 
  • Complete responses observed in 10% of patients 
  • Data from ARIEL2 in patients with BRCA-like signature demonstrated ORR of 45% and DCR of 73% in and a median PFS of 7.1 months 
  • In ARIEL2, approximately 60% of patients treated to date exhibit BRCA-mutant status or BRCA-like DNA signature 
  • Data from Study 10, a Phase 2 study of heavily pretreated germline BRCA-mutant ovarian cancer patients, demonstrated an ORR of 74% 
    • 77% ORR observed in patients treated with at least three prior lines of chemotherapy; median duration of response in these patients is currently greater than 11 months 
  • 74% ORR, median duration of response greater than 11 months observed in 23 BRCA-mutant patients treated with at least three prior lines of chemotherapy from ARIEL2 and Study 10 combined 
    • CRs observed in 13% of patients in this group 
  • Enrollment in ARIEL2 Part 2 single-arm study in heavily pre-treated patients (=3 prior lines of chemotherapy) continues with planned NDA submission in 2016 
  • Data presented at ASCO demonstrate that rucaparib is well-tolerated with a manageable safety profile. The most common grade 3/4 treatment-related adverse events were anemia/decreased hemoglobin, fatigue, nausea and transient ALT/AST elevations 
  • Only PARP inhibitor to be granted Breakthrough Therapy designation by the FDA 

1:13 am Immunogen Mirvetuximab Soravtansine demonstrates notable single agent activity for patients with platinum-resistant ovarian cancer (IMGN) : Co announced the presentation at ASCO Annual Meeting of the first clinical findings in a disease-specific patient population with the Company's unique, FRa-targeting ADC, mirvetuximab soravtansine.

  • Twenty-two patients were included in the analysis reported today -- two from the dose-escalation phase of the trial and the twenty enrolled in the expansion cohort at the time of data cutoff for presentation. 
  • All had FRa-positive platinum-resistant ovarian cancer and had received mirvetuximab soravtansine at the RP2D (6.0 mg/kg, given every three weeks). All had previously received taxane as well as platinum therapy. Thirteen were still on study at the time of data cutoff. 
  • The majority of adverse events reported were low grade (grade 1 or 2), with diarrhea, blurred vision, nausea, vomiting, fatigue, and abdominal pain the most common treatment-emergent events reported (>20% of patients). 
  • Seventeen of the 22 patients were included in the efficacy analysis; the other five patients were still on study and had not yet reached their first assessment.

1:09 am Manpower acquires Greythorn; terms not disclosed (MAN) : Co announced its acquisition of the Australian and Singapore arm of Greythorn, a leading professional services and recruitment firm specialising in technology and finance. With this acquisition, Greythorn and its banking and finance subsidiary Marks Sattin, become wholly owned by ManpowerGroup Australia, operating under the Experis brand.

12:43 am Adaptimmune Therapeutics presents data from clinical studies of NY-ESO-1 specific T-Cells in multiple cancers (ADAP) : Co announced a poster presentation of data on its lead clinical program, an affinity enhanced T-cell receptor therapeutic targeting the NY-ESO-1 cancer antigen, in both solid and hematologic cancers. Eighty-two (82) patients have been treated to date with NY-ESO-T; 44 under Adaptimmune's IND, and 38 under a National Cancer Institute IND
The authors of the poster concluded:

  • NY-ESO-T demonstrated robust clinical responses in solid and hematologic tumors, including a 60 percent (6/10) confirmed response rate in synovial sarcoma, and a 59 percent (13/22) response rate (Complete Response + near Complete Response, per International Myeloma Working Group guidelines) in myeloma in the context of autologous stem cell transplant. Approximately 62 percent (8/13) of responders had tumors with abnormal cytogenetics; 4/8 of these abnormalities are associated with high risk disease.
  • In addition, a response was seen in an initial ovarian patient and patient's tumor markers were observed to be falling during this period of response. The response was abrogated by the use of systemic steroids to treat cytokine release syndrome. Reduction in pre-conditioning chemotherapy intensity in the subsequent four ovarian patients was associated with short T-cell persistence and lack of a meaningful antitumor effect. New studies are being conducted to identify the optimal dosage of pre-conditioning chemotherapy for NY-ESO-1 T-cell function.
  • Durability of response ranged from 2 to 9 months, and from 3 months to ongoing response at 2.5 years in the sarcoma and myeloma studies respectively.
  • NY-ESO-T has been generally well-tolerated with no long term side-effects detected to date. In the 44 patients treated under the Adaptimmune IND, the most common adverse events include diarrhea, pyrexia, and fatigue. Grade 3 cytokine release syndrome was observed in two patients, which was manageable with supportive care measures and resolved without sequelae. 
Importantly, NY-ESO-1 T-cells exhibited durable persistence without the requirement for IL-2 support in vivo, and cells were detectable for up to three years in peripheral blood by PCR. Additionally, the data show continued expression of the NY-ESO TCR for up to two years and continued NY-ESO-T function in a subset of patients, without accumulation of multiple exhaustion markers. NY-ESO-T memory phenotype is generated in persisting cells suggesting the programming of immunological memory for NY-ESO-T.

12:40 am AstraZeneca and MedImmune present positive immuno-oncology combination (AZN) : AstraZeneca (AZN) and MedImmune, AstraZeneca's global biologics research and development arm.

  • Overall, data indicated clinical activity with manageable safety profiles for the anti-programmed cell death ligand 1 monoclonal antibody MEDI4736, both as monotherapy and in combination with other immuno-oncology and small molecule therapies across different tumor types and tumor biology. 
  • MEDI4736 and tremelimumab combination shows clinical activity and tolerability in both PD-L1 positive and PD-L1 negative advanced non-small cell lung cancer patients; dose confirmed for future studies 
  • Results from the combination study of MEDI4736 and tremelimumab, a cytotoxic T-lymphocyte-associated protein-4 monoclonal antibody, in the treatment of advanced NSCLC, demonstrated clinical activity in heavily-pretreated patients with a manageable safety profile, establishing appropriate doses to move forward into Phase III combination trials.

12:34 am MacroGenics presents updated data from Phase 1 Study of Margetuximab at ASCO; data show signs of clinical activity for Margetuximab in HER2-expressing tumors (MGNX) : Co announced that updated results of the Phase 1 study of margetuximab were reported during a poster session at ASCO.
Study Results

  • This open-label, multi-dose, single-arm, multi-center Phase 1, dose-escalation study was conducted in 60 patients with HER2-positive neoplasms, including 23 with breast cancer, and was aimed at defining the toxicity profile, maximum tolerated dose, pharmacokinetics, immunogenicity and potential anti-tumor activity of margetuximab.
  • Margetuximab was administered by IV infusion once per week for 4 weeks in the following dose escalation cohorts: 0.1, 0.3, 1.0, 3.0, and 6.0 mg/kg; and once every 3 weeks in the following dose escalation cohorts: 10.0, 15.0, and 18.0 mg/kg. 
  • Study results showed that margetuximab was well-tolerated at all explored doses, including the highest dose tested. Infusion reactions were generally mild overall and were well controlled with pre-medication.

12:32 am Oncothyreon presents positive ONT-380 data in HER2-positive breast cancer at ASCO (ONTY) : Co announced the presentation of positive data from the company's ongoing trials of ONT-380, an orally active, reversible and selective small-molecule HER2 inhibitor for the treatment of breast cancer, at the American Society of Clinical Oncology.

  • The first presentation updated data from the Phase 1b trial of ONT-380 in combination with Xeloda and Herceptin in third line treatment of HER2-positive metastatic breast cancer. 
  • The data support Oncothyreon's plans to initiate a blinded, randomized, placebo-controlled Phase 2 trial in this indication. 
  • The second presentation focused on the role of ONT-380 in the treatment of HER2-positive breast cancer central nervous system metastases.

12:28 am Calithera Biosciences reports Phase I data for CB-839 in patients with solid tumors; data support initiation of multiple solid tumor expansion cohorts (CALA) : Calithera Biosciences (CALA) announced that data from its lead, first-in-class program CB-839 was presented at ASCO. The data demonstrate the clinical activity, tolerability and unique mechanism of action of CB-839 in patients with solid tumors.

  • The data demonstrated stable disease in a variety of solid tumor types. Two triple negative breast cancer patients and one renal cell carcinoma patient had prolonged stable disease 323, 218, and 240 days respectively, and remain on study. 
  • One of the TNBC patients demonstrated a 23% reduction in target lesions. In the cohort dosed twice daily with food, 7 out of 17 (41%) of response-evaluable patients had stable disease as their best overall radiographic response, and in the dose escalation cohort on the three times daily schedule 6 out of 31 (19%) response-evaluable patients had stable disease as their best overall radiographic response. 
  • It was observed that BID dosing with meals provides the optimal pharmacokinetic and safety profile for CB-839.

12:25 am AbbVie and Pharmacyclics (PCYC) reports Phase III HELIOS study results show ibrutinib; significantly increased progression-free survival in previously-treated chronic lymphocytic leukemia/small lymphocytic lymphoma patients (ABBV) : Pharmacyclics LLC announced the results of the Phase III HELIOS trial (CLL3001), which found that patients with previously treated chronic lymphocytic leukemia (CLL.TO) or small lymphocytic lymphoma who received ibrutinib (:IMBRUVICA) in combination with bendamustine and rituximab experienced an 80% reduction in the risk of progression or death compared to patients receiving placebo in combination with BR. Patients also experienced a higher overall response rate (ORR, a key secondary endpoint), including achieving a higher rate of complete responses (CR), after a median follow-up of 17 months.

  • PFS was the primary endpoint of the study, as assessed by an independent review committee. At 18 months, IRC-assessed PFS rates were 79% for patients in the ibrutinib+BR arm compared with 24% for patients in the placebo+BR arm. Key secondary endpoints included IRC-assessed ORR and overall survival. At a median follow-up of 17 months, PFS was significantly longer with ibrutinib+BR versus placebo+BR (median not reached vs. 13.3 months). 
  • Patients with the genetic mutation del 17p CLL were excluded from the study, but PFS rates were consistent across all other high-risk subgroups. 
  • Patients in the ibrutinib+BR arm experienced higher rates of ORR and CR/CRi (CR with incomplete hematopoietic recovery), 82.7% and 10.4%, respectively, compared to patients in the placebo+BR arm, 67.8% and 2.8%, respectively. 
  • The median OS has not yet been reached after a median follow up of 17 months.

12:21 am CTI BioPharma presents Phase 3 pacritinib study showing significant clinically meaningful results in patients with myelofibrosis (CTIC) : CTI BioPharma (CTIC) and Baxter International's Bioscience business (BAX) today announced data from PERSIST-1 -- a randomized Phase 3 registration-directed trial examining pacritinib for the treatment of myelofibrosis.

  • Study demonstrates improvement in key disease measurements and disease-related symptoms with pacritinib treatment compared to best available therapy, regardless of platelet levels at the time of enrollment
  • Treatment resulted in improvements in severe thrombocytopenia and severe anemia, eliminating the need for blood transfusions in a quarter of patients who were transfusion dependent at the time of enrollment

12:19 am Pfizer announces palbociclib more than doubled progression-free survival in Phase 3 trial for patients with HR (PFE) : Co announced study results demonstrating palbociclib in combination with fulvestrant was superior to treatment with a standard of care, fulvestrant, by significantly extending progression-free survival in women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer whose disease has progressed during or after endocrine therapy (HR 0.42, median PFS, 9.2 vs. 3.8 months, in their respective arms.

  • Based on the results of PALOMA-3, Pfizer is in discussions with global regulatory authorities to determine next steps to potentially make palbociclib available for women with HR+, HER2- metastatic breast cancer whose disease has progressed following endocrine therapy. 
  • As previously disclosed, Pfizer intends to file a Marketing Authorisation Application for palbociclib to the European Medicines Agency in the second half of 2015. In addition, Pfizer will work closely with the FDA to review these data and determine next steps for potential inclusion in the U.S. label.

12:15 am Exelixis presents updated positive results from two trials of cobimetinib in combination with vemurafenib for the treatment of patients with advanced melanoma (EXEL) : Exelixis announced updated positive results for cobimetinib, an Exelixis-discovered investigational compound, in combination with vemurafenib for the treatment of patients with previously untreated BRAF V600 mutation-positive advanced melanoma. Updated data from coBRIM, the phase 3 pivotal trial conducted by Exelixis' collaborator Genentech, a member of the Roche Group, showed the combination helped patients with previously untreated BRAF V600 mutation-positive advanced melanoma live a median of one year (12.3 months) without disease progression or death, compared to 7.2 months with vemurafenib alone. Data from a second trial, the phase 1b BRIM7 study, showed that treatment with the combination resulted in a median overall survival of more than two years (28.5 months) for patients without prior BRAF inhibitor treatment.

  • Updated results from coBRIM phase 3 pivotal trial show median progression-free survival of one year for patients with BRAF V600 mutation-positive advanced melanoma
  • Additional data from phase 1b BRIM7 study showed 61 percent of patients who had not been previously treated with a BRAF inhibitor were alive after two years
  • Cobimetinib for use in combination with vemurafenib is the subject of pending U.S. and European regulatory applications, with U.S. PDUFA date of August 11, 2015

12:13 am Roche Hldg provides updated data showing Genentech's investigational combination of cobimetinib and zelboraf helps people with advanced melanoma live for a year without their disease worsening (RHHBY) : Genentech, a member of the Roche Group (RHHBY), announced follow-up data from two studies of the investigational MEK inhibitor cobimetinib in combination with Zelboraf. Updated data from the pivotal coBRIM Phase III study showed the combination helped people with previously untreated BRAF V600 mutation-positive advanced melanoma live a median of one year (12.3 months) without their disease worsening or death compared to 7.2 months with Zelboraf alone

  • The updated results from coBRIM also demonstrated higher response rates with cobimetinib and Zelboraf compared to Zelboraf alone. The objective response rate with the combination was 70% (16% complete response, 54% partial response) compared to 50% (11% CR, 40% PR) in the Zelboraf arm. With further follow-up, the complete response rate increased from 10% to 16% with the combination as some patients who had a partial response achieved a complete response after more than one year of treatment. 
  • The safety profile of cobimetinib and Zelboraf was consistent with safety data previously reported.

12:10 am Roche Hldg's unit Genentech's Gazyva extended the time people with refractory indolent Non-Hodgkin's lymphoma lived without their disease worsening (RHHBY) : Genentech, a member of the Roche Group (RHHBY), announced results from the Phase III GADOLIN study showing that Gazyva plus bendamustine followed by Gazyva alone provided significant benefit for people with indolent non-Hodgkin's lymphoma that is refractory to Rituxan-based treatment. In the study, Gazyva plus bendamustine followed by Gazyva alone reduced the risk of disease worsening or death by 45%, compared to bendamustine alone.

  • The study was stopped prior to its protocol-specified final analysis due to the high level of benefit seen in the Gazyva arm compared to the bendamustine arm. There were no unexpected safety signals identified with Gazyva. 
  • No unexpected safety signals were identified in the Gazyva-based treatment arm. 
  • Grade 3-4 adverse events that occurred in at least two% of patients in the Gazyva-treated group or bendamustine alone group included low white blood cell count (33% vs. 26.3%), low blood platelet count (10.8% vs. 16.2%), infusion-related reactions (10.8% vs. 5.6%), low red blood cell count (7.7% vs. 10.1%), low white blood cell count with fever (4.6% vs. 3.5%), nausea (1% vs. 3%), fatigue (1.5% vs. 2.5%), diarrhea (1% vs. 2.5%), vomiting (2.1% vs. 1%), respectively. 

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United States Steel Corporation

CODE : X
ISIN : US9129091081
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United States Steel is a iron and tin producing company based in United states of america.

United States Steel is listed in United States of America. Its market capitalisation is US$ 7.2 billions as of today (€ 6.3 billions).

Its stock quote reached its lowest recent point on March 28, 2003 at US$ 10.01, and its highest recent level on November 30, 2007 at US$ 98.85.

United States Steel has 176 184 431 shares outstanding.

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