Plug Power.

Published : November 09th, 2015

7:11 am Plug Power misses by $0.01, beats on revs

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7:11 am Plug Power misses by $0.01, beats on revs

8:57 am On The Wires (:WIRES) :

  • Orbital ATK, Inc. (OA) established an affiliate in the Emirate of Abu Dhabi to support the company's growing regional defense business.
  • Medidata (MDSO) prevailed in defending a patent lawsuit filed by Datatrak International (DTRK) in March 2011.
  • Apple (AAPL) announced iPad Pro is available to order online on Wednesday, November 11, from Apple.com and will arrive at Co's retail stores, select carriers and Apple Authorized Resellers starting later this week. Apple Pencil and Apple's new Smart Keyboard, also available to order on Wednesday.
  • myTomorrows announced that it has recently signed a contract to collaborate with Hemispherx Biopharma (HEB) to provide access to its natural alpha interferon for patients that have become intolerant to treatment with recombinant interferon or where such treatment fails.
  • St. Jude Medical, Inc. (STJ) announced analysis shows that after moving from standard HF therapy to management based on information from the CardioMEMS HF System, patients from the study's control group had a 48 percent reduction in HF hospitalizations.
  • Fairmount Santrol (FMSA) announced a successful six-well field trial using its proprietary Propel SSP proppant transport technology. Initial 90-day oil production increased 39% compared with offset wells. The production increase can be attributed to an increase in the propped surface area. In addition to the oil production increase, Propel SSP simplified hydraulic fracturing operations by reducing fluid additive consumption by 77% and pumping time by 14%.
  • Crossroads Systems, Inc. (CRDS) announced that Oper8 Pty Ltd is its first reseller partner in Australia for its StrongBox network-attached storage solution.
  • Cancer Genetics, Inc. (CGIX) entered into in-network provider agreements with Blue Cross Blue Shield of North Carolina, Blue Cross Blue Shield Nebraska, and WellMark, Inc. The agreement will allow members of these networks access to Co's cancer diagnostic services.

8:56 am S&P futures vs fair value: -5.70. Nasdaq futures vs fair value: -11.60. (:WRAPX) :

The S&P 500 futures trade six points below fair value.

The Asian equity markets closed mixed today. Starting in China, the Shanghai Composite posted a 1.6% gain today. The Mainland reported the day's most significant data point with the release of its October Trade Balance, which came in below expectations at $61.50 bln (expected $62.20 bln), but represented the largest trade surplus in nearly 20 years. However the underlying components proved to be weaker than expected with exports falling 6.9% (expected -3.8%), and imports dropping 18.8% (expected 15.0%). The weaker than expected data did not seem to impact the equities nearly as much as it has in the past. This may be attributed to local reports that the CSRC is set to ramp up IPO launches again, which implies relative confidence that the equity markets have stabilized. In Japan, the weakness in the yen following the NFP data on Friday help the Nikkei post a 2% gain on the session. USDJPY hit the highest level in 3 months, topping off at 123.60. Exporters were notably higher in response.

  • In economic data:
    • China's October trade surplus $61.64 billion (expected $64.75 billion; prior $60.34 billion) as exports -6.9% (consensus -3.0%; prior -3.7%) and imports -18.8% (expected -16.0%; last -20.4%)
    • Japan's Average Cash Earnings +0.6% year-over-year (consensus 0.5%; prior 0.4%) and September Overtime Pay +1.4% year-over-year (last 1.5%)
    • Australia's ANZ Job Advertisements +0.4% month-over-month (last 3.8%)

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  • Japan's Nikkei increased 2.0%, led by the Consumer Discretionary sector (+2.6%) which saw benefit from the yen's weakness and the better than expected NFP data. Utilities (-0.5%) was the only sector under water for the session. Automakers were also stronger today after Isuzu Motors (+3.3%) and Yamaha Motor (+3.9%) both posted better than expected earnings results.
  • Hong Kong's Hang Seng declined 0.6%. Leading the way lower were energy names and telecoms. Among the market laggards were CNOOC (-2.5%), while Sinopec and PetroChina slipped 1.5%. Meanwhile, China Unicom fell 2.1%.
  • China's Shanghai Composite finished 1.6% higher today with brokerage stocks being the beneficiary of the reports that IPOs would be set to begin again. As such, CITIC Securities and China Galaxy Securities both closed up 2.1%. Another stand out was CICC, which closed up +9.5% after the company began trading today following its IPO.

Major European indices trade lower across the board with France's CAC (-0.4%) trailing the region. Elsewhere, the Eurogroup is expected to withhold a EUR2.00 billion bailout payment for Greece due to a disagreement over foreclosure rules. On a separate note, Portuguese equities have faced some selling pressure amid expectations that a new alliance between opposition socialists and other far left parties will bring down the recently-formed center-right government. The PSI 20 is down near 3.0% in Lisbon.

  • Economic data was limited:
    • Eurozone November Sentix Investor Confidence 15.1 (expected 13.2; last 11.7)
    • Germany's September trade surplus EUR19.40 billion (expected EUR20.00 billion; previous EUR19.60 billion) as exports +2.6% (consensus 2.1%; prior -5.2%) and imports -3.6% (expected 0.9%; last -3.2%)

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  • UK's FTSE hovers just below its flat line with consumer names on the defensive, InterContinental Hotels, Taylor Wimpey, and Unilever show losses between 1.3% and 3.5%. On the upside, financials outperform with Aberdeen Asset Management, Barclays, Standard Chartered, and HSBC showing gains between 1.1% and 2.6%.
  • Germany's DAX is lower by 0.2% with Continental leading the retreat. The stock has surrendered 5.2% in reaction to disappointing results. Drugmakers also lag with Bayer and Merck down 0.9% and 0.5%, respectively. On the upside, Thyssenkrupp has climbed 3.7%.
  • In France, the CAC trades down 0.4%. Renault is the weakest performer, down 2.3%, while financials BNP Paribas and Societe Generale outperform with losses of 0.2% apiece. Elsewhere, ArcelorMittal has spiked 4.1%.

8:51 am Network-1 announces a settlement with Microsoft (MSFT) for infringement of its '227 patent; Network-1 will receive a $4.65 mln payment (NTIP) :

Co announced that its wholly-owned subsidiary, agreed to settle its patent litigation against Microsoft Corporation (MSFT) pending in the United States District Court for the Eastern District of Texas, for infringement of its '227 patent.

  • Under the terms of the agreement, Microsoft will license the '227 for its full term, which expires in 2016, and will receive a fully paid up license, which covers Microsoft's products. Microsoft customers will also be covered under the license to the '227 Patent. Network-1 will receive $4,650,000 from Microsoft for the settlement and fully paid up license.

8:51 am Gapping down (SCANX) : Gapping down
In reaction to disappointing earnings/guidance
: KNDI -12%, PLUG -8.3%, NVAX -6.8%, PCLN -5.9%, EVEP -4.8%, AOI -3%, ANTH -3%, BITA -2.8%, MNKD -2.4%, FXEN -0.9%

M&A news: WY -3.7% (Weyerhaeuser and Plum Creek (PCL) to merge; all-stock transaction followed by $2.5 bln post-closing share repurchase; WY to review strategic alternatives for its Cellulose Fibers business)

Select large pharma names showing weakness: SNY -2.1%, AZN -1.7%, SHPG -1.6%, NVS -1%, GSK -0.5%

Other news: XOMA -8.9% (cont weakness), NBG -5.3% (still checking), AGIO -5.1% (reports data from dose-escalation Phase 1 study of AG-120), ITUB -2.5% (still checking), CALA -2.4% (reports new Phase 1 solid tumor dose expansion data of CB-839), BHP -1.3% (updates on the incident at its Samarco mine, places FY16 production guidance under review)

Analyst comments: GLUU -4.3% (downgraded to Hold at The Benchmark Company), CENX -2.2% (downgraded to Neutral from Buy at Nomura), SNY -2.1% (downgraded to Mkt Perform from Outperform at Bernstein), OVAS -1.9% (downgraded to Mkt Perform from Outperform at Leerink Partners), ADSK -1.5% (downgraded to Neutral from Buy at UBS ), SSYS -1.3% (downgraded to Hold from Buy at Deutsche Bank), CTIC -0.8% (downgraded to Hold at WallachBeth), AA -0.7% (downgraded to Neutral from Buy at Nomura), QCOM -0.6% (downgraded to Neutral from Buy at Nomura).

8:50 am General Electric receives Letter of Award from India's Ministry of Railways for a locomotive supply and maintenance contract worth ~$2.6 bln over 11 years (GE) : GE will invest $200 million to develop and supply Indian Railways with 1,000 diesel locomotives.

8:45 am Gapping up (SCANX) : Gapping up
In reaction to strong earnings/guidance
: ACI +26.5%, PGN +12.5%, AVEO +12.2%, RXDX +8.5%, DF +7.8%, HZNP +6.1%, ICON +5.8%, SNI +4.2%, INO +4%, RLD +3.6%, NSAM +2.5%, CTCM +2.4%, ENDP +1.9%, EXXI +1%

M&A news: PCL +14% (Weyerhaeuser and Plum Creek (PCL) to merge; all-stock transaction followed by $2.5 bln post-closing share repurchase; WY to review strategic alternatives for its Cellulose Fibers business)

Select metals/mining stocks trading higher: RGLD +1.4%, RIO +0.9%, SSRI +0.7%, AEM +0.7%, KGC +0.6%, GG +0.5%

Select oil/gas related names showing strength: APA +12.9% (still checking),RIG +2.3% (still checking),SDRL +2.2% (still checking),OAS +2% (still checking),STO +1.8% (still checking),NBL +1% (still checking),RDS.A +0.8% (still checking)

Other news: AVXL +20.7% (presents positive safety and cognitive efficacy data for ANAVEX 2-73; study met the primary objective of safety),TKAI +13.4% (presents new data highlighting the anti-tumor activity of galeterone in multiple preclinical tumor models),IMNP +9.6% (announces FDA acceptance of its IND application for Bertilimumab, to treat Bullous Pemphigoid; enables expanded recruitment for its clinical trials),RXDX +8.5% (reports interim data from RXDX-105 Phase 1 clinical trial; RXDX-105 was well tolerated to date),WTW +6.3% (cont strength),RDHL +4.5% (RedHill Biopharma and IntelGenx Corp announce that they have been granted marketing approval in Germany, for Rizaport 5mg and 10mg to treat migraines),CRIS +4% (presents preclinical data from oral small molecule PD-L1/VISTA and IRAK4 programs),MT +2.8% (Telegraph discusses that Europe wants China to stop dumping steel output),ERIC +2.2% (Cisco Systems and Ericsson form strategic partnership),COLL +1.8% (announces FDA approval for its NDA for Xtampza ER),GALE +1.7% (reports data from its GALE-301 and GALE-302 clinical programs)

Analyst comments: AEZS +24.6% (upgraded to Buy at Canaccord Genuity),PZZA +3.2% (upgraded to Overweight at KeyBanc)

8:44 am On The Wires (:WIRES) :

  • Judge Karl J. Bemesderfer with the California Public Utilities Commission issued a favorable Proposed Decision proposing approval of Frontier Communication Corp's (FTR) proposed acquisition of Verizon's (VZ) local wireline, broadband and video operations, including the FiOS network. Co expects to close the transaction at the end of 1Q16.
  • CyberOptics Corporation (CYBE) received an order valued at ~ $1.1 mln for 3D MRS-enabled sensor subsystems from an OEM customer. Shipments under this order are expected to commence late in 2015 and continue into 1Q16.
  • Gevo, Inc. (GEVO) entered into a license agreement and a joint development agreement with Praj Industries Limited to enable the licensing of Co's isobutanol technology to processors of non-corn based sugars, including the majority of Praj's global customer base of ethanol plant owners. 
  • Digital Insight, an NCR (NCR) company, and CUneXus Solutions partnered together to resell CUneXus' cplXpress product to Digital Insight financial institution customers.
  • Ingram Micro Inc. (IM) expanded its distribution agreement with Acronis. 

8:41 am Fairmount Santrol announces a successful six-well field trial using its proprietary Propel SSP proppant transport technology (FMSA) :

  • Initial 90-day oil production increased 39% compared with offset wells.
  • In the Three Forks and Middle Bakken formations of North Dakota's Williston basin, Enerplus (ERF) compared six Propel SSP wells with five offset wells that were completed using Northern White sand in a traditional crosslinked gel fluid system. The field test comparison specified the same proppant volume per lateral foot.
  • The production increase can be attributed to an increase in the propped surface area, the area of the hydrocarbon-rich rock that is fractured and successfully held open by proppant.
  • In addition to the oil production increase, Propel SSP simplified hydraulic fracturing operations by reducing fluid additive consumption by 77% and pumping time by 14%. The technology can easily be pumped at high loading rates in a low-viscosity fluid that increases hydraulic fracturing efficiency.

8:40 am Interdigital Comm raises Q4 rev to $89-91 mln vs $86.6 mln two analyst estimate (IDCC) :  

8:35 am EDAP TMS SA announces 501(k) clearance from the FDA for to market Ablatherm Integrated Imaging HIFU for the ablation of prostate tissue (EDAP) : Co announced that it has received 510(k) clearance from the U.S. FDA to market Ablatherm Integrated Imaging HIFU in the U.S. for the ablation of prostate tissue. EDAP expects to commercialize Ablatherm HIFU in the U.S. immediately

8:35 am L.B. Foster misses by $0.06, misses on revs; guides Q4 EPS below two analyst estimate, revs below consensus; Stock is halted (FSTR) :

  • Reports Q3 (Sep) earnings of $0.67 per share, excluding non-recurring items, $0.06 worse than the two analyst estimate of $0.73; revenues rose 4.9% year/year to $176.1 mln vs the $193.28 mln Capital IQ Consensus. 
    • Third quarter bookings were $145.5 million, a 2.2% increase over the prior year third quarter, due to 231.1% and 10.3% increases in Tubular and Construction segment orders, respectively, partially offset by a decline of 31.4% in the Rail segment. The increase in Tubular segment orders was due to orders generated by our recently acquired energy businesses as well as our Coated Products division.
  • Co issues downside guidance for Q4, sees EPS of $0.30 vs. $0.53 two analyst estimate; sees Q4 revs of $150-154 mln vs. $185.13 mln Capital IQ Consensus Estimate. 
    • This forecast represents our current view of the market which is factoring in less favorable year-end spending patterns. It is possible that we could still fall short of this forecast as customers in the upstream market sector consider temporary shutdowns for the last several weeks of the year. We are closely monitoring customer intentions and their potential actions to preserve cash in the final period of the year. If a portion of our customers decide to shutdown or severely cut back on upstream development and production activity, it could have a further $0.10 to $0.20 unfavorable impact on EPS for the quarter.

8:34 am A-Mark Precious Metals names Cary Dickson as CFO (AMRK) : Co appoints Cary Dickson as CFO, effective November 9, 2015. Dickson previously held VP of finance and CFO of Mattel Foundation duties at Mattel Brands (MAT). 

8:34 am Horsehead Holding misses by $0.10, beats on revs (ZINC) :

  • Reports Q3 (Sep) loss of $0.45 per share, excluding non-recurring items, $0.10 worse than the Capital IQ Consensus of ($0.35); revenues fell 3.6% year/year to $106.99 mln vs the $99.73 mln Capital IQ Consensus.
  • "The quarter was adversely affected by a sharp decline in commodity prices, lower EAF dust receipts reflecting weaker steel production and some one-time charges primarily related to inventory and LME-related price adjustments. This was offset partially by a 6% increase in shipments on a zinc-contained basis and a 25% increase in shipments of nickel remelt alloy compared with the prior year's quarter."
  • During Q3, EAF dust tons processed decreased 13.7% YoY and 3.4% sequentially due primarily to reduced receipts. WCo took the opportunity of low dust receipts to take several maintenance related outages during Q3. Given its system-wide inventory of recyclable zinc units, co expects to operate all of its kilns entering Q4 but may idle one or more kilns before the end of the year if steel industry output does not increase.

8:34 am AngioDynamics announces resignation of CFO Mark Frost (ANGO) : The co announced that Mark Frost has resigned as Executive Vice President and Chief Financial Officer and accepted the position of Senior Vice President, Chief Financial Officer and Treasurer at Analogic (ALOG). Frost will remain available to AngioDynamics through November 20 to facilitate a smooth transition of duties. Michael Trimarchi, Vice President and Global Controller, will assume the responsibilities as principal financial officer of the company and will serve as interim CFO. The Company has initiated a search for a permanent successor.

8:34 am Immunomedics announces that patients with metastatic triple-negative breast cancer lived for a median of seven months without tumor progression, after receiving at least 3 doses of sacituzumab govitecan in Phase 2 clinical study (IMMU) :

The study also indicated that the responses were very durable, showing a median time-to-progression, based on computed tomography, of 9.4 months (range of 1.8+ to 13.2+ months), which included patients with stable disease, and partial and complete responses.

  • At the time of this analysis, the interim median PFS for the 54 TNBC patients was 7.0 months, with 55% of these patients having experienced a PFS event. Median overall survival data were too early to report, with 87% of patients still alive. The overall objective response rate was 31.5% (17 of 54 patients), including 2 patients with a confirmed complete response. An additional 24 patients had stable disease, resulting in a disease control rate of 76%. Treatment response was assessed by computed tomography based on the rules set by the Response Evaluation Criteria In Solid Tumors

8:33 am OncoMed Pharma reports clinical and preclinical data for Brontictuzumab and Vantictumab at the AACR-NCI-EORTC International Conference (OMED) :

Among the data presented were Phase 1a clinical trial results for brontictuzumab in patients with advanced solid tumors. Brontictuzumab demonstrated single-agent activity in a biomarker-selected refractory patient population. Among 15 patients whose tumors overexpressed the activated form of Notch1, as measured by OncoMed's proprietary immunohistochemistry (IHC) test, eight patients achieved stable disease or partial response for an overall clinical benefit rate of 53 percent. Anti-tumor activity was observed in adenoid cystic carcinoma, colorectal cancer and HER2 negative breast cancer.

  • Partial responses were observed in two patients with adenoid cystic carcinoma after just one dose of brontictuzumab. Among patients whose tumors measured high in Notch1 activation, five have survived 100 days or longer as of the data cut off. There are five additional Notch1 high patients that are currently ongoing on the study and OncoMed plans to present follow-up data on those patients when the data matures. In biomarker negative subjects, only one of 11 had clinical benefit (9%). Brontictuzumab was generally well tolerated, with the most common adverse event being on-target, manageable diarrhea. Notch pathway and cancer stem cell pathway markers were reduced in serial tumor biopsies and in surrogate patient samples (blood) at doses above 1.5 mg/kg every three weeks. The single agent Phase 2 dose of brontictuzumab was established as 1.5mg/kg every three weeks.

8:33 am European Yields (BONDX) :

Iberian Debt Underperforms

  • European sovereign debt securities are nursing last week's losses this morning, while Spanish and Portuguese notes and bonds continue to underperform. While economic growth in those two countries has been better than average this year, political instability associated with strong anti-austerity sentiment and the Catalan independence movement has kept the countries' borrowing costs higher than those of their eurozone peers
  • Portuguese sovereign debt is selling off sharply today as the country's Socialist Party agreed to join with three other leftist parties to oust the administration of the current prime minister, Pedro Passos Coelho
    • The political turmoil means that Portugal could lose its last investment grade credit rating (currently from DBRS), which would disqualify the country's debt from the ECB's EUR 1.1 tln asset purchase program (the ECB requires an investment grade rating from DBRS, Fitch, Moody's, or Standard & Poor's
    • Commerzbank sees a downgrade as a "low probability but high impact risk," according to Reuters
    • Political concerns have also hit Spanish sovereign debt in over the past four sessions, with Spain's 10-year ODE yield rising 9 basis points more than its Italian counterpart
      • The Catalonia region of Spain is making more secessionist rumblings as its parliament voted 72-63 to approve a plan to move towards independence from Spain
  • At its September meeting, the European Central Bank expanded the issue share limit for its Public Sector Purchase Program from 25% to 33%, except in cases where the Eurosystem would have a blocking minority. That change will take effect on Tuesday and, according to the ECB, will "limit undue concentration that could undermine market liquidity" and "allows for a significant increase in the purchasable amount" of securities
  • Sentix's Investor Confidence Index for the eurozone jumped to 15.1 in November from 11.7 in October
  • Germany's trade surplus unexpectedly narrowed to EUR 19.4 bln in September from EUR 19.6 bln in August
    • Export growth in Germany beat expectations, hitting 2.6% m/m in September (-5.2% in August), while imports rose a greater-than-expected 3.6% m/m (-3.2% in August)
  • Yield Check:
    • France, 10-yr OAT: -1 bp to 1.01%
    • Germany, 10-yr Bund: -2 bps to 0.68%
    • Greece, 10-yr: +1 bp to 7.62%
    • Italy, 10-yr BTP: -1 bp to 1.68%
    • Portugal, 10-yr note: +22 bps to 2.89%
    • Spain, 10-yr ODE: +4 bps to 1.96%
    • U.K., 10-yr Gilt: unch at 2.05%

8:33 am Dana Holding CFO William G. Quigley to reitre (DAN) : Quigley will continue in his current position through Nov. 30, 2015, and will remain employed with Dana in an advisory role through March 31, 2016. The Dana Board of Directors has appointed Rodney R. Filcek, Dana's current senior vice president and chief accounting officer, to serve as interim chief financial officer, in addition to his current role. His appointment is effective Dec. 1, 2015.

8:32 am Kaman to acquire GRW Bearing GmbH; expected to be accretive to EPS in 2016 (KAMN) :

Co announces that its Aerospace segment has entered into an agreement to acquire GRW Bearing GmbH, a German-based designer and manufacturer of super precision, miniature ball bearings. The company is expected to have sales in 2015 of approximately 48 mln.

  • GRW is focused on the demanding applications segment of the miniature ball bearings market, where low noise requirements, extreme temperatures, ultra-high speeds and/or caustic environments require both exceptional engineering design and continuous operating performance capabilities.
  • Co states, "On a pro-forma basis this acquisition is expected to leave us well within our target range for leverage of two to three times EBITDA. The addition of GRW is expected to be accretive to earnings per share in 2016, excluding transaction costs."
  • Terms of the transaction, which is expected to close by year end, were not disclosed.

8:32 am Pericom Semi announces that its Board has accepted the revised offer from Diodes Incorporated (DIOD) for $17.75/share in cash; termination fee increased to $15.7 mln (PSEM) : Co announced today that its Board of Directors has unanimously accepted a revised offer from Diodes Incorporated (DIOD) to acquire Pericom for $17.75 per share in cash. The revised $17.75 purchase price represents a 46% premium to Pericom's unaffected closing price and exceeds the five-year trading high in Pericom shares by 8%. Pursuant to the terms of the amendment, the termination fee has also been increased proportionately from $15 million to $15.7 million.

8:32 am BostonPrivate Fin announces that President Mark D. Thompson will retire at the end of the year (BPFH) : Thompson will stay on as CEO of the Bank and President of the Company, and continue to serve on the boards of both entities, until year-end. The Board has not yet named a successor to Mr. Thompson and is expected to take the remainder of the year to consider candidates.

8:31 am Motorcar Parts of America beats by $0.07, misses on revs (MPAA) :

  • Reports Q2 (Sep) adjusted earnings of $0.62 per share, $0.07 better than the Capital IQ Consensus of $0.55; revenues rose 29.5% year/year to $91.7 mln vs the $94.83 mln Capital IQ Consensus.
  • Gross profit as a percentage of sales for the fiscal 2016 second quarter was 23.8% compared with 26.0% a year earlier. Gross margin was impacted by product mix, as well as customer allowances related to the company's new remanufactured brake master cylinder line and additional rotating electrical business.

8:31 am Analogic appoints Mark Frost as SVP and CFO, effective November 30, 2015 (ALOG) : Co announces the appointment of Mark Frost as senior vice president, CFO and treasurer, effective November 30, 2015. He comes to ALOG from AngioDynamics (ANGO), a $365 mln medical devices company, where he served as executive vice president and CFO since 2012. Before that, he was senior vice president of administration and chief financial officer of Albany Molecular Research Incorporated, a $275 mln global contract research and drug manufacturing company.

8:31 am RealD to be acquired by Rizvi Traverse for $11 per share in cash; reports Q2 results (RLD) :

  • RLD and Rizvi Traverse Management, a private equity investor in the media, entertainment and technology sectors,  announced that they have entered into a definitive agreement pursuant to which Rizvi Traverse will acquire RealD for $11.00 per share, in an all-cash merger transaction. 
  • The transaction is valued at approximately $551 million, including net debt. Upon completion of the transaction, RealD will become a privately held company.
  • RLD separately reported Q2 (Sep) GAAP loss of $0.15 per share, $0.03 worse than the Capital IQ Consensus of ($0.12); revenues fell 18.8% year/year to $38.5 mln vs the $37.46 mln Capital IQ Consensus.

8:27 am European Markets Update: FTSE UNCH, DAX -0.2%, CAC -0.5% (:SUMRX) :

Major European indices trade lower across the board with France's CAC (-0.5%) trailing the region. Elsewhere, the Eurogroup is expected to withhold a EUR2.00 billion bailout payment for Greece due to a disagreement over foreclosure rules. On a separate note, Portuguese equities have faced some selling pressure amid expectations that a new alliance between opposition socialists and other far left parties will bring down the recently-formed center-right government. The PSI 20 is down near 3.0% in Lisbon.

  • Economic data was limited:
    • Eurozone November Sentix Investor Confidence 15.1 (expected 13.2; last 11.7)
    • Germany's September trade surplus EUR19.40 billion (expected EUR20.00 billion; previous EUR19.60 billion) as exports +2.6% (consensus 2.1%; prior -5.2%) and imports -3.6% (expected 0.9%; last -3.2%)

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  • UK's FTSE hovers near its flat line with consumer names on the defensive, InterContinental Hotels, Taylor Wimpey, and Unilever show losses between 1.3% and 3.5%. On the upside, financials outperform with Aberdeen Asset Management, Barclays, Standard Chartered, and HSBC showing gains between 1.1% and 2.6%.
  • Germany's DAX is lower by 0.2% with Continental leading the retreat. The stock has surrendered 5.2% in reaction to disappointing results. Drugmakers also lag with Bayer and Merck down 0.9% and 0.5%, respectively. On the upside, Thyssenkrupp has climbed 3.7%.
  • In France, the CAC trades down 0.5%. Renault is the weakest performer, down 2.3%, while financials BNP Paribas and Societe Generale outperform with losses of 0.2% apiece. Elsewhere, ArcelorMittal has spiked 4.1%.

8:26 am Aduro Biotech reports data from several clinical trials at the Society for Immunotherapy of Cancer Annual Meeting (ADRO) :

  • In a poster presented on Saturday, November 7, 2015 by Nitya Nair, Ph.D., scientist at Aduro, updated safety and efficacy data were shared from the Phase 2a clinical trial of Aduro's novel immunotherapy CRS-207 in combination with GVAX Pancreas in patients with metastatic pancreatic cancer. Seven patients treated with this regimen survived for over three years, with one patient continuing to receive the combination regimen.In addition, the poster highlighted key biomarker findings in 38 patients from the 93-patient trial which demonstrated a statistically significant correlation between levels of certain immune cells in the peripheral blood and overall survival.
  • In another poster presented, encouraging preclinical results demonstrated that direct intratumoral injection of Aduro's human STING-activating CDN immunotherapy in a model of HER2+ breast cancer resulted in complete eradication of the injected tumor as well as distant untreated tumors. In addition, the responses observed were durable, showing long lasting immunologic memory and anti-tumor protection when CDN-treated mice were re-challenged with HER2+ breast cancer tumor cells.
  • Separately, three additional posters were presented at the SITC meeting that provide details on the ongoing trials, namely the Phase 2b STELLAR trial in pancreatic cancer, an expanded cohort in a Phase 1b trial in mesothelioma and a Phase 1 trial in grade 3/4 gliomas, including glioblastoma multiforme.

8:26 am Nucor acquires Gerdau Long Steel's Bright Bar assets located in Orrville, Ohio, and Cartersville, Georgia, for an undisclosed amount; transaction expected to close later this month (NUE) :  

8:25 am S&P futures vs fair value: -6.70. Nasdaq futures vs fair value: -13.70. (:WRAPX) :

Equity futures continue holding modest losses with S&P 500 futures down seven points below fair value. Futures on the benchmark index have spent the past three hours ranging near their lows while European markets trade with modest losses at this juncture.

Investors did not receive any market-moving earnings reports this morning as the Q3 reporting season winds to a close. That being said, Priceline (PCLN 1367.00, -84.90) is on track to open lower by 5.8% after below-consensus guidance overshadowed better than expected results, which is likely to weigh on the consumer discretionary sector.

8:24 am On the Wires (:WIRES) :

  • Mast Therapeutics (MSTX) announced that data from a nonclinical study of vepoloxamer, its lead product candidate, will be presented at the American Heart Association's (:AHA) Scientific Sessions 2015. Compared to saline, vepoloxamer reduced LV ESV and NT-proBNP and increased LV ejection fraction without affecting LV EDV, heart rate or mean aortic pressure. These benefits were sustained for at least 2 weeks after the first infusion of vepoloxamer and up to 3 additional weeks after the second infusion of vepoloxamer. The results suggest that therapy with repeat intravenous 2-hour infusions of vepoloxamer, pulsed at 3-week intervals, elicits progressively sustained improvement in LV systolic function evident for at least 6 weeks.
  • PTC (PTC) announced the appointment of Craig Hayman to a newly created role of group president, Solutions Group, effective November 23, 2015
  • Peregrine Pharmaceuticals (PPHM) announced results from multiple new preclinical studies demonstrating enhanced anti-tumor activity and immune activation for combinations of a preclinical bavituximab equivalent and checkpoint inhibitors such as anti-PD-1 and anti-CTLA-4 in preclinical models of breast cancer and melanoma. Additionally, the company announced preliminary results for a new clinical test specifically designed to illustrate how bavituximab, the company's investigational phosphatidylserine (:PS)-signaling pathway inhibitor, modulates immune responses in the tumor microenvironment. Results from these studies were presented at the 2015 annual meeting of the Society for Immunotherapy of Cancer
  • Medtronic plc (MDT) announced the U.S. commercial availability of its VenaSeal closure system
  • EZchip Semiconductor (EZCH) issued a statement reiterating its Board's unanimous recommendation that shareholders vote FOR the Merger Proposal with Mellanox Technologies (MLNX)

8:24 am Peabody Energy reaches resolution with the New York Attorney General's office regarding its disclosures involving climate change (BTU) : Following an extensive eight-year investigation initially discussed in the company's 2007 disclosures, Peabody has agreed to amend its disclosures. There is no other action associated with this settlement, no admission or denial of wrongdoing and no financial penalty.

8:24 am CTC Media reports Q3; unable to provide guidance due to limited visibility (CTCM) :

  • Revenues were down by 15% in ruble terms and 51% in USD terms year-on-year to RUR 4.9 billion ($77.2 million), principally reflecting the estimated 13% contraction of the Russian television advertising market in the third quarter of 2015
  • OIBDA of RUR 0.6 billion ($8.3 million) with double-digit OIBDA margin of 11.6%, despite the overall TV ad market decline and the challenging macroeconomic environment.  The combined Russian national inventory was almost fully sold-out for Q3.
  • On Sept 24, 2015, in light of recent amendments to the Russian Mass Media Law further restricting non-Russian ownership of television broadcasters, the Company entered into a definitive agreement with UTV-Management, an affiliate of UTH Russia, for the sale of a 75% interest in CTC Investments, the Company's wholly owned Russian subsidiary that holds all of the Company's operating businesses for ~$200.5 million in cash, subject to adjustment. In the sale agreement, the co also agreed to authorize the issuance of an additional participation interest in CTC Investments, which would result in UTV-Management holding an 80% participation interest in CTC Investments, to ensure compliance with the foreign ownership requirements of the Mass Media Law.
  • The Company intends to convene a special meeting of stockholders in Dec 2015 to approve the sale to UTV-Management, as well as a follow-on transaction to return value in cash to stockholders.
  • In light of the continued limited visibility for 2015, the co is unable to provide full-year guidance at this time.
  • Third party reports have estimated that total Russian TV advertising spending may decline by 17-18% for the full-year.

8:18 am Multi-Color misses Q2 estimates (LABL) :

  • Multi-Color Q2 core EPS $0.93 vs $0.99 Capital IQ Consensus Estimate; revs +3% to $219.8 mln vs $228.59 mln Capital IQ Consensus
  • "Earnings per share growth is still forecasted for the second half as FX headwinds are expected to ease, less impact from price/volume declines, with stronger recent acquisition contributions and added capacity in developing markets."

8:17 am Circor beats by $0.03, misses on revs; Co closes its manufacturing facility in Brazil (CIR) :

  • Reports Q3 (Sep) earnings of $0.64 per share, excluding non-recurring items, $0.03 better than the Capital IQ Consensus of $0.61; revenues fell 21.8% year/year to $159.3 mln vs the $161.59 mln Capital IQ Consensus.
  • "Today we are announcing the decision to close our manufacturing facility in Brazil as a result of the difficult economic conditions there and the ongoing challenges of Petrobras (PBR), our largest customer," said Buckhout. "CIRCOR Brazil has reported substantial operating losses every year since it was acquired in 2011, while the underlying market conditions and outlook have continued to deteriorate."

8:11 am BioTime Q3 EPS ($0.18) vs. ($0.12) last year; rev +94% to $2.31 mln (no estimates) (BTX) :  

8:11 am Amarin comments on new data for Vascepa, in its Cherry study; patients showed a statistically significant reduction in coronary plaque volume (AMRN) :

The CHERRY study was a randomized, non-blinded, parallel group, multicenter study designed to investigate whether coronary plaque regression and stabilization are reinforced by additional administration of EPA to pitavastatin (PTV 4 mg/day) therapy in patients. Approximately 200 adult Japanese CHD patients who underwent percutaneous coronary intervention were randomly allocated to either the statin only group (n=96) or to the statin/EPA (1.8 g/day) group (n=97), prospectively followed for 6 to 8 months, and included in the primary analysis. Coronary plaque volume and composition in non-stenting lesions were analyzed by integrated backscatter-intravascular ultrasonography (IB-IVUS) at baseline and follow up. The primary endpoint was the change in coronary tissue characteristics as evaluated by IB-IVUS. Secondary end points included changes in the volume of target coronary plaques and major cardiovascular events. Baseline low-density lipoprotein cholesterol levels for the statin and statin/EPA groups were 99 and 107 mg/dL, respectively, and total cholesterol levels were 166 and 175 mg/dL, respectively. Triglyceride levels were in the normal range at baseline in both arms

  • After 6-8 months the CHERRY study showed a statistically significant reduction in coronary plaque volume (from 74.5 to 61.4 mm3; p

8:10 am Galena Biopharma prelim Q3 ($0.26) vs ($0.21) single analyst estimate; no revs (GALE) :

  • "The NASH-FX trial in 30 patients with NASH with advanced fibrosis, but not cirrhosis, is proceeding as planned."
  • "We expect that the Portland Cancer Center will begin enrolling patients in its Phase 1b study of GR-MD-02 in combination with Keytruda within the coming weeks, following the filing of its IND in October."
  • Co had $21.3 mln of non-restricted cash and cash equivalents available to fund future operations. The Company believes that its cash on hand as of September 30, 2015 is sufficient to fund currently planned operations and research and development activities through September 30, 2016. 

8:09 am Web.com will change its Nasdaq ticker symbol to 'WEB'; to become effective on the market's open on November 10, 2015 (WWWW) :  

8:08 am Denny's enters into a $50 mln accelerated share repurchase program (DENN) : The ASR agreement is part of the Company's share repurchase program authorizing the repurchase of up to $100 million of common stock as originally announced on April 1, 2015.

8:07 am Idera Pharma commences enrollment in its Phase 2 clinical trial of IMO-8400 in patients with dermatomyositis (IDRA) :  

8:07 am First Potomac Realty names Chief Operating Officer Robert Milkovich to the additional role of CEO effective immediately (FPO) : This follows Douglas J. Donatelli's decision to resign as Chief Executive Officer and a Trustee of the Company, and Nicholas R. Smith's resignation from his position as Chief Investment Officer.

8:07 am Lion Biotech enters into a two-year agreement with WuXi AppTec (WX) for additional TIL manufacturing capacity (LBIO) : The additional manufacturing capability is expected to become available within the first six months of 2016 at WuXi AppTec's facility in Philadelphia.

8:06 am Lionbridge Tech beats by $0.06, misses on revs; guides Q4 revs below consensus; announced share repurchase and acquisition; CFO to retire (LIOX) :

  • Reports Q3 (Sep) earnings of $0.14 per share, $0.06 better than the Capital IQ Consensus of $0.08; revenues rose 15.3% year/year to $138.6 mln vs the $146.45 mln Capital IQ Consensus.
  • Co issues downside guidance for Q4, sees Q4 revs of $140-143 mln vs. $148.98 mln Capital IQ Consensus Estimate.
  • Sees 2016 revenue growth of 5-8% (consensus is for +5%), and continued growth in income from operations.
  • Co also announced today that its Board of Directors has authorized a share repurchase program allowing the Company to repurchase up to $50 million of the Company's common stock through fiscal year 2018.
  • Co also announced that it has acquired New York-based Geotext Translations, a privately held provider of legal translation services. The Company expects the acquisition will contribute modestly to non-GAAP earnings in 2016, including minimal acquisition and integration costs.
  • The Company is also announcing that Donald Muir, Lionbridge's Chief Financial Officer will retire from Lionbridge. Muir will remain with the company through mid-January in support of the transition. Muir will be succeeded by Marc Litz, currently Lionbridge's Vice President, Finance and Corporate Controller, who has been with the Company for three years.

8:06 am Synergy Pharma reports Q3 results (SGYP) :

  • Q3 EPS ($0.23) vs ($0.27) Capital IQ Consensus
  • "We are continuing to focus on preparation of our first plecanatide new drug application (:NDA) for CIC and intend to file with the U.S. Food and Drug Administration (:FDA) in January 2016.
  • We anticipate top-line data from the first phase 3 IBS-C trial with plecanatide in 1H 2016. We expect top-line data from the second phase 3 IBS-C trial in 2H 2016. We intend to file our second NDA with plecanatide in the IBS-C indication by year-end 2016."

8:06 am Brainstorm Cell Therapeutics announces positive DSMB review in phase 2 trial of NurOwn in ALS (BCLI) :

Co announces that the Data and Safety Monitoring Board conducted its second pre-planned safety review of the randomized, double-blind, placebo-controlled phase 2 clinical trial of NurOwn in ALS.

  • The DSMB recommended that the study should continue as planned and identified no safety concerns.
  • Co currently expects top-line data by the end of the 2Q16

8:06 am On The Wires (:WIRES) :

  • aTyr Pharma, Inc. (LIFE) initiated Phase 1b/2 clinical trial in patients with early onset facioscapulohumeral muscular dystrophy.
  • Revolution Lighting Technologies (RVLT) secured an agreement for $1.2 mln w/ the Parsippany-Troy Hills School District, as well as a $976K contract in collaboration with Co's division, Value Lighting, to supply its G3 LED tubes for the New Rochelle Public School System.
  • 2U, Inc. (TWOU) extended its contract with the USC School of Social Work by an additional 10 years to 2030. Under the new agreement, 2U will provide USC with fixed and contingent cash payments over a 24-48 month period as well as a reduction in 2U's revenue share % to be phased in over time. 2U estimates that in aggregate, this consideration will represent a low single-digit effective reduction to 2U's current revenue share percentage over the remaining 14 years of the agreement.
  • Aspen Insurance Holdings Limited (AHL) announced the entry of its insurance segment, Aspen Insurance, into Singapore through Co's Lloyd's syndicate on Lloyd's Asia platform for January 1, 2016.

8:05 am CACI Intl receives $76.8 mln task order to provide Medical Information Delivery Systems Engineering Support to the Space and Naval Warfare Systems Center Atlantic (CACI) :  

8:05 am AstraZeneca presents a positive update on Lesinurad renal data in gout patients; demonstrated a consistent efficacy and safety profile in patients with normal renal function (AZN) :

Co announced positive subanalysis data of the Phase III lesinurad studies for the treatment of hyperuricemia associated with gout, in combination with a xanthine oxidase inhibitor (XOI).The results demonstrated a consistent efficacy and safety profile in patients with normal renal function, as well as patients with mild to moderate renal impairment.

  • Co reported that Lesinurad 200 mg in combination with an XOI resulted in consistent efficacy with a similar proportion of patients achieving sUA targets across these renal function categories. In addition, safety findings were consistent between treatment groups across all renal function categories. Renal related adverse events increased with decreasing renal function irrespective of lesinurad treatment, with no notable treatment group differences within renal function categories.
  • The incidence of serum creatinine elevations was dose dependent but did not increase with decreasing renal function.4 Renal function was stable over time in all treatment groups and across all renal function categories.

8:05 am Towers Watson issues letter to shareholders, urging them to vote for the pending merger with Willis (WSH) (TW) :  

8:04 am Kite Pharma initiates a phase 2 clinical study of KTE-C19 to treat relapsed or refractory mantle cell lymphoma (KITE) :

Co initiates a phase 2 clinical study of KTE-C19 to treat relapsed or refractory mantle cell lymphoma.

  • ZUMA-2 will proceed as a single arm, open-label, multi-center study, designed to determine the efficacy and safety of KTE-C19 in patients with MCL whose disease is refractory to or has relapsed following anthracycline- or bendamustine-containing chemotherapy and anti-CD20 monoclonal antibody therapy and ibrutinib.
  • This study plans to enroll 70 subjects.

8:04 am Valeant Pharma to provide a business update on Tuesday, November 10 at 8:00 a.m (VRX) :

J. Michael Pearson, Chairman and Chief Executive Officer, together with Robert Rosiello, Chief Financial Officer, Dr. Ari Kellen, Company Group Chairman, Deb Jorn, Company Group Chairman and Tanya Carro, Corporate Controller, will conduct the call.

  • The conference call on November 10 will consist of an overview of current plans and priorities, including the transition plan from Philidor, and an update on the Company's operations. Immediately thereafter, there will be a question and answer segment for investors and analysts.

8:04 am Altisource Residential misses by $0.32, misses on revs (RESI) :

  • Reports Q3 (Sep) loss of $0.09 per share, excluding non-recurring items, $0.32 worse than the single analyst estimate of $0.23; revenues fell 46.4% year/year to $58.52 mln vs the $81.48 mln Capital IQ Consensus.
  • The Company believes it can maintain a strong annual dividend as it transitions toward a 100% rental REIT, but more importantly afterwards as well. In the short term, the Company expects that gains on non-performing loan sales will contribute to dividends along with increasing rental income and the existing non-performing loan earnings.
  • The Company expects that it will continue to sell non-performing loans and non-rental REO properties. 
  • The liquidity provided by non-performing loan and non-rental REO sales are expected to be a growth engine that will provide Residential with buying power to increase its rental portfolio to at least 25,000 single-family rental homes in bulk and/or on a one-by-one basis.

8:04 am Investment Tech reports October 2015 US trading volumes, showing total trading volume of ~2.7 bln shares (ITG) :

Co announced that October 2015 U.S. trading volume was 2.7 billion shares and average daily volume was 122 million shares. This compares to 2.6 billion shares and ADV of 122 million shares in September 2015 and 4.7 billion shares and ADV of 206 million shares in October 2014.

  • During October 2015, overall average revenue per share increased more than 10% compared to the level in the third quarter of 2015, due in part to an increase in trading volume from buyside clients. Average daily volume during the last week in October was approximately 10% higher than the average for the full month.

8:03 am US Geothermal has entered into an agreement to acquire all of the major and long lead equipment for the construction of three binary geothermal power plants at a significant discount (HTM) : Co has entered into an agreement to acquire all of the major and long lead equipment for the construction of three binary geothermal power plants at a significant discount. The equipment was part of an order for six power plant units by another geothermal developer, but only three were installed.

8:03 am Pericom Semi: Montage issues statement noting what it believes are numerous, material incorrect premises underlying erroneous ISS recommendation (PSEM) :  

8:03 am Teva Pharma announces that the FDA has granted Breakthrough Therapy Designation status to SD-809 for the treatment of patients with moderate to severe tardive dyskinesia (TEVA) :  

8:02 am Xencor reports results from a Phase 1b/2a study of XmAb5871 in patients with rheumatoid arthritis; XmAb5871 was generally well tolerated and showed trends in improvement in RA disease activity (XNCR) :

  • The data demonstrates that XmAb5871 was generally well tolerated and showed trends in improvement in RA disease activity by multiple disease activity measures and across multiple dose groups.
  • The full data from XmAb5871 RA study demonstrates B-cell inhibition without killing B-cells, which has potential for disease modifying activity in various autoimmune diseases.
  • Expect to file an IND application this year and initiate an open-label, single-arm, multiple-dose pilot Phase 2 study in the rare autoimmune disorder IgG4-Related Disease in early 2016. 

8:02 am Dean Foods beats by $0.06, reports revs in-line; guides Q4 EPS above consensus (DF) :

  • Reports Q3 (Sep) earnings of $0.30 per share, $0.06 better than the Capital IQ Consensus of $0.24; revenues fell 14.3% year/year to $2.03 bln vs the $2.04 bln Capital IQ Consensus.
  • "Turning to the forward outlook for the fourth quarter, with the continuation of commercial and brand initiatives, diligent cost focus, seasonal demand driving beneficial product mix, and an overall favorable commodity environment which is supportive, we expect to close out this year with strong fourth quarter results."  
    • Co issues upside guidance for Q4, sees EPS of $0.28-0.38 vs. $0.24 Capital IQ Consensus Estimate.
    • Co issues upside guidance for FY15, sees EPS of $1.15-1.28 vs. $1.05 Capital IQ Consensus Estimate.

8:02 am Nuance Communications to release Q4 results on Monday, November 16, 2015, a day earlier than initially communicated (NUAN) :  

8:01 am Hemisphere Media reports Q3 (HMTV) :

  • Reports Q3 (Sep) revenues rose year/year to $31.5 mln vs the $32.2 mln Capital IQ Consensus Est
  • Net income was $2.9 mln for the three months ended September 30, 2015, an increase of $2.2 mln, as compared to net income of $0.7 mln for the same period in 2014.
  • The increase in revenue was driven by growth in advertising revenues, and higher subscriber and retransmission fees, resulting from overall growth in subscribers and rate increases
  • The increase for the nine months ended Sept 30, 2015 was also due to the inclusion of the Acquired Cable Networks, which were not included in the prior year's first quarter

8:01 am Triangle Petroleum announces redetermination of borrowing base, provides interim production update (TPLM) : Co announces that Triangle USA's lenders recently completed their October 2015 semi-annual redetermination and the borrowing base under its senior credit facility was reaffirmed at $350 mln. No terms of the credit facility were amended during this process. Preliminary production for Q3 FY 2016 averaged approximately 13,590 Boepd, which brings average production volumes fiscal year to date through October to just over 13,600 Boepd. Triangle plans to complete 2-6 gross wells in the fourth quarter of FY 2016, which should support full year production in the range of 13,200-13,600 Boepd.

8:01 am AGL Resources reports the retirement of Chairman and CEO John Somerhalder, on December 31, 2015 (GAS) : Upon Somerhalder's retirement, Andrew Evans will become president and chief executive officer. Evans, who currently is president and chief operating officer for AGL Resources, joined the company in May 2002

8:00 am Glaukos: International study shows sustained reduction in intraocular pressure through three years with two Glaukos iStent Trabecular Micro-Bypass Stents (GKOS) : Co announces that a new international study, published in the November 2015 issue of Clinical Ophthalmology, showed that two iStent Trabecular Micro-Bypass Stents provided "statistically significant, sustained and safe reduction in intraocular pressure (:IOP) to = 15 mmHg without medication through 36 months" in patients with open-angle glaucoma.

7:59 am Littelfuse confirms acquisition of TE Connectivity Ltd. (TEL) circuit protection business for $350 mln in cash; expects transaction to be immediately accretive to earnings w/ cost synergies of at least $10 mln annually starting in 2017 (LFUS) :  

7:56 am S&P futures vs fair value: -6.60. Nasdaq futures vs fair value: -15.20. (:WRAPX) :

U.S. equity futures trade near their pre-market lows amid cautious action overseas. The S&P 500 futures hover seven points below fair value after slipping from their highs prior to the start of the European session.

Similar to equity futures, Treasuries hover in the red with the 10-yr yield up one basis point at 2.34%.

Investors will not receive any economic data today.

In U.S. corporate news of note:

  • Priceline Group (PCLN 1340.00, -109.90): -7.6% after below-consensus guidance overshadowed better than expected results.
  • Apache (APA 54.23, +6.56): +13.8% after rejecting an $18.00 billion takeover offer, according to Bloomberg.
  • Weyerhaeuser (WY 29.50, -0.90): -3.0% after agreeing to merge with Plum Creek (PCL 47.00, +6.71)
  • Plug Power (PLUG 2.44, -0.32): -11.6% in reaction to below-consensus earnings on better than expected revenue.

Reviewing overnight developments:

  • Asian markets ended mostly lower. Hong Kong's Hang Seng -0.6%, China's Shanghai Composite +1.6%, and Japan's Nikkei +2.0%
    • In economic data:
      • China's October trade surplus $61.64 billion (expected $64.75 billion; prior $60.34 billion) as exports -6.9% (consensus -3.0%; prior -3.7%) and imports -18.8% (expected -16.0%; last -20.4%)
      • Japan's Average Cash Earnings +0.6% year-over-year (consensus 0.5%; prior 0.4%) and September Overtime Pay +1.4% year-over-year (last 1.5%)
      • Australia's ANZ Job Advertisements +0.4% month-over-month (last 3.8%)
    • In news:
      • China's trade surplus hit its highest level in ten years, but the fourth consecutive monthly drop in exports was a bit concerning
  • Major European indices trade lower across the board. France's CAC -0.6%, Germany's DAX -0.4%, and UK's FTSE -0.1%. Elsewhere, Italy's MIB -0.5% and Spain's IBEX -0.3%
    • Economic data was limited:
      • Eurozone November Sentix Investor Confidence 15.1 (expected 13.2; last 11.7)
      • Germany's September trade surplus EUR19.40 billion (expected EUR20.00 billion; previous EUR19.60 billion) as exports +2.6% (consensus 2.1%; prior -5.2%) and imports -3.6% (expected 0.9%; last -3.2%)
    • Among news of note:
      • The Eurogroup is expected to withhold a EUR2.00 billion bailout payment for Greece due to a disagreement over foreclosure rules.
      • Portuguese equities have faced some selling pressure amid expectations that a new alliance between opposition socialists and other far left parties will bring down the recently-formed center-right government. The PSI 20 is lower by 2.4% in Lisbon.

7:54 am TG Therapeutics reports Q3 results (TGTX) :

  • Q3 EPS ($0.28) vs ($0.38) Capital IQ Consensus Estimate; license rev flat at $38 mln.
  • Goals/Objectives for the Remainder of 2015
    • Continue to aggressively recruit into the GENUINE Phase 3 Clinical Trial of TG-1101 in combination with ibrutinib
    • Enroll the first patient by year end in our UNITY-CLL Phase 3 clinical trial of TG-1101 plus TGR-1202 in front-line and relapsed/refractory CLL
    • Announce our next registration trial evaluating 1303 in patients with NHL
    • Continue to recruit into the triple combination cohort of 1303 plus ibrutinib as well as the triple combination study of 1303 plus pembrolizumab, as well as seek to evaluate additional novel triple combinations of interest
    • Expand into autoimmune diseases with the first Phase 2 trial in Multiple Sclerosis to commence in the near-term

7:50 am Lindblad Expeditions reports Q3 results; reaffirms FY15 (LIND) :

  • Adjusted EBITDA for the third quarter was $15.8 million, a 16.2% increase from $13.6 million in the prior year quarter.
  • Lindblad generated tour revenue of $58.6 million in the third quarter of 2015, an increase of $7.1 million or 13.8% compared to the prior year quarter.
  • The Co continues to be confident it will achieve the 2015 financial projections set forth in the investor presentation filed with the SEC on April 1, 2015 which projected revenue of $204 million and Adjusted EBITDA of $45 million for the full year of 2015.
  • "We continue to see early indicators of a strong booking pace for 2016 with 63% of ticket revenue for the 2016 financial year on the books as of October 15, 2015, compared with 61% at the same time in 2014 for the 2015 financial year."

7:50 am Action Semi announces it will reschedule its Q3 earnings/conference call to before market open on Monday, November 30, 2015 (ACTS) :  

7:46 am Team Health Holdings announces an offering of $545 mln in Senior Notes due 2023 (TMH) : Co intends to use the proceeds from the offering, together with borrowings under the Company's senior secured credit facilities and cash on hand at IPC, to pay the cash consideration for the acquisition of IPC Healthcare.

7:45 am Brookfield Infrastructure announces it will make a takeover bid for all the ordinary shares of Asciano (BIP) : BidCo will offer Asciano shareholders the same consideration as the "Standard Consideration" proposed under the previously announced Scheme of Arrangement, being A$6.94 cash (reduced by the cash value of any Special Dividend paid) and 0.0387 BIP CDIs per Asciano share, which has a current implied value of A$9.21 per Asciano share.

7:42 am On the Wires (:WIRES) :

  • Monotype Imaging (TYPE) will accelerate the earnout to Swyft Media shareholders. Under the newly amended agreement, the $15 mln in additional consideration will be paid over the next three years, beginning in 4Q15. ~$5.7 mln will be paid during the 4Q15 to non-employee Swyft Media shareholders. ~$9.3 mln remaining will be paid to Swyft Media founder-shareholders in increments of ~$2 mln in January 2018 and $7.3 mln
  • Antares Pharma (ATRS) will present data from its Phase 2 study of the pharmacokinetics of subcutaneous versus oral methotrexate on November 10, 2015 at the Rheumatoid Arthritis-Small Molecules, Biologics and Gene Therapy Strategies in San Francisco. The difference in drug exposure levels creates the need for guidance on a predictive dose conversion strategy.
  • NewLink Genetics (NLNK) will present a study update from a Phase 1b/2 study of indoximod in combination with temozolomide in temozolomide-refractory glioblastoma patients will be presented at the 20th Annual Scientific Meeting and Education Day of the Society for Neuro-Oncology on November 19-22, 2015.
  • TetraLogic Pharmaceuticals (TLOG) will present two abstracts discussing clinical data on birinapant will be presented at the 57th Annual American Society of Hematology meeting to be held in Orlando from December 5-8, 2015.
  • Western Digital (WDC) and Unisplendour Corporation Limited announced an agreement to form a JV to market and sell Co's current data center storage systems in China and to develop data center storage solutions for the Chinese market in the future. The transaction has been approved by the boards of each company, and the JV is expected to become operational by the 2Q16

7:38 am Pluristem Therapeutics provides Q1 corporate and financial highlights (PSTI) :

  • As of September 30, 2015, Pluristem had $47.2 million in cash and cash equivalents, bank deposits, restricted deposits and marketable securities
  • Co's net cash used for operating activities was $3.8 million for this first quarter
  • As a result, co anticipates being well capitalized to conduct the clinical trials that are planned for initiation in 2016, as well as ongoing R&D efforts to support future products approval
  • Following successful pre-IND meeting, Pluristem agreed with the U.S. FDA on the development plan for initiation of late-stage trials of PLX-R18 in the treatment of ARS
  • The protocol is being prepared for submission. The National Institutes of Health's NIAID expressed interest in supporting and conducting the late stage trials, as they have done for earlier trials in this indication.
  • Co said, "We made significate progress in the last quarter with U.S FDA, EMA and PMDA regulatory agencies, implementing our strategy of early access to markets. We are well capitalized to continue executing our strategy and achieving multiple meaningful milestones in the coming months."

7:38 am Overnight Treasury Summary (BONDX) :

Yields Bump up to Start New Week

  • U.S. Treasury coupon securities are softer this morning after a stellar October jobs report was released on Friday. Nonfarm payrolls grew by 271K in the U.S., handily beating the Briefing.com consensus of 181K. Hourly earnings grew by 0.4% versus the Briefing.com consensus of 0.2%. San Francisco Fed President Williams, who will vote at the December FOMC meeting but not in 2016, said on Saturday that the October decision to not hike rates was "a close call." Some investors will reason that if the October FOMC decision was a close call, then Friday's strong employment data will put the nail in the coffin for a December rate hike. Today's session will see no significant U.S. economic data releases although there will be a 3-year note auction due to the Veterans Day holiday on Wednesday
  • Yield Check:
    • 2-yr: unch at 0.89%
    • 5-yr: +3 bps to 1.76%
    • 10-yr: +2 bps to 2.35%
    • 30-yr: +1 bps to 3.10%
  • International News:
    • San Francisco Fed President Williams (FOMC voter) said that the U.S. economy has hit his target for full employment based on the 5% unemployment rate
      • He said that the October decision to hold rates steady was "a close call, in part reflecting the crosscurrents we're navigating"
      • Williams said that monthly job growth of 60-100K would keep up with labor force growth
      • He said that he sees inflation reaching the Fed's 2% goal within the next two years and that the Fed "wait until we see the white's of inflation's eyes," clearly disagreeing with former Treasury Secretary Larry Summers who has suggested that the Fed do just that
    • Chinese trade figures showed a fourth-straight month of year-on-year decline in exports for October (-3.6% versus -1.1% in September) and the 12th consecutive y/y fall for imports (-16% versus -17.7% in September)
    • In Japan, average cash earnings grew 0.6% in the year to September after rising 0.4% in August
    • Germany's trade surplus unexpectedly narrowed to EUR 19.4 bln in September from EUR 19.6 bln in August
      • Export growth in Germany beat expectations, hitting 2.6% m/m in September (-5.2% in August), while imports rose a greater-than-expected 3.6% m/m (-3.2% in August)
      • The Volkswagen scandal didn't hit until September 18th, so the impact would not likely have affected the data
    • Sentix's Investor Confidence Index for the eurozone jumped to 15.1 in November from 11.7 in October
  • Fed Speaker:
    • Boston Fed President Rosengren (non-FOMC voter, will vote in 2016) (12:30 ET)
  • Treasury Auction:
    • $24 bln 3-year note auction (results at 13:00 ET)

7:37 am StoneMor Partners L.P reports Q3 results; misses on rev (STON) :

  • Adjusted EBITDA, a non-GAAP measure, was $23.5 million for Q3, an increase of over 20% YoY.
  • Rev flat at $78.2 mln vs. $80.7 mln consensus
  • Generated Distributable Available Cash, a non-GAAP measure, of $32.2 million for the 3rd quarter 2015, a 13% increase compared with the prior year 3rd quarter
  • Number of cemetery contracts written in the 3rd quarter reached 30,722, a 4% increase compared with the prior year 3rd quarter

7:34 am Iconix Brand beats by $0.12, reports revs in-line; guides FY15 EPS in-line, revs in-line; guides FY16 EPS below consensus, revs below consensus (ICON) :

  • Reports Q3 (Sep) earnings of $0.33 per share, $0.12 better than the two analyst estimate of $0.21; revenues fell 19.4% year/year to $88.9 mln vs the $89.06 mln two analyst estimate.
  • Co issues in-line guidance for FY15, sees EPS of $1.35-1.40 vs. $1.38 two analyst estimate; sees FY15 revs of $370-380 mln vs. $375.95 mln two analyst estimate.
  • Co issues downside guidance for FY16, sees EPS of $1.35-1.50 vs. $1.99 Capital IQ Consensus Estimate; sees FY16 revs of $370-390 mln vs. $412.71 mln Capital IQ Consensus Estimate.
  • "We have gone through a difficult transition period, but Iconix continues to have significant business strengths including its diversified portfolio of consumer brands, profitable business model and strong free cash flow generation. All of us at the Company are focused on capitalizing on these strengths and addressing the issues that have impacted more recent performance to improve our results and enhance value for shareholders."  

7:34 am Caladrius Biosciences reports new data for its lead product candidate CLBS20, for the treatment of metastatic melanoma (CLBS) :

Co to present data at the SITC from November 4-8 in Baltimore, Maryland.

  • The data further support the technology being explored in a currently enrolling Phase 3 clinical trial to investigate Co's lead product candidate, CLBS20, for the treatment of metastatic melanoma.
  • A new subset analysis of patient results from a 42-patient, open-label, randomized Phase 2 trial that compared the treatment effects of CLBS20 (n=18) versus a control group of irradiated tumor cells alone (n=24).
  • The analysis concluded that CLBS20 immunotherapy was associated with improved survival in each of the four different subsets defined by the stratification variables (namely measurable or non-measurable disease as defined by RECIST and most advanced stage of disease being stage IV or recurrent stage III -- see below for associated table).
  • A series of studies undertaken by the company to elucidate mechanism of action and support expectation of efficacy for CLBS20 in which the data supported the tumor-initiating properties and the antigenic potential of the self-renewing cancer-initiating cells that Caladrius isolates in its manufacturing process.
  • The data also indicate a statistically significant relationship between immune response triggered by CLBS20 and overall survival of melanoma patients.
  • The analysis showed decreases in multiple tumor and inflammation markers at four weeks after baseline in responding patients treated with CLBS20.
  • The data support Co's expectation of efficacy for CLBS20 and suggest the potential to identify the patients for whom the experimental treatment might be most effective.

7:33 am Progenics Pharm misses by $0.01, misses on revs (PGNX) :

  • Reports Q3 (Sep) loss of $0.14 per share, $0.01 worse than the Capital IQ Consensus of ($0.13); revenues fell 96.6% year/year to $1.4 mln vs the $2.35 mln Capital IQ Consensus. 
  • "We are well-positioned as we approach critical clinical milestones in the fourth quarter, including the completion of enrollment in our pivotal Phase 2b trial for Azedra and the launch of our Phase 3 program for 1404."

7:33 am Marathon Oil signs an agreement for the sale of properties in the greater Ewing Bank area and in the Gulf of Mexico for $205 million (MRO) :

Co has signed an agreement for the sale of its operated producing properties in the greater Ewing Bank area and non-operated producing interests in the Petronius and Neptune fields in the Gulf of Mexico for $205 million.

The buyer will assume all future abandonment obligations for the acquired assets. These assets represent a majority of the Company's operated and non-operated producing properties in the Gulf of Mexico.

7:33 am Fidelity & Guaranty Life to be acquired by Anbang Insurance Group for $26.80/share (FGL) : Anbang Insurance Group Co and Fidelity & Guaranty Life announce they have entered into a definitive merger agreement, pursuant to which Anbang will acquire FGL for $26.80 per share in cash.Subject to regulatory approvals and satisfaction of other customary closing conditions, the transaction is expected to close in the second quarter of 2016.

7:32 am Toll Brothers preannounces Q4 rev in-line; signed contracts +12% in untis and 29% in value (TOL) :

  • Toll Brothers sees Q4 revs $1.44 bln vs $1.43 bln Capital IQ Consensus; 1,820 units increased 6% in dollars and 1% in units FY 2015's fourth-quarter net signed contracts of $1.25 billion and 1,437 units rose 29% in dollars and 12% in units, compared to FY 2014's fourth-quarter net signed contracts of $970.8 million and 1,282 units.
  • The average price of net contracts signed in FY 2015's fourth quarter was $872,000, compared to $834,000 in FY 2015's third quarter and $757,000 in FY 2014's fourth quarter.
  • "This is the fifth consecutive quarter of year-over-year growth in contract dollars and units. Based on our strong backlog and pace of demand, we believe we will have significant growth and increased profitability in FY 2016."

7:32 am Brunswick acquires seat and table hardware maker, Garelick Mfg; terms not disclosed (BC) : Garelick had annual sales of ~$21 million in 2014.

7:32 am Immune Pharma announces FDA acceptance of its IND application for Bertilimumab, to treat Bullous Pemphigoid; enables expanded recruitment for its clinical trials (IMNP) :  

7:31 am Newstar Financial announces a $50 mln offering of its senior notes due 2020 (NEWS) : Co intends to use the proceeds of this offering, after the payment of fees and expenses, for general corporate purposes.

7:31 am Paratek Pharma initiates Omadacycline Phase 3 Clinical Study in community acquired bacterial Pneumonia, top-line data from this pivotal study is projected to be available in the second half of 2017 (PRTK) :  

7:31 am ArQule reports the preclinical and clinical studies focusing on Rivantinib at the AACR-NCI-EORTC Conference (ARQL) :

Co announced the results of preclinical and clinical studies focusing on tivantinib, ARQ 087, ARQ 092, and ARQ 751. For the first time, data from an exploratory sub-analysis of the MARQUEE trial with tivantinib in non-small cell lung cancer in patients with advanced disease and epidermal growth factor receptor mutations were presented.

  • The data showed tivantinib, when added to erlotinib, increased progression-free survival to 13 months compared to 7.5 months in the erlotinib plus placebo arm. Additionally, the company presented pre-clinical and clinical data on its early stage proprietary pipeline that support ArQule's efforts to address the needs of patients in therapeutic areas of high unmet need through precision medicine.
  • Data presented on FGFR inhibitor, ARQ 087, demonstrate that FGFR2 dysregulation correlates with efficacy and supports the on-going phase 2 trial in intrahepatic cholangiocarcinoma. Similarly, data presented on AKT inhibitors, ARQ 092 and ARQ 751, demonstrate that both drugs inhibit AKT and provide strong rationale for further studies in patients harboring AKT1 and PI3K mutations.

7:31 am Marsh McLennan's Marsh acquires GAMA Consultores Associados; terms not disclosed (MMC) : Co acquires GAMA Consultores Associados, retirement consulting firm in Brazil.The transaction is expected to close in 4Q15.

7:30 am Rogers Corp appoints Janice Stipp as CFO; replaces David Mathieson, who recently announced his retirement (ROG) : Stipp most recently served as Executive Vice President, CFO and Treasurer at Tecumseh Products Company (TECU)

7:28 am Affiliated Managers beats by $0.06, misses on revs (AMG) :

  • Reports Q3 (Sep) economic earnings of $2.93 per share, excluding non-recurring items, $0.06 better than the Capital IQ Consensus of $2.87; revenues fell 4.2% year/year to $613.1 mln vs the $634.31 mln Capital IQ Consensus.
  • Economic earnings per share of $2.93 increased over the year-ago period as compared to a year-over-year decline in the global indices, and its results for the quarter demonstrate the strength of its business in the face of challenging market conditions.

7:27 am Priceline beats by $1.11, beats on revs; guides Q4 below consensus (PCLN) :

  • Reports Q3 (Sep) earnings of $25.35 per share, $1.11 better than the Capital IQ Consensus of $24.24; revenues rose 9.4% year/year to $3.1 bln vs the $3.06 bln Capital IQ Consensus.
    • Gross travel bookings for The Priceline Group, which refers to the total dollar value, generally inclusive of all taxes and fees, of all travel services purchased by its customers, were $14.8 billion, an increase of 7% over a year ago (~22% on a constant currency basis).
  • Co issues downside guidance for Q4, sees EPS of $11.10-11.90, excluding non-recurring items, vs. $12.39 Capital IQ Consensus; sees Q4 revs +1-8% to ~$1.86-1.99 bln vs. $2.05 bln Capital IQ Consensus Estimate. 
    • Year-over-year increase in total gross travel bookings of ~1% - 8% (an increase of ~13% - 20% on a constant currency basis).
    • Year-over-year increase in international gross travel bookings of ~3% - 10% (an increase of ~17% - 24% on a constant currency basis).
    • U.S. gross travel bookings are expected to decrease by 5% - 10% as compared to 4th quarter 2014. 
    • Peer: EXPE.

7:25 am Monotype Imaging accelerates earnout in Swyft Media acquisition; reaffirms Q4 guidance (TYPE) :

  • Co reaffirms guidance for Q4 (Dec), sees EPS of $0.29-0.33 vs. $0.30 Capital IQ Consensus Estimate; sees Q4 (Dec) revs of $48.0-50.5 mln vs. $49.65 mln Capital IQ Consensus Estimate; co sees adjusted EBITDA of $19.5-22.0 mln,
  • Co announces that in association with its Jan. 30, 2015 acquisition of Swyft Media, Monotype is accelerating the payment of earnout amounts to Swyft Media shareholders. At the time of the acquisition, the transaction included an opportunity for Swyft Media shareholders to realize up to $15 mln in additional consideration based on attainment of certain performance criteria through 2017.

7:24 am Harsco beats by $0.18, misses on revs; guides Q4 EPS below two analyst estimate; will pursue strategic options for separation of its metals & minerals business; slashes quarterly dividend (HSC) :

  • Reports Q3 (Sep) earnings of $0.18 per share, $0.18 better than the two analyst estimate of $0.10; revenues fell 18.6% year/year to $428.33 mln vs the $454.1 mln two analyst estimate.
  • Co issues downside guidance for Q4, sees EPS of 0.00-0.05 vs. $0.12 two analyst estimate.
  • The co separately announced it will pursue strategic options for the separation of the Company's Metals & Minerals segment
  • The Board approved a quarterly dividend of $0.051 per share beginning with the first quarter 2016 dividend payment on February 16, 2016 to shareholders of record as of the close of business on January 15, 2016. The dividend adjustment was made in light of present industry macroeconomic factors with a goal to preserve capital for operations and strategic initiatives, and maintain a healthy capital structure, while at the same time enabling Harsco to continue its longstanding practice of returning capital to shareholders. The Company's fourth quarter dividend of $0.205 per share will be paid on November 16, 2015 to shareholders of record as of the close of business on October 15, 2015, as previously announced.

7:22 am Vanguard Natural Resources reports EPS in-line (VNR) :

  • Reports Q3 (Sep) earnings of $0.02 per share, excluding non-recurring items, in-line with the Capital IQ Consensus of $0.02.
  • Oil, natural gas and natural gas liquids sales fell 41% YoY to $90.8 mln.
  • Co closed the LRR Energy LP ("LRE") and Eagle Rock Energy Partners, LP ("EROC") mergers in the first week of October. It goes without saying that consummating two mergers at the same time posed a challenge for the company
  • Adjusted EBITDA decreased 19% to $88.2 mln in Q3 of 2015 from $108.2 mln in Q3 of 2014 and decreased 3% from the $90.6 mln recorded in Q2 of 2015.
  • Co currently anticipates a total capital expenditures budget for the remainder of 2015 to range between $31.0-34.0 mln, excluding any potential future acquisitions

Hedges:

  • Co has implemented a hedging program for ~79% and 50% of its anticipated crude oil production in 2015 and 2016, respectively, with 84% in the form of fixed-price swaps for the balance of 2015; ~88% and 68% of its natural gas production in 2015 and 2016, respectively, is hedged with 100% in the form of fixed-price swaps for the balance of 2015. NGLs production is hedged using fixed-price swaps for ~9% and 21% of anticipated production for the balance of 2015 and 2016, respectively.

7:21 am Warren Resources misses by $0.03, misses on revs; narrows FY15 production (WRES) :

  • Reports Q3 (Sep) loss of $0.23 per share, excluding non-recurring items, $0.03 worse than the two analyst estimate of ($0.20); revenues fell 48.6% year/year to $20.8 mln vs the $23.94 mln two analyst estimate. 
  • Warren expects to continue experiencing strong total production, primarily due to continued outperformance of gas production from the Marcellus as compared to the company's internal type curves. In addition, with a relatively moderate projected base production decline rate in its waterflood properties in California's Wilmington field and a strong inventory of locations in that field, we believe Warren is well positioned to return to oil production growth in the event that the reserves become economic.
  • Strong gas production of 7.3 billion cubic feet (Bcf) hits upper end of guidance
  • Consistent oil production of 243 thousand barrels (MBbls) at midpoint of guidance

7:20 am Impax Labs beats by $0.01, beats on revs (IPXL) :

  • Reports Q3 (Sep) earnings of $0.40 per share, excluding non-recurring items, $0.01 better than the Capital IQ Consensus of $0.39; revenues rose 39.9% year/year to $221.1 mln vs the $214.1 mln Capital IQ Consensus.

7:18 am Installed Building Products acquires Sierra Insulation Contractors, Inc. and Eco-Tect Insulation, Inc. (IBP) : Both Sierra and Eco-Tect are installers of fiberglass and cellulose insulation.

7:17 am TiVo reports that it has surpassed 4 mln international subscriptions through its traditional TiVo offering (TIVO) :  

7:17 am Curis reports Q3 results (CRIS) :

  • Reports Q3 (Sep) loss of $0.04 per share, $0.04 better than the Capital IQ Consensus of ($0.08); revenues rose 13.6% year/year to $2 mln vs the $2.81 mln Capital IQ Consensus.
  • "Aurigene scientists presented compelling preclinical data for each program this weekend at the AACR-NCI-EORTC International Conference, and our internal team is working diligently with Aurigene to advance both programs into clinical development. During the first half of 2016, we expect to file an IND and initiate Phase 1 clinical testing of the PD-L1/VISTA inhibitor, CA-170, and also expect to file an IND for development of the IRAK4 inhibitor."
  • "We have also been working to advance CUDC-907 into the next stage of clinical development. We expect to provide additional data from the ongoing Phase 1 trial, as well as details of the planned Phase 2 study at the ASH annual meeting later this year."

7:15 am BioDelivery Sciences misses by $0.07, misses on revs (BDSI) :

  • Reports Q3 (Sep) loss of $0.39 per share, $0.07 worse than the Capital IQ Consensus of ($0.32); revenues fell 33.3% year/year to $1.2 mln vs the $1.6 mln Capital IQ Consensus. 
  • Nearly 18,000 prescriptions dispensed for BUNAVAIL during the third quarter 2015, representing a 26% increase over second quarter. BUNAVAIL prescriber base expanded to nearly 2,300 physicians, with 463 new prescribers added during the third quarter. "With the BUNAVAIL launch gaining strong momentum, the downstream benefits of the recent FDA approval of BELBUCA, the continued development of our pipeline, and a solid cash position that is expected to support our current operating plan to mid-2017, we believe that BDSI is well-positioned for future growth."
  • Launch of BELBUCA by partner Endo Pharma (ENDP) anticipated in the first quarter of 2016

7:15 am National Bank announces termination of its FDIC loss share agreements (NBHC) :

Co entered into an early termination agreement with the Federal Deposit Insurance Corporation that terminates the Bank's loss share agreements with the FDIC, and made a payment of $15.1 million to the FDIC as consideration for the early termination of the loss share agreements.

  • There will be an immediate positive impact to ongoing earnings through the elimination of amortization expense associated with the FDIC indemnification asset, which totaled $20.8 million, or $0.42 per share, through the first nine months of 2015. In the fourth quarter of 2015, the Bank expects to record a one-time after-tax gain of approximately $2.6 million, or $0.09 per share, resulting primarily from the settlement payment made to the FDIC and the write-off of the remaining FDIC indemnification asset of $18.2 million and the clawback payable of $38.7 million as of September 30, 2015.

7:14 am Northstar Realty reports Q3 (Sep) results, beats on revs (NRF) :

  • Reports Q3 (Sep) loss of $0.69 per share, may not be comparable to the two analyst estimate of $0.10; revenues rose 171.8% year/year to $528.2 mln vs the $477.19 mln Capital IQ Consensus.

7:12 am Mirna Therapeutics presents interim results from its ongoing Phase 1 clinical trial of MRX34 which show that MRX34 has a safety profile manageable with standard interventions or tests used by oncologists, and demonstrate the therapeutic potential of miR-34 replacement therapy (MIRN) :

Interim safety, efficacy and biomarker data from the multicenter, open-label Phase 1 clinical trial in solid tumor patients show that MRX34 has a safety profile manageable with standard interventions or tests used by oncologists, and demonstrate the therapeutic potential of miR-34 replacement therapy. Additionally, dose-dependent effects on miR-34 target genes in patients' white blood cells have been observed. As of August 13, 2015, two patients with advanced, metastatic Stage IV cancer have achieved clinical responses after treatment with MRX34: one patient with primary liver cancer (hepatocellular carcinoma, HCC) metastatic to the lung, and one patient with acral melanoma, metastatic to lymph nodes, showed more than 30 percent tumor shrinkage (confirmed partial responses). 

  • Enrollment in the expansion phase is expected to be complete by the end of 2016.

7:11 am NorthStar Asset Mgmt reports Q3 results (NSAM) :

  • Q3 GAAP EPS $0.21 vs $0.17 single analyst estimate; revs $108.1 mln vs $111.38 mln single analyst estimate.
  • Cash available for distribution of $0.26 per share. NorthStar Realty completed the spin-off of its European real estate business into a separate publicly-traded REIT, NorthStar Realty Europe (NRE).
  • Total assets of managed companies as of September 30, 2015 of ~$37.9 billion, including investments under contract or acquired by our managed cos subsequent to the third quarter 2015 and including the announced Townsend acquisition.

7:11 am Plug Power misses by $0.01, beats on revs (PLUG) :

  • Reports Q3 (Sep) loss of $0.06 per share, $0.01 worse than the Capital IQ Consensus of ($0.05); revenues rose 57.8% year/year to $31.4 mln vs the $30.7 mln Capital IQ Consensus.
  • Notes that in the fourth quarter, co is on track for a third straight quarter of record revenues.

7:09 am Perrigo responds to 'misleading statements regarding Marc Coucke and again issues a letter to shareholder recommending they do not tend their shares to Mylan's (MYL) offer (PRGO) : In response, Mr. Coucke comments, "I believe that Mylan's Executive Chairman made comments about me recently. Let me be clear. First, I do not appreciate anyone speaking on my behalf, especially when it is misleading and inaccurate. Second, I support the unanimous decision of Perrigo's Board of Directors in strongly recommending that Perrigo shareholders NOT tender their shares into Mylan's offer."

7:09 am UCP beats by $0.22, beats on revs (UCP) :

  • Reports Q3 (Sep) earnings of $0.20 per share, $0.22 better than the single analyst estimate of ($0.02); revenues rose 32.1% year/year to $73.7 mln vs the $68.02 mln two analyst estimate.
  • Backlog on a dollar basis expanded to $121 mln, compared to $38.9 mln.

7:08 am Alnylam Pharma misses by $0.01, misses on revs; hosting R&D Day December 10 (ALNY) :

  • Reports Q3 (Sep) loss of $0.91 per share, excluding non-recurring items, $0.01 worse than the Capital IQ Consensus of ($0.90); revenues fell 42.7% year/year to $6.3 mln vs the $6.45 mln Capital IQ Consensus. 
  • Alnylam plans to host an R&D Day on Thursday, December 10, 2015.
  • In addition, during late 2015, Alnylam plans to:
    • Present updated data from ongoing Phase 1 clinical trial of ALN-PCSsc at the American Heart Association (:AHA) Scientific Sessions 2015, being held November 7 -- 11, 2015, in Orlando, Florida, in late-breaking oral presentation on Wednesday, November 11, at 10:45 am ET.
    • Present multi-dose data from ongoing Phase 1 clinical trial of ALN-CC5 at the 57th American Society of Hematology (ASH) Annual Meeting and Exposition being held December 5 -- 8, 2015 in Orlando, in a poster presentation on Sunday, Dec 6 at 6:00 pm ET. This will include the first-ever report on results with weekly dose administration of ALN-CC5, as all previously reported data -- including those in the now-published ASH abstract -- pertain to single doses of study drug.
    • Present monthly dosing data from ongoing Phase 1 clinical trial of ALN-AT3 in an oral presentation at ASH, on Monday, Dec 7 at 11:30 am ET.
    • Initiate Part C of ongoing Phase 1 trial of ALN-CC5 in patients with paroxysmal nocturnal hemoglobinuria (:PNH).
    • Initiate Phase 2 clinical trial with ALN-PCSsc, in collaboration with The Medicines Company (MDCO), in late 2015.

7:07 am Horizon Pharma guides for FY16 revenues ahead of consensus, reviews 2020 long-range plan which projects potential for $2 bln in annual sales (HZNP) :

Ahead of today's investor meeting, Horizon provided FY16 sales and EBITDA guidance, as well as outlined its long-range plan.

  • The company provided first-time full-year 2016 net sales guidance of $950 to $975 million vs. the $900.79 mln Capital IQ consensus estimate , which would represent more than 25 percent year-over-year growth at the midpoints of Horizon's 2015 and 2016 guidance ranges.
  • Providing first-time full-year 2016 adjusted EBITDA guidance of $460 to $475 million, which would represent more than 30 percent year-over-year growth at the midpoints of Horizon's 2015 and 2016 guidance ranges.
  • 2020 full-year net sales potential in long-range plan of more than $2 billion, which includes sales from ACTIMMUNE in Friedreich's ataxia, assuming approval for that indication. 
  • If ACTIMMUNE is approved in selected cancer indications, based on the Company's long-range plan, it could present an additional net sales potential of $300 to $500 million in 2020.

7:07 am Ply Gem Holdings beats by $0.03, misses on revs; guides EBITDA (PGEM) :

  • Reports Q3 (Sep) earnings of $0.60 per share, $0.03 better than the Capital IQ Consensus of $0.57; revenues rose 21.3% year/year to $530.9 mln vs the $553.19 mln Capital IQ Consensus.
  • "As the housing market in the U.S. continues to recover, we expect to generate meaningful operating leverage and earnings in our long-term outlook."
    • Expects fourth quarter adjusted EBITDA to be in the range of $32 to $37 million which would provide a full year 2015 adjusted EBITDA of $173 to $178 million.

7:07 am Sunesis Pharma reports preclinical data from its BTK and PDK1 inhibitor programs at the AACR-NCI-EORTC International Conference (SNSS) :

Co stated:

  • "Each shows compelling, anti-cancer activity and a distinct product profile. SNS-062, our novel, second-generation BTK inhibitor, maintains potent preclinical activity in the presence of a cysteine-481 mutation associated with acquired resistance to ibrutinib. In addition, SNS-062 has a kinase selectivity profile distinct from ibrutinib that may confer additional safety and efficacy advantages that we look forward to uncovering in our upcoming clinical studies.
  • SNS-510 and SNS-229, which belong to a novel class of PDK1 kinase inhibitors, show broad activity in a variety of hematologic cancer cell lines, including cell lines resistant to PI3K and AKT inhibitors, that correlates with significant PDK1 pathway modulation and anti-proliferative activity. We believe this program could soon yield a first-in-clinic selective PDK1 inhibitor to test this important pathway in cancer patients.
  • Near term, we look forward to advancing SNS-062 into the clinic in the first quarter of 2016."

7:05 am Galena Biopharma reports data from its GALE-301 and GALE-302 clinical programs; preliminary analysis revealed both agents are immunogenic and well tolerated (GALE) :

Co announces data from the GALE-301 and GALE-302 clinical programs were presented at the SITC Meeting in National Harbor.

  • This preliminary analysis revealed both agents are immunogenic and well tolerated with no differences in toxicities between PVS sequences.
  • The study demonstrates that the in vivo immune response is enhanced with the use of the attenuated E39' (GALE-302) after E39 (GALE-301).
  • The optimal vaccination sequence utilizing three inoculations of GALE-301 followed by three inoculations of GALE-302 produced the most prominent and statistically significant LR and DTH responses.
  • Co achieved a statistically significant increase in LR and DTH when delivering E39 followed by E39' in the PVS.

7:05 am Compugen presents results from a translational study supporting the potential treatment of rheumatoid arthritis w/ CGEN-15001 (CGEN) :

The translational study was designed to evaluate the potential to translate the efficacy of CGEN-15001, previously observed in animal models of the disease, to human patients.

  • In the reported results, CGEN-15001 was shown to inhibit the secretion of various RA-related inflammatory cytokines in these co-cultures, including for example TNFa, IFN? and GM-CSF, pointing to the mechanism by which this drug can potentially treat RA. The anti-inflammatory effect was observed initially in healthy donors' cells and was then successfully reproduced in cells from RA patients, thereby confirming that the CGEN-15001 pathway is functional and responsive in these autoimmune patients.

7:05 am TravelCenters of America misses by $0.05, misses on revs (TA) :

  • Reports Q3 (Sep) earnings of $0.26 per share, $0.05 worse than the Capital IQ Consensus of $0.31; revenues fell 24.9% year/year to $1.51 bln vs the $1.72 bln Capital IQ Consensus.
  • Fuel sales volume for the 2015 third quarter increased by 36.7 million gallons, or 7.1%, compared to the 2014 third quarter due to sites acquired since the beginning of the 2014 third quarter and increased same site fuel sales volume.
  • Fuel revenue for the 2015 third quarter declined by $544.6 million, or 34.6%, primarily due to the significantly lower market prices for fuel in the 2015 third quarter than in the 2014 third quarter.

7:04 am Sotheby's beats by $0.02, beats on revs (BID) :

  • Reports Q3 (Sep) loss of $0.26 per share, excluding non-recurring items, $0.02 better than the Capital IQ Consensus of ($0.28); revenues rose 46.5% year/year to $138 mln vs the $111.06 mln Capital IQ Consensus. 
  • "In just three days last week, our auctions achieved $780 million, led by the first two sales from the collection of Sotheby's former Chairman, Alfred Taubman."

7:04 am Johnson & Johnson's Janssen signs exclusive license agreement with Hanmi Pharmaceutical (JNJ) :

Hanmi Pharmaceuticals announced that it has entered into an exclusive license, agreement with Janssen Pharmaceuticals, Inc., for the development and commercialization of oxyntomodulin-based therapies including Hanmi's HM12525A (LAPSGLP/GCG), a novel biologic GLP-1/Glucagon dual receptor agonist to treat diabetes and obesity, which is expected to enter Phase 2 studies next year.

  • Under the terms of the agreement, Janssen will obtain exclusive worldwide rights, except Korea and China, to develop and commercialize HM12525A. Hanmi will receive an upfront payment of $105 million, and is eligible for up to $810 million in potential clinical development, regulatory and sales milestones. If HM12525A is successfully commercialized, Hanmi would also be eligible for tiered double-digit royalty payments. The agreement is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions.

7:04 am Immunomedics reports new preclinical data for sacituzumab govitecan, demonstrating synergy with olaparib (IMMU) :

Co reported that new preclinical data for sacituzumab govitecan, the Company's lead antibody-drug conjugate for solid cancer therapy, demonstrated synergy with olaparib, a poly(adenosine diphosphoribose) polymerase inhibitor, as well as microtubule inhibitors, such as paclitaxel or eribulin mesylate, in various animal models of human triple-negative breast cancer.

  • Sacituzumab govitecan combined with paclitaxel was evaluated in a mouse model of human TNBC. Tumor-bearing mice treated with the combination significantly inhibited tumor growth, resulting in a doubling of median survival when compared to all other treatments. Sacituzumab govitecan plus eribulin mesylate also produced significant survival benefit over other treatment groups.

7:03 am ISIS Pharm beats by $0.03, misses on revs (ISIS) :

  • Reports Q3 (Sep) loss of $0.30 per share, $0.03 better than the Capital IQ Consensus of ($0.33); revenues rose 11.3% year/year to $49.1 mln vs the $52.54 mln Capital IQ Consensus. 
  • "Yesterday, we reported positive clinical data on our APO(a) LICA program, showing that our LICA technology can create drugs that are 30-fold more potent in humans than our generation 2.0+ antisense drugs. The increase in potency of our LICA drugs could translate into a small and convenient dose that patients could administer weekly, monthly, quarterly or even less frequently. This, obviously, has implications for uptake, adherence and compliance and opens up broader patient populations for all of our LICA drugs."

7:03 am POZEN misses by $0.23, beats on revs (POZN) :

  • Reports Q3 (Sep) loss of $0.25 per share, $0.23 worse than the two analyst estimate of ($0.02); revenues fell 22.7% year/year to $5.8 mln vs the $5.25 mln two analyst estimate.
  • Remains on track to close the transaction with Tribute Pharmaceuticals in December of this year

7:03 am Cyclacel Pharma presents preclinical data demonstrating the mechanistic rationale for the development of CYC065 in targeted solid tumors and leukemias (CYCC) :

Co presents preclinical data demonstrating the mechanistic rationale for the development of CYC065 in targeted solid tumors and leukemias.

  • Data presented at AACR-NCI-EORTC demonstrated the mechanistic rationale for clinical development of CYC065 in oncology.
  • Relevant solid tumor and hematologic malignancies were identified, including those with amplification or overexpression of Cyclin E (the partner of CDK2), those driven by CDK9-dependent oncogenic and leukemogenic pathways, such as acute leukemias driven by MLLr and MYC overexpressing tumors. Clinically relevant synergistic combinations were identified and the mechanism of action of CYC065 as a single agent elucidated.
  • The anticancer activity of CYC065 was evaluated in in vitro assays of human acute myelogenous leukemia and triple negative breast cancer cell lines to demonstrate the pro-apoptotic mechanism of CYC065 and determinants of cellular sensitivity.
  • CYC065 induced rapid apoptosis by inhibition of expression of CDK9-dependent oncogenic transcripts, including MCL-1 and MYC. CYC065's potent anticancer activity was confirmed in AML xenograft animal models.
  • CYC065 was highly synergistic in combination with Bcl-2 inhibitors, such as venetoclax (ABT-199/GDC-0199), in both AML and acute lymphoblastic leukemias. CYC065 was also synergistic in combination with Co's sapacitabine in breast cancer cell lines, as was the case with seliciclib, Co's first generation CDK2/9 inhibitor.
  • An oral regimen of seliciclib and sapacitabine is being evaluated in an on-going Phase 1 study of patients with Homologous Recombination (HR) repair-deficient breast, ovarian and pancreatic cancers, including BRCA positive tumors.

7:03 am Antares Pharma to present data derived from its Phase 2 study of the pharmacokinetics of subcutaneous versus oral methotrexate in the treatment of rheumatoid arthritis (ATRS) : In a Phase 2, 12-week open label, crossover study, 49 adults with rheumatoid arthritis already receiving oral methotrexate for more than three months were given 10, 15, 20 or 25 mg of OTREXUP based on their current MTX dose and disease control. The patients were randomized as to dose order. After dosing, blood samples for pharmacokinetic analysis were collected, analysed and dose-normalized parameter ratios were calculated. Using regression analysis methods, researchers identified a dose-conversion strategy that could provide guidance to rheumatologists seeking to convert oral methotrexate patients to OTREXUP.

7:02 am Anavex presents positive safety and cognitive efficacy data for ANAVEX 2-73; study met the primary objective of safety (AVXL) :

Co presented positive safety and cognitive efficacy data for ANAVEX 2-73, the Company's lead investigational oral treatment for Alzheimer's disease targeting sigma-1 and muscarinic receptors.

  • Initial analysis of Phase 2a data demonstrated that the study met the primary objective of safety as ANAVEX 2-73 was well tolerated and results were consistent with prior Phase 1 clinical trial data. The secondary objectives were also met, with ANAVEX 2-73 showing cognitive improvement across all doses in all exploratory cognitive measurements, including the Cogstate battery, Mini Mental State Examination (:MMSE), event-related potentials (:ERP) and P300 tests, which consistently demonstrated improvements from baseline in the completed PART A portion of the study in 32 mild-to-moderate Alzheimer's patients.
  • Even though PART A was designed as a 5 week bioavailability trial that included a built-in wash-out period of 12 days and without an optimized dosing regimen, several Cogstate tests demonstrated highly statistically significant improvements. This finding was supported by a trend towards improvement in median MMSE score, which increased by +1.5 over baseline at week 5.
  • In the interim analysis of the first 14 patients at week 12, the PART B portion of the study demonstrated a positive trend towards improvement over 12 weeks of ANAVEX 2-73 treatment on the secondary functional outcome measure, the Alzheimer's Disease Co-operative Study - Activities of Daily Living Inventory (ADCS-ADL) by +3.21 points.

7:02 am Community Health announces a new 10 mln share repurchase program (CYH) :  

7:01 am FEI reports the receipt of a significant order for two Titan Krios transmission electron microscopes (FEIC) : Co announced the receipt of a significant order for two Titan Krios cryotransmission electron microscopes (cryo-TEMs) from the University of Leeds,based in the United Kingdom.

7:01 am Hospitality Props beats by $0.04 (HPT) :

  • Reports Q3 (Sep) funds from operations of $0.99 per share, $0.04 better than the Capital IQ Consensus of $0.95.
  • "We are pleased with the continued strong performance from our hotel and travel center portfolios this quarter which resulted in Normalized FFO per share growth of 15.1% and Adjusted EBITDA growth of 13.0%. Our comparable hotel RevPAR growth of 7.8% exceeded the hotel industry's performance for the eleventh consecutive quarter. We were also active on the acquisition front this quarter, expanding both our travel center and hotel portfolios at prices we believe are attractive."

7:01 am AlereAlere SD BIOLINE HIV/Syphilis Duo test has been awarded World Health Organization prequalification (ALR) :  

6:58 am Novavax misses by $0.03, misses on revs (NVAX) :

  • Reports Q3 (Sep) loss of $0.12 per share, $0.03 worse than the Capital IQ Consensus of ($0.09); revenues fell 20.7% year/year to $6.5 mln vs the $10.1 mln Capital IQ Consensus. This revenue decrease results from a lower level of development activities under the HHS BARDA contract in the third quarter of 2015 as compared to the same period in 2014.
  • Co also announced initiation of a Phase 3 trial of the RSV F Vaccine in older adults
  • Expects initiation of a Phase 3 trial of the RSV F Vaccine to protect infants via maternal immunization, contingent upon discussions with regulatory authorities, in the near-term.

6:58 am On The Wires (:WIRES) :

  • Foundation Medicine (FMI) will present on the application of FoundationOne Heme to identify druggable genomic alterations, inform personalized treatment strategies and improve clinical outcomes at the 2015 ASH Meeting in Orlando.
  • LTE chipmaker Sequans Communications (SQNS) and Tricheer Technology announce a partnership, whereby Tricheer has adopted Co's LTE-Advanced chipsets to build mobile devices for several markets in Europe and Asia.
  • Wabtec (WAB) signs a $27 mln contract w/ Regional Rail Partners to provide Phase I signaling and communications systems for the new North Metro Rail Line in Denver.
  • LSI Industries (LYTS) has been chosen by Kroger (KR) to replace traditional HID technology in ~1000 fuel centers across the U.S w/ Co's LED fixtures.

6:58 am Fuel Systems Solutions sees Q3 rev just below estimates; files to delay Q3 10-Q, determining whether asset impairment is needed related to pending merger with Westport (WPRT) (FSYS) :

  • Co expects to delay the announcement of its third quarter financial results and that it expects to file a notification of late filing (Form 12b-25) for its Quarterly Report on Form 10-Q for Q3.
  • In connection with the Company's pending merger with Westport Innovations (WPRT), an analysis must be performed to determine whether the Company may be required to record an asset impairment charge. Therefore, the Company is cancelling its conference call scheduled for November 9th and does not expect to conduct a third quarter 2015 conference call. The Company will issue an earnings release and file its Form 10-Q for Q3 once the impairment analysis is completed.
  • To provide information in the interim, Fuel Systems preliminarily announces that it expects third quarter 2015 revenue of ~$65.5 mln vs. $66.4 mln consensus and gross profit margin of ~ 23%.

6:55 am Scripps Networks Interactive beats by $0.07, beats on revs; guides FY15 revs above consensus (SNI) :

  • Reports Q3 (Sep) earnings of $1.06 per share, excluding non-recurring items, $0.07 better than the Capital IQ Consensus of $0.99; revenues rose 20.4% year/year to $776.1 mln vs the $761.09 mln Capital IQ Consensus.
  • Now expects full-year revenue to increase approximately 13%, which would equate to 3.01 bln vs. $2.99 bln Capital IQ Consensus Estimate.

6:52 am Arch Coal beats by $2.15, misses on revs; high stock piles to dampen thermal coal demand and pricing throughout 2016 (ACI) :

  • Reports Q3 (Sep) loss of $3.38 per share, excluding non-recurring items, $2.15 better than the Capital IQ Consensus of ($5.53); revenues fell 7.2% year/year to $688.5 mln vs the $697.77 mln Capital IQ Consensus; adj. EBITDA +87% $135 mln.
  • Arch has elected to terminate its $250 million revolver which will become effective on Nov 11, 2015. The co had no borrowings under its revolver and no intention to borrow under it. On a pro-forma basis, taking into consideration the termination of the revolver, Arch had liquidity of $704.4 million at September 30, 2015 with $694.5 million of that in cash and liquid securities.
  • Arch now expects domestic thermal coal consumption to decline by 95 million tons during 2015. While supply cuts are well underway and will reduce U.S. thermal coal production markedly during the year, Arch nevertheless expects stockpiles at U.S. power generators to climb to more than 185 million tons, or over 90 days of supply, at year-end. These inflated levels are expected to dampen thermal coal demand and pricing throughout next year.
  • Conditions in U.S. metallurgical coal markets remain challenging as well due to deteriorating global steel demand, continued strong output from Australia and a strong U.S. dollar that hinders U.S. competitiveness.
  • "We believe that announced production cuts and the continued lack of investment in new metallurgical production simply will not be enough to balance the market, and that additional reductions will be necessary across our industry," Lang said. "As a result, we expect pricing for both metallurgical and thermal coal to remain under significant pressure throughout 2016."

6:52 am Volaris Aviation launches a follow-on equity offering from selling stockholders, for 90 mln ADRs (VLRS) : Collectively, the selling shareholders are selling approximately 25% of their overall equity interest in the Company

6:52 am Atento beats by $0.03, beats on revs; reiterates rev guidance, sees EBITDA margin at low end of range (ATTO) :

  • Reports Q3 (Sep) earnings of $0.31 per share, $0.03 better than the Capital IQ Consensus of $0.28; revenues fell 2.3% year/year to $576.2 mln vs the $501.34 mln Capital IQ Consensus.
  • The Company reiterated its previously disclosed fiscal 2015 revenue growth target of 6% to 9%, and adjusted EBITDA margin in the range of 13% to 13.5%, both in constant currency. Given the increasing adverse effects of the negative macro-economic environment in Brazil, and shifts in business mix, the Company believes it will be at the low end of this margin range.

6:51 am Novavax initiates a Phase 3 clinical trial for its RSV F Vaccine (NVAX) :

Co announced the initiation of a Phase 3 clinical trial, known as Resolve, of its respiratory syncytial virus F-protein nanoparticle vaccine candidate (RSV F Vaccine) in older adults (60 years of age and older).

  • The primary efficacy objective of the Resolve trial is the prevention of moderate-severe RSV-associated lower respiratory tract disease, as defined by the presence of multiple lower respiratory tract symptoms. The trial's objectives, endpoints and statistical approach were finalized based on the FDA's recommendations during the recent End of Phase 2 meeting. The results of a Phase 2 trial in older adults, reported by Novavax in August 2015, provided the basis for the Phase 3 trial design, including the determination of the attack rate, vaccine efficacy and case definitions.
  • Participants are being enrolled and vaccinated in advance of the 2015-16 RSV season, with top-line results expected in the second half of 2016.

6:50 am On the Wires (:WIRES) :

  • Former CEO Mr. Jon Fredrik Baksaas and the Board of Directors in Telenor Group (TELNY) have reached a mutual agreement to terminate Baksaas' consultancy agreement with the Board. Baksaas has also notified the Board that he will refrain from bonus payment for 2015. The decision is effective from today. Petrleo Brasileiro (PBR) estimated Friday's impact of the strike on its production of oil was approximately 115,000 barrels. The Company has scheduled a meeting with the union representatives in order to seek for understandings for the settlement of the 2015 Collective Bargaining Agreement.
  • Trina Solar Limited (TSL) announced that its State Key Laboratory of PV Science and Technology of China has set a new world record for a high-efficiency p-type multi-crystalline silicon solar cell. The 156156 mm2 solar cell reached a total-area efficiency of 21.25%.
  • VTTI Energy Partners LP (VTTI) has been informed by VTTI B.V. that Vitol Investment Partnership Limited, an investment vehicle sponsored by Vitol Holding B.V., which indirectly owns 50% of VTTI B.V., has acquired MISC Berhad's indirect 50% shareholding in VTTI B.V for cash consideration of $830 million. VIP has acquired the shares through VIP Terminals Finance B.V., a wholly-owned indirect subsidiary of VIP.
  • Bombardier Commercial Aircraft (BDRBF) announced that it has signed a Memorandum of Understanding and is in discussions with Abu Dhabi Aviation to work towards the establishment of Abu Dhabi Aviation as an Authorized Service Facility (:ASF) for Q Series aircraft. The final agreement between Bombardier and Abu Dhabi Aviation is subject to acceptance of commercial terms and a final technical audit.
  • Boeing (BA) and Tata Advanced Systems announced a joint venture that will manufacture aerostructures for aircraft and collaborate on integrated systems development opportunities in India.

6:49 am Thompson Creek Metals misses by $0.01, beats on revs (TC) :

  • Reports Q3 (Sep) loss of $0.02 per share, $0.01 worse than the Capital IQ Consensus of ($0.01); revenues fell 38.2% year/year to $141.7 mln vs the $134.77 mln Capital IQ Consensus.
  • Adjusts mid-point of ranges of production guidance: 
    • Concentrate production (000's dry tonnes) now expected to be 140 - 150, down from 140-160. 
    • Copper payable production (000's lb) now expected to be 70,000-80,000, down from 70,000-90,000.
    • Gold payable production (000's oz) now expected to be 210-220, up from 200 - 220.

6:47 am Snap-On increases dividend 15.1% to $0.61 from $0.53/share (SNA) :  

6:47 am MGIC Investment reports October operating statistics, reporting $3.5 bln in new insurance written (MTG) :  

6:46 am Real Industry beats by $0.10, misses on revs (RELY) :

  • Reports Q3 (Sep) earnings of $0.04 per share, excluding non-recurring items, $0.10 better than the two analyst estimate of ($0.06); rev $338.6 mln vs. $368.4 mln consensus.
  • Compared to the second quarter of 2015 and the prior-year period, volumes were down by less than 1% globally with RAEU delivering higher performance in both periods and RANA performing slightly weaker. The six-year lows in prime aluminum prices, which directionally impact the price of aluminum scrap, and the higher proportion of revenues from Real Alloy's tolling business resulted in a larger decrease of revenues than the two comparable periods.

6:45 am DuPont appoints Edward Breen as CEO, effective immediately (DD) : Breen has served as interim chair and CEO of DuPont since October 16, 2015, and joined the company's board in February 2015.

6:43 am Gulfmark Offshore misses by $0.19, misses on revs (GLF) :

  • Reports Q3 (Sep) loss of $0.55 per share, $0.19 worse than the Capital IQ Consensus of ($0.36); revenues fell 52.8% year/year to $60.7 mln vs the $67.66 mln Capital IQ Consensus.

6:41 am Sterling Construction beats by $0.18, misses on revs; appoints Ronald Ballschmiede CFO (STRL) :

  • Reports Q3 (Sep) earnings of $0.09 per share, $0.18 better than the two analyst estimate of ($0.09); revenues fell 7.0% year/year to $176 mln vs the $180.22 mln Capital IQ Consensus, primarily the result of the substantial completion of several large projects in Texas which were completed in the first half of 2015, slightly offset by increased revenues from projects under construction in Utah.
  • Total backlog at Sept 30, 2015 of $718 million was down about 3% from June 30, 2015, but excludes $112 million of projects where the Company was the apparent low bidder but had not yet been awarded the contract (the comparable amount of such projects for the June 30, 2015 backlog was $57 mln); and the estimated gross margin in projects awarded in 2015 has improved to more than 8%.
  • "We expect cumulative gross margins in backlog to continue to increase through the end of this year to more than 7%, and anticipate further improvement in 2016. Our target for general and administrative expenses in 2016 is between 5.0% and 5.5% of revenues as we maintain tight control on costs. In conclusion, our efforts are starting to show meaningful results and we are increasingly confident that Sterling is well positioned to generate improved profitability and shareholder value going into 2016."
  • Ronald Ballschmiede has been named Executive Vice President & Chief Financial Officer effective Nov 9, 2015 and that Kevan Blair will resume his role as Senior Vice President, Corporate Finance.

6:40 am EV Energy reports Q3 (Sep) results, misses on revs; expects distributable cash flow below levels necessary to maintain a $0.50 quarterly distribution (EVEP) :

  • Reports Q3 (Sep) loss of $0.20 per share, including multiple items, may not be comparable to the Capital IQ Consensus of $0.21; revenues fell 54.7% year/year to $38.3 mln vs the $52.08 mln Capital IQ Consensus.
  • Production for the third quarter of 2015 was 9.7 Bcf of natural gas, 212 Mbbls of oil and 526 Mbbls of natural gas liquids, or 153.8 Mmcfe/day. This represents a 13 percent decrease from third quarter 2014 production of 175.8 Mmcfe/d and a 6 percent decrease from second quarter 2015 production of 162.8 Mmcfe/day.
  • Co expects distributable cash flow below levels necessary to maintain a $0.50 per unit quarterly distribution:
    • "As EVEP moves forward into 2016, both the volumes and swap prices of its natural gas and crude oil hedges decline from 2015 levels. In addition, there has been a prolonged downturn in commodity prices over the past year, including the deterioration in future strip prices for crude oil, natural gas, and natural gas liquids. Due to these factors, EVEP expects that its distributable cash flow, beginning in 2016, will be below levels necessary to maintain a $0.50 per unit quarterly distribution, absent a significant, near-term rebound in commodity prices. Management believes it is important to maintain a strong liquidity position during times of low commodity prices until there is more certainty and visibility on the timing and extent of a rebound in commodity prices. Therefore, over the next several months, as the budgeting process for 2016 is completed, EVEP will address its future quarterly distribution levels and policies to align future distributions with projected distributable cash flow. "

6:36 am Hertz Global misses by $0.05, misses on revs; reaffirms FY15 EBITDA (HTZ) :

  • Reports Q3 (Sep) earnings of $0.49 per share, excluding non-recurring items, $0.05 worse than the Capital IQ Consensus of $0.54; revenues fell 4.6% year/year to $2.98 bln vs the $3.07 bln Capital IQ Consensus. 
    • Adjusted Corporate EBITDA for the third quarter of 2015 was $601 million versus $553 million in the third quarter of 2014.
    • As a result of a 2% improvement in fleet efficiency, worldwide Revenue per Available Car Day (:RACD) increased 1% despite a 1% decrease in Total Revenue per Transaction Day (RPD).
  • For the full year 2015, the co has maintained its expected adjusted corporate EBITDA guidance for Consolidated Hertz Global Holdings ($1.45-1.55 bln) and the Worldwide Equipment Rental segment. The company has lowered U.S. RAC net depreciation per unit per month, U.S. RAC fleet capacity growth and Net non-fleet capex guidance for the full year.  
  • Hertz Global will issue preliminary 2016 guidance at the co's Investor Day on Nov. 17, 2015.

6:36 am Rudolph Tech reports that CEO Paul F. McLaughlin to retire on December 30, 2015; BOD appoints Michael P. Plisinski as sucessor CEO, effective immediately (RTEC) : Plisinski has served as the Company's Executive Vice President and Chief Operating Officer since October 2014

6:35 am Sterling Construction appoints Ronald Ballschmiede as EVP and CFO, effective November 9, 2015; Kevan Blair to resume his role as SVP of Corporate Finance (STRL) : Ballschmiede was most recently with Chicago Bridge & Iron (CBI), where he served as Executive Vice President and Chief Financial Officer from June 2006 to March 2015

6:34 am Advanced Drainage Systems CFO Mark Sturgeon to retire on March 31, 2016; Scott A. Cottrill appointed CFO, effective immediately (WMS) : Prior to joining the company, Cottrill most recently held the position of Executive Vice President and Chief Financial Officer at Jeld-Wen

6:33 am 58.com reports a change to its board composition (WUBA) :

  • Co appoints Mr. Eric Zhang as an independent director and a member of the nominating and corporate governance committee of the Board and announces resignations by Messrs.Cai Wensheng, Julian Cheng and Richard Weidong Ji as directors of the Co effective November 6, 2015. Messrs.
  • Cai, Cheng and Ji did not resign due to any disagreement with the Company regarding its business, finance, accounting and/or any other affairs.
  • The Board appointed Mr. Frank Lin as a member of the audit committee to replace Mr. Richard Weidong Ji.
  • BOD appoints Yang Dong and Frank Lin as members of the compensation committee to replace Messrs.
  • Julian Cheng and Richard Weidong Ji. Mr. Yang Dong was also elected as the chairman of the compensation committee.
  • The Board appointed Mr. Eric Zhang as a member of the nominating and corporate governance committee to replace Mr. Richard Weidong Ji.

6:32 am TE Connectivity sells its Circuit Protection Devices to Littelfuse, Inc. (LFUS) for $350 mln; expected to close in 2Q16 (TEL) :  

6:32 am Mallinckrodt plc reports that data presented, suggest that H.P. Acthar Gel reduces disease activity in patients with persistently active Systemic Lupus Erythematosus (MNK) :

Data presented by researchers for Mallinckrodt plc, suggest that H.P. Acthar Gel (repository corticotropin injection) reduces certain measures of disease activity in patients with persistently active Systemic Lupus Erythematosus who are receiving corticosteroid therapy. The pilot study data were presented at a poster session during the 2015 American College of Rheumatology/Association of Rheumatology Health Professionals.

  • The primary endpoint explored the effects of RCI on the skin and joint sub-scores of the hybrid SLE Disease Activity Index (hSLEDAI), while secondary objectives evaluated effects on total hSLEDAI, British Isles Lupus Assessment Group-2004 (:BILAG), Cutaneous Lupus Erythematosus Disease Area and Severity Index (:CLASI) Activity, and tender and swollen 28-joint count scores. The primary endpoint of response (defined by complete resolution of skin or joint activity by hSLEDAI with no new organ system disease by BILAG) was not met.
  • RCI led to significant improvement in secondary efficacy endpoints compared with placebo, including reduction in total hSLEDAI, BILAG, and CLASI Activity scores, decreased tender and swollen joint count, and increased proportion of subjects achieving response as defined by SRI.

6:31 am Apollo Global Management and RCS Capital Corporation (RCAP) amend the sales agreement for RCAP's wholesale distribution business (APO) :

Cos announced that they have mutually agreed to amend the previously announced sale of the RCS Capital (RCAP) wholesale distribution business and certain related entities, to an affiliate of Apollo.

  • Under the amended agreement, RCS Capital will sell its wholesale distribution business, including Realty Capital Securities and Strategic Capital, to Apollo for $6 million in cash. The amended transaction will no longer be conditioned on the closing of a transaction between Apollo and certain affiliates of AR Capital

6:29 am On the Wires (:WIRES) :

  • Cesca Therapeutics (KOOL) will present co's feasibility data on critical limb ischemia at the American Heart Association-Scientific Sessions Conference in Orlando, Florida
  • The Republic of Lebanon confirmed the acquisition of six A-29 Super Tucano turboprop aircraft from Embraer (ERJ) Defense & Security and Sierra Nevada Corporation. The contract includes logistics support for aircraft operation as well as a complete training system for Lebanese Air Force pilots and mechanics. The sale was approved in June by the U.S. State Department

6:26 am Apollo Global Management and AR Capital terminate their planned transaction for Apollo to purchase a controlling interest in AR Global Investments (APO) : Cos announced that they have mutually agreed to terminate the planned transaction pursuant to which Apollo would have purchased a controlling interest in a newly formed company, AR Global Investments, that would have owned a majority of the ongoing asset management business of AR Capital. In conjunction with the transaction's termination, AR Capital is purchasing from Apollo $25 million of preferred stock of RCS Capital Corporation (RCAP) held by Apollo for $25.6 million.

6:24 am RCS Capital provides business update, agrees to sell Hatteras liquid alternatives platform, announces changes to the Board, agrees to certain modifications with its lenders to credit facilities, engages Lazard Freres to explore strategic alternatives (RCAP) :

The co provided an update on recent activities and its pending initiatives:

  • RCS Capital announced that it entered into an agreement to issue $27 million of new Senior Unsecured Promissory Notes, $12 million of which will be issued to RCAP Holdings, LLC, a private holding company under common ownership with AR Capital, LLC, and $15 million of which will be issued to affiliates of Luxor Capital Grou
  • The Company announced it has agreed with its first and second lien lenders under its existing senior secured credit facilities to make certain modification to the facilities, including to permit the incurrence of the Notes among other things.
  • The Company announced that is has signed a letter of intent to sell its liquid alternatives investment management platform (Hatteras) to the Hatteras Funds management group for $5.5 million and the assumption of certain earn-out obligations. Prior to and following the sale of Hatteras, Realty Capital Securities will continue to distribute alternative investments, including non-traded REITs and BDCs, including the full suite of AR Capital products.
  • The Company also announced that Michael Conboy of Luxor Capital Group has been elected to the RCS Capital Board of Directors and as a member of its Executive Committee. The Executive Committee is comprised of Non-Executive Chairman Mark Auerbach and Mr. Conboy. In addition, the Company announced that Marc Rowan and Anthony Civale of Apollo have resigned from RCS Capital's Board of Directors, effective immediately.
  • As previously noted, the Company's Board of Directors has engaged Lazard Freres & Co. LLC to assist in the exploration of options to raise significant capital and to rationalize the Company's capital structure. As part of this process, the independent directors on the Board, led by Non-Executive Chairman Mark Auerbach, will negotiate and approve any proposals derived from the process led by Lazard.

The Company also announced that, given the recently announced strategic initiatives and the time required to incorporate these initiatives into various financial reporting documents, it will utilize the statutory extension period and will now issue its third quarter 2015 earnings release and file its 10-Q filing on or before November 16th.

6:18 am Mannkind misses by $0.01 (MNKD) :

  • Reports Q3 (Sep) loss of $0.08 per share, $0.01 worse than the Capital IQ Consensus of ($0.07). 
  • "For the three and nine months ended Sept 30, 2015, product shipments of Afrezza, our novel rapid-acting inhaled insulin therapy, were $4.1 million and $17.1 million, respectively, which we recorded as deferred product sales from our collaboration with Sanofi. For the quarter ended September 30, 2015, our portion of the loss sharing arrangement with Sanofi related to Afrezza was $14.7 million, which we subsequently financed by way of an advance under the loan facility with an affiliate of Sanofi after September 30, 2015. The amount currently outstanding under the Sanofi loan facility is now $43.7 million, which includes $0.8 million in paid-in-kind interest."

6:17 am AVEO Oncology reports that Chairman Tuan Ha-Ngoc has stepped down, effective November 6, 2015 (AVEO) : Henri A. Termeer, Lead Outside Director of AVEO, has assumed Board leadership responsibilities.

6:17 am Energy XXI misses by $0.30, beats on revs (EXXI) :

  • Reports Q1 (Sep) loss of $1.64 per share, excluding non-recurring items, $0.30 worse than the Capital IQ Consensus of ($1.34); revenues fell 44.1% year/year to $257.8 mln vs the $211.7 mln Capital IQ Consensus. 
  • Production for the 2016 fiscal first quarter averaged 58,900 BOE/d, of which 42,200 was oil. Current production for the fiscal second quarter to date is approximately 54,500 BOE/d, as a result of third-party pipeline downtime during the quarter.
  • Co sees FY16 net production of 35000-40000 Bbls/day.

6:15 am DISH Network beats by $0.02, misses on revs (DISH) :

  • Reports Q3 (Sep) earnings of $0.42 per share, $0.02 better than the Capital IQ Consensus of $0.40; revenues rose 1.4% year/year to $3.73 bln vs the $3.79 bln Capital IQ Consensus. 
    • DISH activated ~751,000 gross new Pay-TV subscribers, compared to ~691,000 gross new Pay-TV subscribers in the prior year's third quarter. Net Pay-TV subscribers declined ~23,000 in the third quarter, compared to a loss of ~12,000 in the third quarter 2014.
    • The co closed the third quarter with 13.909 million Pay-TV subscribers, compared to 14.041 million Pay-TV subscribers at the end of third quarter 2014.
    • Pay-TV ARPU for the third quarter totaled $86.33, compared to the year-ago period's Pay-TV ARPU of $84.39. Pay-TV subscriber churn rate was 1.86 percent versus 1.67 percent for third quarter 2014. DISH added ~13,000 net broadband subscribers in the third quarter, bringing its broadband subscriber base to ~ 608,000.

6:15 am Regal-Beloit beats by $0.01, misses on revs; guides FY15 EPS below consensus (RBC) :

  • Reports Q3 (Sep) earnings of $1.43 per share, $0.01 better than the Capital IQ Consensus of $1.42; revenues rose 6.3% year/year to $882.3 mln vs the $914.15 mln Capital IQ Consensus.
  • Co issues downside guidance for FY15, sees EPS of $5.25-5.35 vs. $5.37 Capital IQ Consensus Estimate.

6:07 am RadNet reports EPS in-line, beats on revs; raises FY15 revs above consensus (RDNT) :

  • Reports Q3 (Sep) earnings of $0.18 per share, in-line with the two analyst estimate of $0.18; revenues rose 13.2% year/year to $208.4 mln vs the $194.25 mln Capital IQ Consensus. Adjusted EBITDA increased 5.6% to $35.3 in the third quarter of 2015 from $33.4 million in the third quarter of 2014.
  • Co issues raised guidance for FY15, sees FY15 revs of $825-850 mln from $785-805 mln vs. $773.92 mln Capital IQ Consensus Estimate.  Co sees FY15 adjusted EBITDA of $125-130 mln vs $125-135 mln prior guidance.

6:05 am Canadian Natrl Res and PrairieSky Royalty to combine their royalty businesses in a CAD 1.8 bln deal (CNQ) :

Through the Transaction, PrairieSky will acquire a substantial portion of Canadian Natural's royalty assets for an aggregate purchase price of CAD 1.8 billion, consisting of CAD 680 million in cash and the issuance of approximately 44.4 million PrairieSky common shares at an ascribed price of $25.20 per common share.

  • Pursuant to the Combination Agreement, Canadian Natural and PrairieSky have agreed that PrairieSky will acquire a substantial portion of Canadian Natural's royalty assets representing approximately 6,700 boe/d or 81%, of Canadian Natural's royalty volumes, for an aggregate purchase price of $1.8 billion, consisting of $680 million in cash and the issuance of approximately 44.4 million PrairieSky common shares. The Assets consist of approximately 5.4 million acres of royalty lands throughout Western Canada, including 2.2 million acres of fee simple mineral title land. The effective date of the Transaction is October 1, 2015 with closing expected prior to year-end 2015.
  • Concurrent with execution of the Combination Agreement, PrairieSky has entered into binding commitments with certain investors to subscribe for an aggregate of 27.0 million subscription receipts at a price of $25.20 per subscription receipt for aggregate gross proceeds of approximately $680 million.
  • Canadian Natural expects to record an after-tax gain on disposition of approximately $700 million, based upon preliminary value allocations. The final determination of the gain on disposition will depend upon the value of PrairieSky common shares at the time the Transaction closes.

6:03 am Commscope beats by $0.03, misses on revs; guides Q4 EPS below consensus, revs below consensus (COMM) :

  • Reports Q3 (Sep) earnings of $0.53 per share, excluding non-recurring items, $0.03 better than the Capital IQ Consensus of $0.50; revenues fell 2.8% year/year to $972.6 mln vs the $1.07 bln Capital IQ Consensus.
  • Co issues downside guidance for Q4, sees EPS of $0.39-0.44, excluding non-recurring items, vs. $0.53 Capital IQ Consensus Estimate; sees Q4 revs of $1.125-1.20 bln vs. $1.28 bln Capital IQ Consensus Estimate.
  • Foreign exchange rate changes negatively impacted sales by 3% in the quarter compared to the prior year period. The addition of the BNS business along with growth in the Enterprise segment was more than offset by lower Wireless and Broadband sales.

6:03 am RedHill Biopharma and IntelGenx Corp announce that they have been granted marketing approval in Germany, for Rizaport 5mg and 10mg to treat migraines (RDHL) :  

6:00 am Collegium Pharmaceutical announces FDA approval for its NDA for Xtampza ER (COLL) :

Co announces that the FDA has granted tentative approval to the Co's NDA for Xtampza ER (oxycodone) extended-release capsules for the management of severe pain.

  • With a tentative approval, the FDA has determined that Xtampza ER meets all of the required quality, safety and efficacy standards for approval but it is subject to an automatic stay of up to 30 months as a result of patent litigation filed by Purdue Pharma, L.P in March 2015.
  • If Co receives a court order that the listed patents are invalid or not infringed, or if Co settles the Purdue litigation prior to the expiration of the 30-month period, the FDA can then provide final approval of Xtampza ER, at which point the product can be marketed.

6:00 am On The Wires (:WIRES) :

  • Marriott (MAR) and Alitrip have joined forces in a move that will make it easier than ever for travelers to book hotel rooms online and on their mobile phones.
  • UTStarcom (UTSI) announced the formal release of NG-PTN product family, the next generation of UTStarcom's packet optical transport network solution to the industry.
  • GE (GE) opened their Middle East Aviation Technology Center to support customers' operations by leveraging data analytics, domain experience and software capabilities to increase productivity, maximize performance and minimize down time for customers using GE's platform for the Industrial Internet.
  • Thomson Reuters (TRI) announced it has integrated all of its FX transaction venues into next-generation FX Trading desktop to streamline access to liquidity for the FX community; includes advanced portfolio order management system for buy-side participants 
  • Stratasys (SSYS) announced that it has teamed with Aurora Flight Sciences to deliver, what is believed to be, the largest, fastest, and most complex 3D printed unmanned aerial vehicle ever produced.
  • ARM (ARMH) announced it is releasing a new suite of products to accelerate secure IoT technology deployments at scale by businesses. The ARM mbed IoT Device Platform products and technologies will be unveiled at ARM TechCon 2015
  • Freescale Semi's (FSL) announced that its popular FRDM-K64F board is available now with comprehensive support for ARM mbed IoT Device Platform technologies, including ARM's new mbed OS operating system.
  • Starbucks (SBUX) announced a significant hiring milestone and investments to further bridge the gap between the military and civilians since only 12 percent of the U.S. public understands the service and sacrifice of the one percent who have served
  • STMicroelectronics (STM) announced that its STM32 family of ARM Cortex-M based microcontrollers, together with the Company's industry-leading sensors, connectivity, and power-management products, is being enabled for the ARM mbed IoT Device Platform with the latest public version of the ARM mbed OS.
  • Lockheed Martin's (LMT) Army Tactical Missile System and Guided Multiple Launch Rocket System Unitary munitions recently underwent successful stockpile reliability tests. 
  • Concur and Booking.com, a unit of Priceline (PCLN), announced a new partnership to enhance business travel worldwide. 
  • BMO Global Asset Management, a part of Bank of Montreal (BMO), launched its first Exchange Traded Funds in Europe, solidifying its position as a global provider of investment solutions focused on meeting the evolving needs of investors. In so doing, BMO becomes the first Canadian bank to offer ETFs in Europe.

5:58 am S&P futures vs fair value: -6.80. Nasdaq futures vs fair value: -9.90. :

5:58 am European Markets : FTSE...6356.13...+2.30...+0.00%.  DAX...10952.69...-36.70...-0.30%.

5:58 am Asian Markets : Nikkei...19642.74...+377.10...+2.00%.  Hang Seng...22726.77...-140.60...-0.60%.

5:22 am Bitauto Holdings beats by $0.01, reports revs in-line; guides Q4 revs below consensus (BITA) :

  • Reports Q3 (Sep) earnings of $0.28 per share, $0.01 better than the Capital IQ Consensus of $0.27; revenues rose 69.3% year/year to $167.6 mln vs the $167.06 mln Capital IQ Consensus.
  • Co issues downside guidance for Q4, sees Q4 revs of $188.8-193.5 mln vs. $200.58 mln Capital IQ Consensus Estimate.

5:05 am Cisco Systems and Ericsson form strategic partnership; incremental rev opportunity of $1 bln or more expected for each company by calendar year 2018 (CSCO) :

Ericsson (ERIC) and Cisco (CSCO) announced a global business and technology partnership to create the networks of the future. The multi-faceted relationship will offer customers the best of both companies: routing, data center, networking, cloud, mobility, management and control, and global services capabilities.

  • Next-generation strategic partnership will drive growth, accelerate innovation, and speed digital transformation demanded by customers across industries.
  • Industry-leading scale and services capability will deliver differentiated customer value for service providers, enterprises, and the Internet of Things ecosystem.
  • Incremental revenue opportunity of $1 billion or more expected for each company by calendar year 2018.

5:02 am Boeing and Jet Airways confirm order for seventy-five 737 MAX 8 airplanes (BA) :  

4:57 am General Electric to divest its Australian and New Zealand Commercial Lending and Leasing Portfolios; terms not disclosed (GE) : GE (GE) has reached an agreement to sell GE Capital's Commercial Lending and Leasing portfolios in Australia and New Zealand to Sankaty Advisors, the global credit affiliate of Bain Capital, advised and partially financed by Deutsche Bank. The transaction includes about $1.7/A$2.4 billion in ending net investment. Terms of the transaction were not disclosed.

4:47 am CytomX Therapeutics highlights data from multiple Probody Pipeline programs; demonstrated preclinical proof-of-concept (CTMX) :

Co presents data on how its Probody technology improves targeting to create safer and more effective therapies across multiple pipeline programs.

  • Demonstrated preclinical proof-of-concept for our Probody technology across a number of our pipeline programs
  • Based on these findings, co has moved CX-072 and CD166 programs into IND-enabling work.
  • In addition, co's T-cell engaging bispecific data illustrate the potential of this promising modality.

4:44 am Eli Lilly reports significant improvement in signs and symptoms of psoriatic arthritis when treated with Ixekizumab (LLY) :

Co announced that psoriatic arthritis patients treated with ixekizumab for 24 weeks achieved significant improvements in signs and symptoms of their disease when compared to placebo, while also experiencing significantly less progression of radiographic structural joint damage, reduced disability when performing certain physical functions and improved skin clearance of plaque psoriasis.

  • In both dosing regimens, ixekizumab-treated patients demonstrated significant improvements compared with placebo in disease activity of PsA as demonstrated by the proportion of patients achieving an ACR20 response at 24 weeks, the study's primary objective.
  • Improvements were experienced by ixekizumab-treated patients as early as one week after treatment initiation. ACR20 represents at least a 20 percent reduction in a composite measure of disease activity as defined by the ACR. Other measures included ACR50 and ACR70, which represent 50 percent and 70 percent reductions in disease activity.
  • At 24 weeks, 62 percent of patients treated every two weeks and 58 percent of patients treated every four weeks with ixekizumab achieved ACR20 compared with 30 percent of placebo-treated patients.

4:42 am On The Wires (:WIRES) :

  • Bombardier (BDRBF) Commercial Aircraft announced that the CS100 aircraft flight test program is close to 100 per cent complete. Only a few tests remain to be completed and Bombardier is on track to have the aircraft certified this year with Transport Canada. Co also confirmed that Riga, Latvia-based Air Baltic Corporation AS will be the first customer to operate the CS300 aircraft when it takes delivery in the second half of 2016.
  • Affiliated Managers (AMG) has entered into a definitive agreements to acquire an equity interests in Ivory Investment Management, to acquire an equity interest in Abax Investments, and with with BlueCrest Capital Management LP, to acquire the majority of BlueCrest's equity interest in Systematica Investments 
  • OmniVision (OVTI) announced the latest advancement in its portfolio of innovative pixel technologies: PureCel Plus and PureCel Plus-S. Co also introduced the OV16860, a new 16-megapixel PureCel Plus-S image sensor.

4:40 am CASI Pharma provides updated data on anti-tumor activity of ENMD-2076 in triple negative breast cancer animal models (CASI) :

Co provides an update on ENMD-2076

  • The data is in line with co's belief that ENMD-2076 may provide clinical benefit to a subset of TNBC patients.
  • TNBC Phase 2 trial in the U.S. has completed patient recruitment and study treatment
  • Efficacy activities were observed in a subset of patients while correlative biomarker analysis with clinical benefit is currently underway

4:36 am Cytokinetics announce late-breaking presentation of COSMIC-HF Trial; study met primary objective (CYTK) :

Amgen (AMGN) and Cytokinetics (CYTK) today announced the presentation of data from the expansion phase of COSMIC-HF (Chronic Oral Study of Myosin Activation to Increase Contractility in Heart Failure), a Phase 2 trial evaluating omecamtiv mecarbil in patients with chronic heart failure, in a Late-Breaking Clinical Trial session at the American Heart Association Scientific Sessions 2015

  • The trial met its primary pharmacokinetic objective and demonstrated statistically significant improvements in all pre-specified secondary measures of cardiac function in the treatment group employing pharmacokinetic-based dose titration.
  • Omecamtiv mecarbil, a novel investigational cardiac myosin activator, enhances cardiac function by increasing cardiac contractility and is being developed for the potential treatment of heart failure.

4:34 am Weyerhaeuser and Plum Creek (PCL) to merge; all-stock transaction followed by $2.5 bln post-closing share repurchase; WY to review strategic alternatives for its Cellulose Fibers business (WY) :

Weyerhaeuser (WY) and Plum Creek (PCL) announced they have entered into a definitive agreement to create the world's premier timber, land and forest products company with more than 13 million acres of the most productive and diverse timberland in the U.S. At closing, the combined company is expected to have an equity value of $23 billion based on current share prices. The combined EBITDA for both companies in 2014 was $2.2 billion.

  • Combination of two industry leaders to create a $23 billion timber REIT with more than 13 million acres of the most productive and diverse timberland in the U.S.
  • All-stock transaction followed by $2.5 billion post-closing share repurchase; Total annual cost synergies of $100 million
  • Funds Available for Distribution per share accretion in the first full year
  • Rick R. Holley to be non-executive chairman; Doyle R. Simons to be president and CEO
  • Weyerhaeuser also announced it will review strategic alternatives for its Cellulose Fibers business 

4:31 am Ignyta acquires exclusive rights to Taladegib Oncology program from Lilly (LLY) (RXDX) :

Ignyta (RXDX) announced the exclusive license of worldwide rights relating to Eli Lilly's (LLY) taladegib oncology development program in exchange for an upfront payment of $2.0 million in cash and the issuance to Lilly of approximately 1.2 million shares of Ignyta's common stock.

  • Ignyta also licensed exclusive worldwide rights to the topical formulation of taladegib, which is a late preclinical program being developed for the potential treatment of patients with superficial and nodular basal cell carcinoma.
  • Exclusive license of Phase 1 clinical development program with compelling proof-of-concept data
  • Concurrent $30 million equity investment in Ignyta by Lilly
  • Lilly to maintain certain rights to develop and commercialize taladegib in combination with other Lilly compounds

4:29 am Pacific Drilling misses by $0.01, misses on revs (PACD) :

  • Reports Q3 (Sep) earnings of $0.19 per share, $0.01 worse than the Capital IQ Consensus of $0.20; revenues fell 5.0% year/year to $260.2 mln vs the $270.23 mln Capital IQ Consensus.
  • Co sees FY15 EBITDA of $575-600 mln

4:25 am American Electric narrows FY16 EPS, in-line with consensus; raises capex guidance (AEP) :

  • Co issues in-line guidance for FY16 (Dec), sees EPS of $3.60-3.80 vs. $3.72 Capital IQ Consensus Estimate. This compares to previous range of $3.45 to $3.85 per share.
  • CAPEX - AEP plans to invest $13 billion in capital from 2016 through 2018 with 96% of that investment in its regulated businesses.
    • AEP increased its 2016 capital expenditure budget to $5 billion.
    • The company forecast its 2017 and 2018 capital investment budgets at $4 billion annually.

4:19 am Curis presents preclinical data from oral small molecule PD-L1/VISTA and IRAK4 programs (CRIS) :

Co announced that its collaborator Aurigene presented preclinical data from two programs

  • The presentation included data from in vitro functional studies, which showed that CA-170 can rescue effector functions of T cells (such as cytokine secretion) that are inhibited specifically by interactions of PD-L1/L2 and VISTA checkpoint proteins but does not impact T cells functions that are modulated as a result of interactions of other checkpoint regulators such as TIM-3, CTLA4, LAG-3 and BTLA with their respective counterparts.
  • Additionally, studies conducted with isolated human T cells demonstrate that short exposures to CA-170 (in the order of a few hours) are adequate to rescue and sustain activation of T cells functions. Daily oral administration of CA-170 resulted in anti-tumor activity in multiple syngeneic tumor models including melanoma and colon cancer but no activity was observed in immune deficient SCID-Beige mice, suggesting that the anti-cancer effects of CA-170 are mediated via activation of immune responses to these cancers.

4:17 am BIND Therapeutics presents data demonstrating ability of accurins to improve efficacy and tolerability of multiple anti-cancer agents (BIND) :

Co reported data demonstrating the efficacy and tolerability of BIND's Accurin platform with multiple anti-cancer agents.

  • BIND researchers and collaborators evaluated the pharmacokinetic profile of BIND-014 in 28 patients with advanced or metastatic cancer and determined that PK properties of BIND-014 are primarily due to retention of encapsulated docetaxel within the vascular compartment and controlled release of docetaxel. These characteristics together with PSMA targeting, potentially lead to greater tumor uptake and improved activity of BIND-014 compared to conventional solvent-based docetaxel.
  • BIND researchers determined that BIND-014, when administered on day 1 of a 21-day cycle with doses ranging from 3.5--75 mg/m2, was well tolerated at all doses studied and has the potential to become a safe antitumor agent without the cardiovascular effects typically associated with docetaxel.
  • BIND researchers demonstrated that BIND-510 exhibited differentiated PK, tumor accumulation, tolerability and anti-tumor activity compared to conventional vincristine. In addition, PSMA expression was demonstrated in the neovasculature in hematological cancers, further supporting the feasibility of developing BIND-510 as a targeted clinical therapy with the potential for reduced toxicity and improved anti-tumor activity compared to currently available treatments.

4:15 am Ignyta reports interim data from RXDX-105 Phase 1 clinical trial; RXDX-105 was well tolerated to date (RXDX) :

Co announced that interim results from the company's ongoing Phase 1 clinical trial of RXDX-105

  • RXDX-105 was well tolerated to date:
    • The most frequent treatment-emergent adverse events were fatigue, vomiting, nausea, decreased appetite, constipation, diarrhea, hypertension and muscle spasms; 
    • Three Grade 3 dose-limiting toxicities were observed: maculopapular rash, fatigue and diarrhea, each of which resolved upon study drug interruption
    • There were no treatment-related serious adverse events. Two Grade 4 adverse events had occurred, consisting of intestinal obstruction and anemia, neither of which was considered to be treatment-related. No Grade 5 treatment-related adverse events or cumulative adverse events were observed
    • The MTD and RP2D had not yet been determined
  • Pharmacokinetic measurements showed increased exposure with increasing dose, with a half-life compatible with once-daily dosing. Dosing in the fed state appears to further increase exposure
  • Exposure was reaching levels expected to be efficacious based on tumor growth inhibition in animal models of RET- and BRAF-driven tumors
  • Tumor regression was observed in six patients treated with 275 mg, including one confirmed partial response (40% reduction) in a patient with non-small cell lung cancer with a KRAS G12C mutation

4:13 am Immunogen reported findings with mirvetuximab soravtansine; Objective response in 90% patients with high amounts of target on cancer cells (IMGN) :

Co reported findings with mirvetuximab soravtansine, its novel folate receptor alpha (FRa)-targeting ADC product candidate

  • Nine of the ten patients with high FRa expression had an objective response (2 complete responses/CRs, 7 partial responses/PRs by RECIST 1.1 criteria). Six of these responders remained on treatment for at least 24 weeks.
  • The six patients with medium expression all had tumor regression. One patient had an objective response (unconfirmed PR) and one had tumor shrinkage with new lesion formation (mixed response/MR). An additional patient remained on treatment for more than six months but did not have an objective response.
  • Four patients had low expression and none had an objective response. One patient was still on treatment at the time of data cut off for presentation.

4:09 am Calithera Biosciences reports new Phase 1 solid tumor dose expansion data of CB-839; continued signs of activity, tolerability, and durability (CALA) :

Co announced new clinical data from the solid tumor expansion cohorts of its lead anti-cancer therapeutic candidate, CB-839.

  • The new data demonstrated stable disease across a variety of tumor types, as well as a single agent partial response in a renal cell carcinoma patient.
  • This patient showed a 32% reduction in target lesions by RECIST with generalized shrinkage of lymph node metastases.
  • Among the fifteen evaluable patients with RCC, nine (60%) had stable disease lasting at least three cycles (63 days) or a partial response, with four patients remaining on study.
  • Among efficacy-evaluable patients across a range of tumor types treated on the current dosing schedule of twice-daily with food, 22 of 50 patients (44%) experienced stable disease or better.
  • Five stable disease patients currently on study have been treated with CB-839 for over 8 months without progression

4:07 am ISIS Pharm reports positive clinical data from Lp(a) lowering drugs (ISIS) :

Co announced positive results from a Phase 2 study of ISIS-APO(a)Rx in which patients with high lipoprotein(a), or Lp(a), achieved reductions in Lp(a) of up to 94%, with a mean reduction of 71 percent.

  • Lp(a) is a known driver of cardiovascular disease.
  • They also announced results from a Phase 1/2a study of ISIS-APO(a)-LRx in which subjects with elevated Lp(a) achieved dose-dependent reductions in Lp(a) of up to 99 percent.
  • ISIS-APO(a)-LRx is a LIgand Conjugated Antisense (:LICA) version of ISIS-APO(a)Rx. ISIS-APO(a)-LRx demonstrated a greater than 30-fold increase in potency in humans as compared to ISIS-APO(a)

4:06 am Loxo Oncology presents data showing LOXO-101 demonstrated promising clinical activity and safety in Phase 1 trial (LOXO) :

Co announced new results from its Phase 1 open-label, dose-escalation trial of LOXO-101, a selective inhibitor of tropomyosin receptor kinase (TRK) signaling molecules, and the first preclinical data for its RET and FGFR programs.

  • Six patients with TRK Fusion Cancers Enrolled
  • all remain on study
  • Three patients with TRK fusion cancers evaluable for efficacy and all show objective responses

4:04 am Lantheus reports data showing Flurpiridaz F 18 demonstrates improved coronary artery disease detection and reduced radiation exposure in women over standard SPECT MPI (LNTH) :

Co announced data from a sub-analysis of its first Phase 3 study of flurpiridaz F 18 for myocardial perfusion imaging

  • The findings show the superiority of flurpiridaz F 18 over standard single photon emission computed tomography (:SPECT) MPI for the assessment of coronary artery disease in women.
  • Superior diagnostic accuracy was observed with flurpiridaz F 18 versus SPECT (77.9% vs. 69.4%). A significantly higher percentage of images were rated as either excellent or good quality with PET imaging, compared to SPECT imaging for stress images and rest images
  • Diagnostic certainty of interpretation (the percentage of cases with definitely abnormal or definitely normal interpretation) was significantly higher for flurpiridaz F 18 PET compared to SPECT (89.8% vs. 74.5%)
  • The agent was safe and well tolerated. Importantly, radiation exposure associated with flurpiridaz F 18 PET imaging was reduced to less than 50% of that associated with standard SPECT MPI

4:00 am Agios Pharma reports data from dose-escalation Phase 1 study of AG-120; safety profile confirmed; signs of clinical and biological activity observed; recommended Phase 2 dose selected (AGIO) :

Co announced the first data from the dose-escalation portion of the ongoing Phase 1 study evaluating single agent AG-120, a first-in-class, oral, selective, potent inhibitor of mutant isocitrate dehydrogenase-1, in advanced solid tumors.

  • Safety Data - The safety analysis conducted for all 62 treated patients as of September 3, 2015 demonstrated that AG-120 was well-tolerated with a favorable safety profile in advanced solid tumors including glioma, IHCC and chondrosarcoma
  • Agios also analyzed efficacy data from 55 response-evaluable patients as of September 3, 2015, which showed: 
    • Treatment with AG-120 showed substantial reduction of the oncometabolite 2-hydroxglutarate in plasma and tumor tissue.
    • Imaging results suggest that AG-120 can lower 2HG in the brain

3:53 am Sanofi-Aventis present results from Phase 3 study of Sarilumab; met both its co-primary endpoints (SNY) :

Sanofi (SNY) and Regeneron (REGN) announced results from a pivotal Phase 3 study of sarilumab, an investigational, human antibody against the IL-6 receptor.

  • The study met both its co-primary endpoints of improvements in signs and symptoms of rheumatoid arthritis (:RA) and improvements in physical function, as well as secondary efficacy endpoints
  • Improvement in physical function at week 12, as measured by mean change from baseline in the Health Assessment Questionnaire-Disability Index (HAQ-DI). The HAQ-DI measures patients' abilities to perform a standard set of daily physical activities.
  • Improvements in signs and symptoms of RA at week 24, as measured by the proportion of patients achieving an ACR20 response (ACR20) were 61% in the sarilumab 200 mg group; 56% in the sarilumab 150 mg group; and 34% in the placebo group, all in combination with DMARD therapy

3:49 am Galapagos provides multiple updates for DARWIN 1 & 2 studies and research with filgotinib (GLPG) :

Co announced announced that it will present the full results from DARWIN 1 & 2 studies in rheumatoid arthritis, as well as other findings from research with filgotinib

  • Rheumatoid Arthritis-Small Molecules, Biologics and Gene Therapy II: Over 12 weeks, filgotinib in combination with MTX demonstrated consistent efficacy on signs and symptoms of active RA with a rapid onset of action. The safety profile was favorable and consistent with previous studies conducted in RA with filgotinib.
  • Over 12 weeks, filgotinib as monotherapy demonstrated clear efficacy in treating the signs and symptoms of active RA with a rapid onset of action. Overall safety profile was favorable and consistent with previous studies conducted in RA with filgotinib
  • Higher age and mild to moderate impairment of renal function has a limited impact on the PK of filgotinib. In severe renal impairment, the exposure to filgotinib's active metabolite is elevated, consistent with its renal elimination pathway. This was not associated with safety signals in these Phase 1 studies.
  • In RA patients treated for four weeks with filgotinib, the lipid profile changed, with a preferential increase in HDL, leading to an improvement in atherogenic index observed at 150 and 300 mg once-daily doses.
  • Treatment with filgotinib for four weeks in RA patients led to reductions in relevant inflammation biomarkers, indicating that JAK1 inhibition is sufficient to address inflammation in RA patients.
  • In RA patients treated for 4 weeks with filgotinib, the absence of effects on numerous immune system factors and the improvement seen in hemoglobin demonstrated the high degree of selectivity for JAK1 of filgotinib in RA patients.

3:43 am Novartis reports Cosentyx demonstrated efficacy in Phase III studies of patients with psoriatic arthritis (NVS) :

Co announced today new results for Cosentyx showing no further progression in joint damage in 84% of patients with psoriatic arthritis. In addition, Cosentyx maintained a treatment response in joint and skin disease, physical function and quality of life in patients over two years of treatment

  • These results from the FUTURE 1 study represent the longest Cosentyx Phase III study in PsA to date. Responses in joint and skin disease, physical function, and quality of life at Week 24, were maintained over two years.
  • After two years of treatment, 67% of patients treated with Cosentyx 150 mg achieved the standard treatment goal of an ACR 20 response
  • In addition, 84% of patients showed no further progression in joint damage as shown by x-ray assessment
  • Cosentyx was well tolerated with a safety profile consistent with that observed in previous studies

3:39 am Eli Lilly and and Incyte (INCY) report Phase 3 data demonstrated significant inhibition of progressive radiographic structural joint damage (LLY) :

Eli Lilly (LLY) and Incyte (INCY) announce detailed data from the pivotal phase 3 RA-BEGIN study, which show investigational baricitinib alone and in combination were superior to methotrexate monotherapy in helping patients achieve clinical remission. 

  • Lilly and Incyte previously announced that the study met its primary objective of demonstrating the non-inferiority of baricitinib monotherapy to methotrexate monotherapy based on ACR20 response rate after 24 weeks of treatment. Additionally, it was announced that baricitinib was superior to methotrexate based on ACR20 response.
  • Improvements compared to methotrexate were seen for baricitinib alone or in combination with methotrexate as early as week 1 for all components of the ACR response (swollen and tender joint counts, pain, patient and physician global assessment of disease activity and physical function). These improvements were maintained at weeks 24 and 52.
  • Baricitinib plus methotrexate also demonstrated significant inhibition of progressive radiographic joint damage versus methotrexate alone in RA-BEGIN, the third phase 3 study of baricitinib in RA to show this finding

3:34 am Novartis reports new 2 year data for Cosentyx demonstrated a sustained response for signs and symptoms of AS (NVS) :

Co announced late-breaking two year results for Cosentyx showing up to 80% of patients with ankylosing spondylitis had no radiographic progression in the spine on x- ray assessment.

  • This is the first time that data on structural spinal progression in AS have been presented for an interleukin-17A inhibitor.
  • In addition, Cosentyx showed a sustained response in improvements of signs and symptoms, physical function and quality of life in AS patients over two years.
  • A sub-study showed up to 80% of ankylosing spondylitis patients treated with Cosentyx had no radiographic progression in the spine over two years

3:30 am Amgen reports Phase 3 results highlighting the potential of novel intravenous calcimimetic treatment option; study met primary and secondary end points (AMGN) :

Co presented the findings from a head-to-head Phase 3 study comparing intravenous etelcalcetide with oral cinacalcet for the treatment of secondary hyperparathyroidism in adult patients with chronic kidney disease receiving hemodialysis.

  • The study met the primary endpoint of non-inferiority of etelcalcetide compared to cinacalcet, measured as the proportion of patients achieving a greater than 30% reduction from baseline in mean pre-dialysis serum intact parathyroid hormone levels during the Efficacy Assessment Phase, defined as the period between weeks 20 and 27.
  • In addition, etelcalcetide was superior to cinacalcet in the secondary endpoints of the proportion of patients achieving greater than 30% (68.2% vs 57.7%) and greater than 50% (52.4% vs 40.2%) reduction in PTH from baseline during the EAP. These differences were statistically significant. There was no difference between the treatment arms in the mean number of days of vomiting or nausea per week in the first eight weeks, another secondary endpoint.

3:27 am Akebia Therapeutics reports Phase 2 data for Vadadustat; achieved its primary endpoints (AKBA) :

Co announced that Phase 2 results for vadadustat in dialysis patients with anemia related to chronic kidney disease were presented

  • The Phase 2 study achieved its primary endpoints of maintaining stable hemoglobin levels over 16 weeks of treatment in all three cohorts of patients converting from recombinant erythropoiesis-stimulating agents to vadadustat, as shown in the chart below and in the poster available online.
  • In addition, the study also demonstrated sustained improvements in iron mobilization across all three cohorts, shown by an elevation in Total Iron Binding Capacity (:TIBC), also illustrated below and in the poster.
  • These results are consistent with those achieved in previous vadadustat studies.

3:25 am ZS Pharma reports positive interim results from a long-term safety study of ZS-9; rapidly lowered serum potassium, maintained normokalemia (ZSPH) :

Co presented interim results from ZS005, a long-term safety and efficacy study of ZS-9, an investigational treatment for hyperkalemia

  • ZS005 Efficacy Results
    • Ninety-nine percent (99%) of patients achieved normokalemia in the Acute Phase on 10 grams TID of ZS-9
    • Mean potassium levels were maintained at 4.6 mEq/L throughout the 12 month Long Term Treatment Phase
    • The primary efficacy endpoint was met with 87 to 92 percent of patients maintained at an average serum potassium =5.1 mEq/L between month 3 and month 12 
    • Normokalemia was maintained with patients receiving once-daily 5 gram (64%), 10 gram (30%), or 15 gram (5%) doses of ZS-9

3:22 am OncoMed Pharma reports preclinical comparison study showing improved anti-tumor and immune responses for Anti-DLL4/VEGF bispecific plus Anti-PD1 vs. either alone (OMED) :

Co new preclinical data for anti-DLL4 combined with anti-VEGF and anti-PD1

  • A series of preclinical experiments compared the impact of anti-DLL4/VEGF bispecific and a triple blockade of DLL4-VEGF-PD1 on anti-tumor immune responses.
  • The combination of anti-DLL4/VEGF and anti-PD1 was found to have more potent anti-tumor and enhanced immuno-oncology activity than either agent alone across a number of measures. The triple blockade of DLL4-VEGF-PD1 significantly inhibited tumor growth with more pronounced tumor regression.
  • The addition of anti-DLL4/VEGF also improved anti-tumor activity of anti-PD1 alone in both PD1 responsive and non-responsive cancers in murine models.

3:18 am Alexion Pharma presents data supporting effectiveness of Soliris (ALXN) :

Co presented new data from a long-term follow-up study evaluating the effectiveness and safety of Soliris in preventing thrombotic microangiopathy-the formation of blood clots in small blood vessels throughout the body-in patients with atypical hemolytic uremic syndrome, a genetic, chronic, ultra-rare disease associated with vital organ failure and premature death. In this observational study, researchers reported a 74 percent lower TMA event rate with ongoing Soliris treatment with labeled dosing compared with discontinuation of Soliris therapy

  • Additionally, in a late-breaking poster session at ASN, researchers reported updated 1-year results from an open-label, single-arm Phase 2 trial of eculizumab in the prevention of acute antibody-mediated rejection in sensitized deceased-donor kidney transplant recipients. Acute AMR is a serious and potentially life-threatening condition that can lead to severe allograft damage resulting in rapid loss of function and possible loss of the transplanted organ.

3:16 am MacroGenics reports interim results of an ongoing Phase 1 dose-escalation study of enoblituzumab; well tolerated and anti-tumor activity observed across several tumor types (MGNX) :

Co announced that interim results of an ongoing Phase 1 dose-escalation study of enoblituzumab were presented in the late-breaking abstract session at the 2015 Society for Immunotherapy of Cancer (:SITC) Annual Meeting

  • Enoblituzumab has been well tolerated at all dose levels tested in the Phase 1 study, with Grade 3/Grade 4 drug-related adverse events in only 4% of patients, no severe immune-related adverse events, and no drug-related treatment discontinuations. The most common AEs have been infusion-related reactions and fatigue. Mild-moderate infusion reactions have been readily managed with conventional supportive care, including administration of corticosteroids and a decreased infusion rate.
  • In this ongoing Phase 1 dose-escalation study of enoblituzumab, monotherapy anti-tumor activity was observed across several tumor types, including patients with prostate and bladder cancer as well as melanoma. Overall, this patient population had been heavily pre-treated, and in the patients with melanoma, all had been treated previously with one or more checkpoint inhibitors

3:08 am Tokai Pharma presents new data highlighting the anti-tumor activity of galeterone in multiple preclinical tumor models (TKAI) :

Co announced the presentation of new data highlighting the anti-tumor activity of galeterone in multiple preclinical tumor models expressing the androgen receptor splice variant AR-V7.

  • The presentation supports earlier clinical findings of positive results with galeterone in men with treatment-nave metastatic castration-resistant prostate cancer whose prostate tumors have C-terminal loss-the loss of the portion of the AR that contains the ligand binding domain. C-terminal loss, generally, and AR-V7, specifically, have been associated with non-response to abiraterone and enzalutamide in mCRPC. The AR-V7 splice variant is believed to be the most common form of C-terminal loss
  • Tokai is evaluating galeterone in ARMOR3-SV, an ongoing pivotal trial designed to determine whether treatment with galeterone results in a statistically significant increase in radiographic progression-free survival as compared to enzalutamide in approximately 148 treatment-nave, AR-V7+ mCRPC patients. Topline results from ARMOR3-SV are anticipated by the end of 2016

2:09 am On The Wires (:WIRES) :

  • An average Southern California Edison (EIX) residential customer's bill would decrease about 6% by the end of March as a result of several actions by the California Public Utilities Commission, including a vote on Thursday for funding SCE's day-to-day operations.
  • Celanese (CE) announced it will increase list and off-list selling prices for the Acetic Acid in North and South Am ($50/MT), Europe (EUR40/MT) and China (CNY200/MT)

2:03 am Zion Oil & Gas provides resource assessment report; range of total estimated prospective recoverable oil volumes ranges from 20.7 - 234.6 million barrels of oil (ZN) :

Co announced the public release of a resource assessment report, also known as a Competent Person's Report prepared by an independent, third-party engineering firm, as required under the terms of its current petroleum exploration license.

  • The range of total estimated prospective recoverable oil volumes for Zion's prospect in the four target horizons ranges from 20.7 million barrels to 234.6 million barrels of oil.
  • The "best estimate" for recoverable oil in the Mid Cretaceous is 27.8 million barrels, Upper Jurassic is 18.3 million barrels, Mid Jurassic is 17.9 million barrels and Triassic is 5.7 million barrels for a total "best estimate" for recoverable hydrocarbons at 69.7 million barrels, if a discovery is made.
Read the rest of the article at finance.yahoo.com
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