7:57 am On The Wires (:WIRES) :

• The Medicines Company (MDCO) initiated study sites and begun enrolling patients in the ORION-1 Phase 2 study to compare the effect of different doses of ALN-PCSsc given as subcutaneous injections in a quarterly or bi-annual dosing regimen in subjects with atherosclerotic cardiovascular disease or risk equivalent ASCVD and elevated LDL-C. Co expects completion of this Phase 2 trial by the end of 2016
• Caladrius Biosciences (CLBS) to out-license the patent and commercialization rights to the Company's CD34 ischemic repair technology. Under the agreement, SPS will receive an exclusive license to the CD34 cell therapy technology for use in AMI and CHF in India and in other territories outside the U.S., including selected countries in Asia-Pacific and Latin America. The license does not include the U.S., Europe, Japan, China or South Korea. SPS will cover all costs associated with the further development of the technology in the assigned regions as well as the costs of related intellectual property maintenance and advancement. Caladrius retains the rights to unfettered, cost-free access to and use of any and all clinical and non-clinical data generated in India.
• Macquarie Infrastructure (MIC) announced investments of more than $115 million in growth projects across its four segments. MIC expects that many of the growth projects completed in 2015, as well as a portion of those to be completed in 2016 through 2019, will constitute property eligible for bonus depreciation under the terms of the recently enacted Protecting Americans from Tax Hikes Act of 2015.
• Axion Power (AXPW) filed an interconnection application with PJM Interconnection, LLC for a site in Sharon, PA. Axion currently has a lease option agreement on the property and is seeking regulatory approval to deploy a 12.5 MW battery energy storage system to engage in the business of frequency regulation. As the application is reviewed, Axion will also apply for site permits, complete preliminary engineering and establish the project rollout plan. Construction and battery manufacture could commence in the latter part of 2016 and startup scheduled in mid-2017, pending timely regulatory approval.
• F-star announced that it has entered into a collaboration and license agreement with AbbVie (ABBV) to research and develop bispecific antibodies in immuno-oncology. Financial terms were not disclosed. Under the collaboration agreement, F-star and AbbVie will create Fcabs against two immuno-oncology targets and generate several mAb2 drug development candidates from these Fcabs. The AbbVie research activities for this collaboration will be led by AbbVie Biotherapeutics.
• Cytokinetics (CYTK) outlined Vision 2020: Empowering Our Future, a strategic initiative designed to deepen and expand its pipeline over the next five years as well as advance a portfolio of muscle-biology directed drug candidates toward late-stage development and commercialization to address urgent unmet needs of people living with conditions characterized by impaired muscle function. Over the next five years, Cytokinetics envisions expanding its portfolio of novel muscle activators by leveraging proprietary and partnered programs, as the company transitions into a mature, commercial-ready organization with multiple, first-in-class compounds for the potential treatment of people living with diseases of impaired muscle function who have few if any treatment options.
• Moderna Therapeutics announced that Merck (MRK) has licensed a vaccine program against an undisclosed viral target, including mRNA 1566 and a set of related novel vaccine candidates, as part of the ongoing collaboration between the companies to discover and develop vaccines and passive immunity treatments against viral diseases using modified messenger RNA. As part of the initial three-year research agreement announced in January 2015, Merck made an upfront cash payment of $50 million and a $50 million equity investment to utilize granted licenses to commercialize five product candidates.

7:45 am On The Wires (:WIRES) :

• ICA Fluor, the industrial construction joint venture of Empresas ICA (ICA) and Fluor (FLR) announced that its ICA Fluor industrial engineering-construction joint venture was authorized by Pemex Transformacin Industrial (Pemex) to proceed with the engineering, procurement and construction (Phase II) of the Madero Clean Diesel project at the Madero Refinery in Tamaulipas, Mexico. ICA Fluor will provide detailed engineering, procurement, construction, commissioning and start-up services for two 25,000-barrel-per-day diesel hydrodesulfurization trains and associated facilities. The project is scheduled to be completed in the first quarter of 2018.
• Brown & Brown (BRO) acquires certain assets of BayRisk; terms not disclosed. Following the transaction, the BayRisk team will relocate to Brown & Brown's existing Lafayette, California office.
• Spectrum Pharma (SPPI) announced the signing of a strategic partnership. As part of this partnership, Spectrum will grant the exclusive rights to develop and commercialize in Canada a franchise of four Spectrum hemato-oncology drugs: ZEVALIN,Injection for intravenous use, Folotyn, Beleodaq for Injection and Marqibo for intravenous infusion. Spectrum will receive $6 million in upfront payments, plus development milestone payments and royalties based on net product sales.
• Neovasc (NVCN) announced the FDA has granted approval for participating physicians to treat patients with its 40mm Tiara in the co's TIARA-I Early Feasibility Trial
• root9B (RTNB) signed a Collaborative Research and Development Agreement with the Department of Homeland Security. According to the terms of the agreement, DHS and root9B will engage in data flow and analytical collaboration associated with cybersecurity, communications reliability, and issues across the spectrum of security coordination, including detection, prevention and mitigation.
• Advanced Accelerator Applications (AAAP) announced an exclusive license agreement with Johns Hopkins University in Baltimore, Maryland to develop and market PSMA-SR6, a receptor ligand of Prostate-Specific Membrane Antigen for clinical therapeutic and diagnostic purposes. The terms of the agreement include payment to Johns Hopkins of an upfront licensing fee, as well as certain milestone and royalty payments.
• Ekso Bionics Holdings (EKSO) announced a new randomized comparative clinical trial is currently underway in Europe. The trial is called "The MOST Study" and is being initialized by Professor Dr. med. F. Hamzei, MD, MHBA, Chief physician of Department of Neurological Rehabilitation, Moritz Klinik.
• HemoShear Therapeutics announced that it would be initiating the next stage of a multi-year collaboration with Pfizer (PFE). Under the terms of the agreement, which combines the scientific and technical expertise of both companies, HemoShear will leverage its proprietary discovery platform, REVEAL-Tx, with the aim of developing a predictive model for preclinical drug-induced vascular injury. Financial terms were not disclosed
• Incyte (INCY) and AstraZeneca (AZN) announced a new collaboration to evaluate the efficacy and safety of Incyte's Janus-associated kinase (:JAK) 1 inhibitor, INCB39110, in combination with AstraZeneca's next generation epidermal growth factor receptor inhibitor, Tagrisso. Under the terms of the agreement, AstraZeneca and Incyte will collaborate on a Phase 1/2 study, to be conducted by Incyte. The Phase 1 part of the trial is expected to establish a recommended dose regimen for the combination of INCB39110 and Tagrisso while the Phase 2 part of the study will assess the safety and efficacy profile. Results from the study will be used to determine whether further clinical development of this combination is warranted.
• Kornit (KRNT) announced that its flagship high-productivity system, the Avalanche 1000, was chosen for the on-demand production of promotional textiles as part of Amazon's Merch program

7:43 am Nevro reports prelim Q4 revs of $32.6-33.1 mln vs $24.03 mln Capital IQ Consensus Estimate, sees FY16 revs $145-155 mln vs $136.46 mln Capital IQ Consensus Estimate (NVRO) :  

7:42 am iRadimed sees Q4 rev above consensus; guides FY16 above consensus; mixed Q1 guidance (limited analyst coverage) (IRMD) :

• Co sees Q4 rev $8.8 mln vs. $8.5 mln consensus
• Co sees FY16 $0.83-0.85 vs $0.82 single analyst estimate; sees revs $39-40 mln vs $37.98 mln single analyst estimate
• Q1 $0.17-18 vs $0.19 single analyst estimate; sees revs $9.0-9.1 mln vs $8.81 mln single analyst estimate

7:42 am Ollie's Bargain Outlet reports holiday sales +23% with comparable store sales +5.6%; raises FY16 guidance (OLLI) :

• Co issues upside guidance for FY16 (Jan), sees EPS of ~$0.69, prior ~$0.66 vs. $0.66 Capital IQ Consensus Estimate; sees FY16 (Jan) revs of ~$760 mln vs. $745.77 mln Capital IQ Consensus Estimate. Comparable store sales growth of approximately 5.5%;
• "We are thrilled with our holiday sales results and the trends in the business over the past few months.... We saw strong sales momentum throughout the holiday season, including the week of Black Friday, Ollie's Army Night, and the weeks before and after Christmas. We are excited by the strong results and momentum of the business heading into a new fiscal year."

7:39 am Apollo Education misses by $0.02, misses on revs; exploring strategic alternves (APOL) :

• Reports Q1 (Nov) earnings of $0.29 per share, excluding $0.82 in non-recurring items, $0.02 worse than the Capital IQ Consensus of $0.31; revenues fell 18.0% year/year to $586 mln vs the $610.42 mln Capital IQ Consensus. 
  • First quarter 2016 University of Phoenix New Degreed Enrollment was 24,500 and Degreed Enrollment was 176,900, compared to New Degreed Enrollment of 39,600 and Degreed Enrollment of 227,400 for the prior year first quarter.
• Co this morning also announced The Board of Directors has made the determination to explore strategic alternatives while the Company continues to execute its ongoing business transformation.
• "The University of Phoenix team is implementing major components of its transformational plan as quickly as possible, and although this is having a near-term negative impact on revenue, we believe speed of execution will help the University return to stability more quickly. Apollo Global continues to expand and grow its network through a combination of high quality acquisitions and organic growth and is on-target for a record year. Finally, we have committed to incremental cost reductions in order to preserve our operating margin during this transformational period."

7:38 am Transgenomic raises gross proceeds of ~$2.2 mln in a preferred stock and warrant private placement, announces conversion of Series A and B Preferred securities and extension of loan maturity date (TBIO) :

Transgenomic sold approximately $2.2 million of units consisting of an aggregate of 2,365,243 shares of Series A-1 convertible preferred stock and warrants to purchase up to an aggregate of 1,773,929 shares of common stock. The units were sold to the investors at a purchase price of $0.93 per unit. The Series A-1 preferred shares are convertible into shares of common stock at an initial rate of 1-for-1, with the conversion rate subject to further adjustment. The warrants are immediately exercisable, have a term of five years and have an exercise price of $1.21 per share of common stock. Each warrant includes cash and cashless exercise features, as well as an exchange feature.

• The co also announced that it has moved to simplify and strengthen its capital structure by entering into a conversion agreement with the holders of its outstanding Series A and Series B convertible preferred stock and by finalizing an amendment to its Loan and Security Agreement with affiliates of Third Security, LLC that extends the maturity date until November 2017.

7:36 am Agios Pharma outlines key 2016 goals and priorities; present first data from Phase 2 DRIVE PK study for AG-348 in PK Deficiency and Phase 1 AG-519 in 1H 2016 (AGIO) :

Expected 2016 milestones for IDH mutant inhibitors in hematologic malignancies:

• Complete enrollment of both 125-patient expansion cohorts for the Phase 1/2 study of AG-221 and Phase 1 study of AG-120 in patients with relapsed/refractory (R/R) acute myeloid leukemia (:AML) in the second half of 2016;
• Initiate a global, registration-enabling Phase 3 study of AG-120 in frontline AML patients with an IDH1 mutation in the second half of 2016 Initiate an expansion arm in high-risk myelodysplastic syndrome patients for AG-221 in 2016 Initiate a Phase 1/2 frontline combination study of AG-221 or AG-120 with VIDAZA (azacitidine) in newly diagnosed AML patients not eligible for intensive chemotherapy in the first quarter of 2016;
• Continue to enroll patients in the following ongoing clinical trials: Phase 3 IDHENTIFY study of AG-221 vs. standard of care chemotherapy in R/R AML Phase 1b frontline combination study of AG-221 or AG-120 with standard-of-care intensive chemotherapy in AML Phase 1 dose-escalation and expansion study of AG-881 in IDH mutant positive hematologic malignancies.

Expected 2016 milestones for IDH mutant inhibitors in solid tumors:

• Initiate a randomized Phase 2 study of AG-120 in IDH1 mutant positive cholangiocarcinoma in the second half of 2016;
• Continue to enroll patients in the following ongoing clinical trials:
  • Expansion phase of the ongoing Phase 1 study of AG-120 in advanced IDH1 mutant positive solid tumors;
  • Phase 1 dose-escalation and expansion study of AG-881 in IDH mutant positive solid tumors.

7:36 am Amicus Therapeutics Provides Full-Year 2016 Strategic Outlook and Financial Guidance (FOLD) :

Amicus expects full-year 2016 net cash spend between $135 million and $155 million. The current cash position is projected to fund operations into mid-2017.

Program Highlights:

• Co has initiated the clinical study ATB200-02 in Pompe patients with a novel treatment paradigm that consists of ATB200.
• SD-101 completed enrollment in Phase 3 study (mid-2016)
  • Top-line Phase 3 data (2H16)

7:36 am Ariad Pharm terminates its Shareholder rights plan (ARIA) : The Rights Plan had the effect of prohibiting any person from acquiring 4.99% or more of the Company's common stock, or if a group or person already owned 4.99% or more of the Company's common stock, from acquiring an additional 0.5% or more of common stock, subject to certain exceptions.

7:35 am Envision Healthcare Holdings issues guidance ahead of JP Morgan Healthcare conference; sees FY16 EPS of $1.43-1.51 vs $1.54 Capital IQ Consensus Estimate (EVHC) :

• Co sees FY16 EPS of $1.43-1.51 vs $1.54 Capital IQ Consensus Estimate; sees Adjusted EBITDA of $715-740 mln.
• Envision expects its 2016 first quarter Adjusted EBITDA to be approximately 20 to 21 percent of its annual outlook, as a result of normal expense seasonality, including higher payroll taxes in the first quarter, particularly for its EmCare segment.

7:34 am Acorda Therapeutics reports prelim Q4/2015 AMPYRA sales and 2016 guidance (ACOR) :

• The co reported Q4 AMPYRA (dalfampridine) Extended Release Tablets, 10 mg unaudited net sales of $121 mln. Unaudited 2015 full-year net sales were $436 mln, an increase of ~19% from 2014 (vs. $485.61 mln Capital IQ Consensus Estimate total sales). Final results are subject to completion of the year-end audit.  At year-end 2015, the Company had cash, cash equivalents and investments of $353 mln (unaudited).
• The Company provided 2016 guidance for AMPYRA net revenue of $475-$485 mln, research and development (R&D) expense of $165-$175 mln, and sales, general and administrative (SG&A) expense of $195-$205 mln. This guidance excludes share-based compensation.
• "We are aiming to complete pivotal trials for CVT-301 in Parkinson's disease and PLUMIAZ in seizure clusters this year; if successful, we plan to file New Drug Applications for both in 2017. We project that these two therapies could generate combined peak sales of over $700 mln. We also expect to perform an interim analysis in our Phase 3 trial of dalfampridine for post-stroke walking deficits."
  

7:32 am Assembly Biosciences appoints Richard Colonno, PhD, as Chief Scientific Officer and Thomas Rollins as Chief Development Officer and head of Microbiome program (ASMB) :

• Richard Colonno, PhD, is an internationally recognized expert with over 30 years of experience in antiviral drug discovery and development. He joins Assembly from Presidio Pharmaceuticals, where he served as CSO and directed the company's hepatitis C antiviral programs, including the discovery and development of the HCV NS5A inhibitor ravidasvir.
• Thomas Rollins joins Assembly from anti-infective drug developer Cubist Pharmaceuticals, where he was Senior Vice President and Global Head, Program and Portfolio Management, chairing the team overseeing global product development.

7:32 am aTyr Pharma provides updates ahead of JP Morgan healthcare conference (LIFE) :

Co provides updates ahead of JP Morgan healthcare conference.  

• "We are pleased by our pipeline progress to date and look forward to further progress in 2016. We expect data from our first Resolaris trial in adult facioscapulohumeral muscular dystrophy (:FSHD) patients at approximately the end of the first quarter that will further inform our clinical strategy moving forward for Resolaris in both muscle and lung indications," said John Mendlein, Ph.D., CEO of aTyr Pharma.
• "With two additional trials progressing in limb girdle muscular dystrophy (:LGMD) 2B and early-onset FSHD, and our second IND candidate selected for the potential treatment of severe lung diseases, we continue to be excited by our Physiocrine-based candidates for patients with rare diseases in need of innovative therapeutic options."
• Co announced an estimated cash balance of approximately $125 million at the end of 2015.

7:32 am Brainstorm Cell Therapeutics enters into collaborative agreement with Hadassah Medical Center in Jerusalem, Israel, to conduct the planned multi dose Phase 2 trial with NurOwn in Amyotrophic Lateral Sclerosis (BCLI) : Co announced that it has entered into a collaborative agreement with Hadassah Medical Center in Jerusalem, Israel, to conduct the planned multi dose Phase 2 trial with NurOwn in Amyotrophic Lateral Sclerosis (:ALS). The trial is expected to enroll up to 24 patients who will receive three consecutive stem cell transplantations in order to explore the safety and efficacy of a multi dose treatment. Commencement of the trial is subject to approval by both Hadassah's Helsinki Committee and the Israeli Ministry of Health.

7:32 am Conatus Pharma initiates phase 2b ENCORE-NF clinical trial of emricasan in patients with NASH fibrosis; top-line results expected in 2018 (CNAT) :

• Co announced the initiation of active patient recruitment in ENCORE-NF, the company's first-in-class, orally-active pan-caspase inhibitor, in approximately 330 patients with biopsy-confirmed nonalcoholic steatohepatitis (NASH) and stage 1 to 3 fibrosis using the NASH Clinical Research Network (:CRN) Histologic Scoring System. 
• The primary endpoint is a biopsy-based improvement in fibrosis by at least one stage vs. placebo using NASH CRN without worsening of steatohepatitis.
• Secondary endpoints include resolution of steatohepatitis without worsening of fibrosis, nonalcoholic fatty liver disease activity score and its components ,collagen and fat content by biopsy, key serum biomarkers, and health-related quality of life, as well as safety and tolerability of emricasan.
• Top-line results from the ENCORE-NF clinical trial are expected in 2018.

7:31 am PRGX acquires Global EDGE's Supplier Information Management; terms not disclosed (PRGX) :  

7:31 am Baxalta to be acquired by Shire (SHPG) for ~$45.57/share, or ~$32 bln ($18.00/share in cash, 0.1482/share in stock) (BXLT) :

Shire plc (SHPG) and Baxalta (BXLT) announced that the boards of directors of both companies have reached an agreement under which Shire will combine with Baxalta. Under the agreement, Baxalta shareholders will receive $18.00 in cash and 0.1482 Shire ADS per Baxalta share. Based on Shire's closing ADS price on January 8, 2016, this implies a total current value of $45.57 per Baxalta share, representing an aggregate consideration of approximately $32 billion. The exchange ratio is based on Shire's 30-day trading day volume weighted average ADS price of $199.03 as of January 8, 2016, which implies a total value of $47.50 per Baxalta share.

• The value of the offer, as of Shire's January 8, 2016 closing ADS price, represents a premium of approximately 37.5% to Baxalta's unaffected share price on August 3, 2015, the day prior to the public announcement of Shire's initial offer for Baxalta.
• The parties expect the transaction to close mid-2016.
• Shire anticipates that it will realize more than $500 million in annual cost synergies (expected to be achieved within the first three years post-closing). These annual cost synergies will be achieved by increasing efficiencies, leveraging the scale of the combined business, aligning to Shire's lean operating model and optimizing the combined R&D portfolio. Further, Shire expects to generate additional revenue synergies and a combined non-GAAP effective tax rate of 16-17% by 2017. Growth is expected to be accelerated by combining capabilities and establishing a global infrastructure that will include a "best of both" commercial model and a presence in over 100 global markets.
• The transaction is expected to be accretive to non-GAAP diluted EPS in 2017, the first calendar year of ownership, and beyond. The combined company is expected to generate annual operating cash flow of $6.0 billion beginning in 2018, underpinning an attractive ROIC that will exceed Shire's cost of capital in 2020.

7:31 am Colliers acquires Groupe Immobilier; terms not disclosed (CIGI) :

• Leading commercial real estate services firm, Colliers International Group Inc. ("Colliers") (NASDAQ:CIGI) (TSX:CIG) announced the acquisition of Groupe Immobilier, a commercial real estate services and landlord representation firm in Montreal, Qubec. Terms were not disclosed.
• This acquisition expands Colliers office landlord representation capabilities across Qubec, augmenting its already strong presence and team. GIMQ will immediately rebrand as Colliers International and their entire team of professionals will be fully integrated into Colliers business and will be based out of Colliers' existing offices in Montral and Qubec City.

7:19 am Sangamo BioSci details its milestones and objectives for 2016 (SGMO) :

• Initiation of the first in vivo genome editing clinical trial. Sangamo expects to begin enrolling subjects into a Phase 1/2 clinical trial for the first application of its In Vivo Protein Replacement Platform approach to assess the safety, tolerability, and efficacy of SB-FIX as a potentially curative therapy for hemophilia B.
• Submission of IND applications for the Company's additional IVPRP-based proprietary programs in hemophilia A and lysosomal storage disorders. Sangamo expects to file IND applications for MPS II in the first half of 2016 and for hemophilia A, Gaucher disease, and Fabry disease in the second half of 2016.
• Submission of IND applications from Sangamo's collaborative programs with Biogen to develop one-time, potentially lifelong treatments for beta-thalassemia and sickle cell disease. Sangamo expects to file the first IND application for its Bcl11a Enhancer knockout approach for beta-thalassemia in the first half of 2016. The companies expect to file an IND application for the same approach for the treatment of sickle cell disease in the second half of 2016.
• Presentation of final data from Sangamo's ongoing Phase 2 clinical trials in HIV. Sangamo expects to present new and updated clinical data from its SB-728-1101 Cohort 3 study in the second half of 2016.
• Ending 2016 with at least $150 million in cash and investments.

7:18 am European Markets Update: DAX +0.6%, CAC +0.4%, FTSE +0.2% (:SUMRX) :

Major European indices trade mostly higher with Germany's DAX (+0.6%) showing relative strength as regional indices rebound from last week's retreat. The Monday session has been pretty quiet in terms of news with headlines limited to reports indicating the Catalan parliament has elected Charles Pugdemont as the new President who will replace Artur Mas. Following his election, the new leader has vowed to continue the region's push for secession from Spain.

• Economic data was limited:
  • Eurozone January Sentix Investor Confidence 9.6 (expected 12.2; previous 15.7)
  • Spain's November Industrial Production +4.2% year-over-year (consensus 3.8%; last 4.1%)
  • Swiss Retail Sales -3.1% year-over-year (consensus 0.3%; last -0.6%)

---Equity Markets---

• Germany's DAX is higher by 0.6% with exporters in the lead. Volkswagen has spiked 4.0% while BMW and Daimler are both up near 1.4%. Financials have also shown strength with Commerzbank and Deutsche Bank holding respective gains of 1.7% and 1.3%.
• In France, the CAC trades up 0.4% amid gains in more than half of its components. Renault and Peugeot are both up near 1.6% while BNP Paribas, Credit Agricole, and Societe Generale have climbed between 0.6% and 1.4%. On the downside, Lafarge is the weakest component, down 1.8%.
• UK's FTSE has added 0.2% with roughly half of its components in the green. Miners and energy names outperform with Anglo American, Glencore, and BP up between 1.4% and 4.3%. Homebuilders Barratt Developments and Persimmon underperform with losses close to 1.0% apiece.

7:16 am Incyte previews J.P. Morgan Healthcare Conference presentation; notes significant progress in its development portfolio with two new development molecules expected to enter the clinic in first-half of 2016 (INCY) : Co previews J.P. Morgan Healthcare Conference today at 1:30pm PT / 4:30pm ET. Co reports two new development molecules-an LSD1 inhibitor and an anti-GITR agonist-added to the portfolio and expected to enter the clinic in first-half of 2016.

7:15 am Quotient announces positive serological disease screening results and provides MosaiQ development program update (QTNT) :

• Based on results achieved to date, Quotient expects to transfer to production assays for the detection of CMV and Syphilis in the first quarter of 2016 and the remaining serological disease screening assays in the second half of 2016.
• Quotient has received final prototype instruments, which are processing assays for development purposes, and field trial instruments are expected to be delivered in the first quarter of 2016. The field trial instruments will be subject to final software development, which we expect to complete in the second quarter of 2016, prior to the commencement of field trials. Field trials in the United States are expected to commence in the fourth quarter of 2016 and regulatory submissions are planned to be filed in the first half of 2017 to obtain required marketing clearances in the United States. Field trials for the serological disease screening test menu expansion are expected to commence in the first half of 2017, both in the United States and in Europe.

7:14 am Cyclacel Pharma provides outline of its key business objectives for 2016 (CYCC) :

2016 Key Upcoming Business Objectives

• Sapacitabine in SEAMLESS: Continue follow-up of patients until the requisite number of events occur, which is anticipated by the end of the first half of 2016; Report top-line results; Following analysis of the mature data set determine submissibility to regulatory authorities for marketing approval; Progress a Paediatric Investigation Plan for sapacitabine with the European Medicines Agency.
• Sapacitabine in myelodysplastic syndromes (:MDS): Initiate a Phase 1/2 trial of sapacitabine in combination with other agents to determine safety and tolerability; Plan a Phase 2 randomized controlled trial (:RCT) of sapacitabine in combination with other agents following review of all relevant clinical data with mature follow-up.
• Sapacitabine and seliciclib in Phase 1 study in patients with advanced solid tumors: Initiate expansion of the Phase 1 study in a breast cancer patient population enriched for BRCA mutations; Report updated Phase 1 data.
• Cyclin Dependent Kinase (CDK) Inhibitor Programs: Report top-line results of the CYC065 Phase 1 trial in solid tumor and lymphoma patients; Report data from seliciclib ISTs when available.

7:12 am Roche Hldg to acquire Tensha Therapeutics for upfront cash payment of $115 mln (RHHBY) : Tensha Therapeutics, a privately-held company based in Cambridge, MA, announced it will be acquired by Roche. Under the terms of the agreement, Tensha's shareholders will receive an upfront cash payment of $115 million, plus additional contingent payments of up to $420 million based on the achievement of certain predetermined clinical and regulatory milestones. The transaction is subject to customary closing conditions and anticipated to close in the first quarter of 2016.

7:11 am Ignyta details its strategic priorities for 2016 (RXDX) :

Ignyta's strategic priorities for 2016 will include:

• With respect to entrectinib, the company's novel, orally available, selective tyrosine kinase inhibitor targeting tumors that harbor activating alterations to NTRK1/2/3 (encoding TrkA/TrkB/TrkC), ROS1 or ALK, continuing to initiate new clinical sites and enroll patients in its STARTRK-2 global, potentially registration-enabling clinical trial of this product candidate;
• With respect to taladegib, the company's novel, orally available, hedgehog/ smoothened inhibitor, initiating one or more pivotal Phase 2 clinical trials in advanced basal cell carcinoma, as well as potentially initiating a Phase 1b basket study for patients with other solid tumors harboring a hedgehog pathway alteration;
• With respect to RXDX-105, Ignyta's multikinase inhibitor with potent activity against such targets as RET and BRAF, achieving clinical proof of concept in patients with activating RET alterations and initiating the Phase 1b portion of the ongoing clinical trial in patients with solid tumors harboring RET or BRAF alterations;
• With respect to RXDX-107, the company's new chemical entity comprising an alkyl ester of bendamustine encapsulated in human serum albumin to form nanoparticles, completing the Phase 1a portion of the ongoing clinical trial and identifying the recommended Phase 2 dose for this product candidate;
• With respect to RXDX-106, the company's potent, pseudo-irreversible inhibitor of TYRO3, AXL and Mer (:TAM) and cMET with potential application in immuno-oncology settings, filing an IND to begin clinical evaluation of this product candidate; and
• With respect to Ignyta's other programs, conducting all activities necessary to advance them toward the clinic, as warranted by the data that Ignyta generates.

7:10 am Apollo Education exploring strategic alternatives (APOL) : Co Board has made the determination to explore strategic alternatives while the Company continues to execute its ongoing business transformation. The Board is currently in discussions that could potentially lead to a change of control of the Company.

7:09 am OvaScience details corporate goals for 2016 (OVAS) :

OvaScience's goals for 2016 include building its global infrastructure to support the availability of the Company's AUGMENT treatment and driving the development of OvaPrimeand OvaTure treatments, with a focus on expanding in key strategic regions such as Japan, Western Europe and Canada.

• AUGMENT Treatment: Building on the positive patient experiences to date, OvaScience plans to expand the network of clinics and clinicians offering the AUGMENT treatment in 2016, focusing in Japan, Western Europe and Canada. The Company also announced it will be working with clinic partners to obtain prospective patient experience data, including the IVI Group, the largest IVF clinic network in the world. In 2016, the IVI Group plans to continue enrollment of patients in its controlled, double-blind, prospective and randomized egg allocation study of the AUGMENT treatment. This adaptive study compares standard IVF to AUGMENT.
  In connection with AUGMENT's recent approval in Japan, OvaScience plans to build the infrastructure to support a non-commercial preceptorship training program in Japan, one of the largest IVF markets in the world.
• OvaPrime Treatment: In December 2015, OvaScience commenced a non-commercial preceptorship training program with the OvaPrime treatment outside the U.S. OvaScience will decide whether to progress the program, based on data, by the end of 2016.
• OvaTure Treatment: In 2016, OvaScience will continue development of the OvaTure procedure, with a goal of further understanding the clinical path forward. The aim is to characterize EggPC-derived mature eggs.

7:09 am Emergent BioSolutions announces prelim 2015 results with upside EPS, revs in-line; issues upside 2016 guidance (EBS) :

• Co reports prelim FY15 results with EPS of $1.54-1.63 vs. $1.51 Capital IQ Consensus Estimate; sees FY15 (Dec) revs of $520-525 mln vs. $524.76 mln Capital IQ Consensus Estimate. For the full year 2015, the company anticipates cash and cash equivalents at year end of ~$310 mln.
  
• Co sees Q1 (Mar) revs of $105 -120 mln vs. $83.00 mln single analyst estimate.
• Co issues upside guidance for FY16 (Dec), sees FY16 (Dec) revs of $600 -630 mln vs. $544.33 mln Capital IQ Consensus Estimate driven by growth in BioThrax sales which are anticipated to be between $305 to $320 mln, continued domestic and international sales of the other Biodefense division products, and continued robust development funding through contracts and grants revenues. The company also forecasts full year 2016 GAAP net income of $75 to $85 mln, non-GAAP adjusted net income of $90 to $100 mln, and EBITDA of $150 to $160 mln.
• 2016-2020 Strategic Growth Plan: The company announced today a growth plan that is intended to advance its mission by expanding and diversifying its business as measured by achieving the following goals by December 31, 2020:
  Annual revenue of $1 bln. >10% of revenue from ex-US markets. Net income CAGR (2016-2020) of >20%. Six products in clinical or advanced development, with at least three being dual use and prioritizing those with third party funding.
  

7:07 am Second Sight Medical Products provides FY15 business highlights (EYES) :

Business Highlights as of December 31, 2015:

• Implanted 21 Argus II Retinal Prosthesis Systems worldwide during the fourth quarter of 2015 for a total of 75 implants in 2015. This compares to 15 implants in the fourth quarter of 2014 and a total of 29 implants in 2014, representing implant volume growth of 40% and 159% respectively
• Added two new implanting centers in the fourth quarter of 2015, bringing the worldwide total to 33 at year end, compared to 18 at the end of 2014
• Successfully implanted four of the five planned subjects in the Company's Dry Age-Related Macular Degeneration clinical trial in the U.K
• As previously reported, expanded Medicare coverage by 10 states to end the year with favorable coverage in 16 states.

7:06 am Media General: Nexstar Broadcasting (NXST) reiterates its commitment to acquire Media General, and to take all necessary actions to consummate a transaction (MEG) : "We remain fully committed to acquiring Media General and with the support of its Board of Directors and shareholders expect to consummate a transaction expeditiously. Despite Meredith Corporation's attempt to recast its proposed combination with Media General as a merger of equals, it is clear that Media General favors a transaction with Nexstar and shares our commitment to seeing it to fruition. As described by Media General in its most recent S-4 filing, Meredith's proposed no-premium merger of equals transaction is 'not competitive with Media General's proposed transaction construct with Nexstar.'

7:05 am Coeur d'Alene Mines reports FY15 silver production at the high end of guidance; sees FY16 production of 33.8 - 36.8 mln silver equivalent ounces (CDE) :

Co announced fourth quarter production of 4.0 mln ounces of silver and 91,551 ounces of gold, or 9.5 mln silver equivalent ounces.

• FY15 production was 15.9 mln silver ounces, at the high-end of Company guidance of 15.2 - 16.1 mln ounces, and 327,908 gold ounces, in-line with Company guidance of 309,000 - 338,000 ounces. Full-year silver equivalent production totaled 35.6 mln ounces, at the high-end of Company guidance of 33.7 - 36.4 mln ounces.
• FY16 Production: Co expects to produce 14.6 - 16.0 mln ounces of silver and 320,000 - 347,000 ounces of gold, or 33.8 - 36.8 mln silver equivalent ounces

7:04 am Microsemi sees Q1 revs at high end of prior $325-329 mln guidance range, vs $327.06 mln Capital IQ Consensus Estimate; completed financing commitments for PMCS acquisition (MSCC) :

Co sees Q1 revs at high end of prior $325-329 mln guidance range, vs $327.06 mln Capital IQ Consensus Estimate. 

• Co also announced that with the pricing of the $450 million senior notes offering, and its credit facility commitments, it has successfully obtained financing commitments to close the acquisition of PMC-Sierra (PMCS). Microsemi expects to close the acquisition on Friday, January 15, 2016.

7:04 am Sotheby's acquires Art Agency, Partners; terms not disclosed (BID) :

• Sotheby's (BID) today announced that it has acquired the art advisory firm Art Agency, Partners.
• AAP is managed by Amy Cappellazzo, Allan Schwartzman, and Adam Chinn.
• "AAP's profitable business helps drive initiatives that are imperative for Sotheby's growth -- improving our leadership position at the high end of the fine art market, bolstering our private sales capability, giving us new growth opportunities in advisory services, and reinforcing the client-first culture in all we do. The AAP leadership team is widely known for its expertise in fine art of the past two centuries, especially in the realm of post-war, contemporary and modern art."

7:03 am Amarin sees Q4 revs $26 mln vs $23.62 mln Capital IQ Consensus Estimate; sees FY16 net product rev $105-120 mln (AMRN) :

• Co issues upside guidance for Q4 (Dec), sees Q4 (Dec) revs of $26.0 mln vs. $23.62 mln Capital IQ Consensus Estimate.
• Sees FY16 net product rev $105-120 mln, excluding licensing revenue (Capital IQ consensus is for total revenue of $136.75 mln).
• The company anticipates that R&D expenses, excluding non-cash costs in 2016 will remain relatively consistent with 2015 levels with the majority of such spending devoted to the ongoing REDUCE-IT trial.

7:03 am Natus Medical lowers Q4 guidance, issues downside Q1 guidance and mixed FY16 guidance (BABY) :

• Co sees Q4 (Dec) revs of ~$100.0 mln, prior guidance $102-105 mln vs. $102.98 mln Capital IQ Consensus Estimate.
• The guidance provided by the Company in October for the fourth quarter of 2015 included expected revenue of ~$4 million under the new Venezuelan Ministry of Health contract. The Company was not able to ship product on the anticipated schedule because the prepayment under the contract was delayed. The Company believes the delay was most likely due to a combination of important national elections that occurred in Argentina in November and Venezuela in December, Argentina's currency devaluation in December as well as national Christmas holidays. The Company now expects to receive prepayment and begin shipments in the first quarter of 2016. The first quarter 2016 guidance includes $5 million of revenue from Venezuela and $60 million of revenue for the full year guidance. Co sees Q1 EPS of $0.34 to $0.35 vs. $0.40 Capital IQ Consensus Estimate; sees Q1 (Mar) revs of $96.5 -97.5 million vs. $105.94 mln Capital IQ Consensus Estimate.
• Co sees FY16 (Dec) EPS of $1.84 to $1.88 vs. $1.87 Capital IQ Consensus Estimate; sees FY16 (Dec) revs of $445 -450 mln vs. $438.78 mln Capital IQ Consensus Estimate.

7:02 am Ocular Therapeutix appoints Jonathan H. Talamo, M.D., as Chief Medical Officer (OCUL) :

• Co announced the appointment of Jonathan H. Talamo, M.D. to the position of Chief Medical Officer.In this role, Dr. Talamo will help advance Ocular's development pipeline, including lead therapeutic candidate, DEXTENZATM.
• Dr. Talamo joins Ocular with more than 25 years of industry experience as an ophthalmologist, innovator and industry consultant. Dr. Talamo has advised many early to late stage ophthalmology companies such as Alcon/Novartis, Allergan, Bausch & Lomb, Shire, as well as Ocular, in the areas of product R&D, clinical trial design, regulatory issues, business development strategy, fund raising and marketing.

7:02 am Can-Fite BioPharma announces 2016 clinical milestones for its pipeline of drugs in six indications (CANF) :

Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE: CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs being developed to treat inflammatory diseases, cancer and sexual dysfunction, today announced its anticipated clinical milestones for calendar year 2016.

Q1 2016

• Rheumatoid Arthritis Phase III EMA Submission for CF101.

H1 2016

• Psoriasis Phase III EMA Submission for CF101.
  
• Liver Cancer Phase II Completion of Patient Enrollment for CF102.

Q2 2016

• NASH Phase II Study Protocol Submission to IRBs for CF102.
• Glaucoma Phase II Data Report for CF101.

Q4 2016

• Sexual Dysfunction IND/Phase I Study Filing with U.S. FDA for CF602

7:02 am Anavex announces positive dose-response data for ANAVEX 2-73 in Alzheimer's disease patients (AVXL) :

Co reported a positive dose-response relationship has been observed in a pre-planned interim analysis of data from the ongoing Phase 2a trial of ANAVEX 2-73 for treatment of mild to moderate Alzheimer's disease.

• The change in Mini Mental State Examination score (MMSE-?) (MMSE difference recorded for every single study subject at the beginning and the end of the five week period) from baseline to 5 weeks as a function of ANAVEX 2-73 dose was examined using linear regression analysis. Based on these findings, it was estimated that an oral dose of 30 mg ANAVEX 2-73 had approximately 80% probability of achieving a +2 points or higher improvement in MMSE score over 5 weeks of treatment.
• Doses in this range have thus far been well tolerated by the study's subjects, with no adverse events reported above grade one.
• Detailed information on the results will be provided in an upcoming scientific meeting.

7:02 am Sorrento Therapeutics announces positive data from Phase 3 studies of Biosimilar Antibodies, STI-001 and STI-002; both STI-001 and STI-002 met their primary endpoints in confirmatory, randomized, controlled, two-part Phase 3 studies (SRNE) :

Co announces that its partner, MabTech Ltd. has successfully completed Phase 3 clinical trials in China for STI-001, a biosimilar/biobetter antibody for Cetuximab and STI-002, a biosimilar/biobetter antibody for Infliximab.

• Both STI-001 and STI-002 met their primary endpoints in confirmatory, randomized, controlled, two-part Phase 3 studies
• During the 501 patient double-blind, randomized Phase 3 trial, STI-001 was well tolerated. Adverse events, especially Grade 3 and 4 AEs were found to be significantly fewer than those previously reported using Erbitux.
• In the current Phase 3 study with 330 patients conducted in China for the treatment of rheumatoid arthritis patients, STI-002 demonstrated an improvement in RA patients' pain symptoms, functions, quality of life and inflammation markers while also inhibiting bone and joint injuries.

7:01 am NeuroMetrix sees Q4 rev above consensus (NURO) :

Sees Q4 revs +93% to $2.7 mln vs $2.21 mln two analyst estimate.

• During the fourth quarter of 2015 the Company shipped 6,675 Quell devices plus electrodes and accessories with an estimated invoiced value of ~$1.5 million in comparison with 4,514 devices plus electrodes and accessories with an invoiced value of $1.0 million in Q3 2015.

7:01 am Alcoa announces $1.5 bln long-term contract with GE Aviation (GE) for jet engine components; note AA reports earnings tonight (AA) :

• Under the deal, Alcoa will supply advanced nickel-based superalloy, titanium and aluminum components for a broad range of GE Aviation engine programs.

7:01 am AbbVie initiates enrollment of six global phase 3 clinical studies for once-daily, pan-genotypic hepatitis c regimen (ABBV) :

• Co announced the initiation of six Phase 3 clinical studies evaluating the safety and efficacy of its all-oral, once-daily, ribavirin-free investigational hepatitis C virus (:HCV) regimen, ABT-493 (an NS3/4A protease inhibitor) and ABT-530 (an NS5A inhibitor) in patients with genotypes 1-6 chronic HCV infection.
• The primary efficacy endpoint of all six studies is rate of sustained virologic response at 12 weeks post-treatment (SVR12).

7:00 am Medivation appoints Marion McCourt as COO, effective on February 1 (MDVN) :

• Co today announced that Marion McCourt will join the company as chief operating officer on February 1, 2016.
• In this position, Ms. McCourt will be responsible for oversight of several functions including commercial operations, medical affairs, manufacturing, quality and corporate efficiency and will report to David Hung, M.D., founder, president and chief executive officer of Medivation.
• Ms. McCourt has more than two decades of wide-ranging executive management leadership experience at some of the world's most innovative biopharmaceutical companies. Most recently, she was a vice president in U.S. commercial operations for Amgen Inc., one of the world's leading independent biotechnology companies, where she was part of the team that drove the Launch Readiness for multiple assets and led the Organized Customer Team.

7:00 am On The Wires (:WIRES) :

• Teleflex (TFX) announced a new group purchasing agreement with HealthTrust in December 2015. The agreement, which became effective Dec. 1, 2015, covers Teleflex's full line of manual ligation products, including the Weck Hem-o-Lok polymer locking system, Horizon Titanium Clip System, Hemoclip Metal Clips and associated appliers.
  
• Exact Sciences (EXAS) announced that Cologuard is now covered as an in-network service for more than 4.5 million enrollees of Anthem BlueCross of California, which is part of the second-largest commercial health insurer in the United States. The co also announced the publication of new modeling data in the peer-reviewed journal Clinical Colorectal Cancer that supports a three-year testing interval for Cologuard. The modeling demonstrates that Cologuard used every three years compares favorably to colonoscopy every 10 years. The analysis shows a colorectal cancer incidence reduction of 57% and mortality reduction of 67%, compared to 65% and 73%, respectively, for colonoscopy every 10 years
• KONE Corporation (KNYJY) will outfit ten stations with its vertical transportation solutions as the Zhengzhou metro line 1 moves into the second development phase of its construction. The order includes 20 KONE MonoSpace elevators and 109 KONE TransitMaster escalators.
• AstraZeneca (AZN) and Moderna Therapeutics announced a new collaboration to discover, co-develop and co-commercialize messenger RNA therapeutic candidates for the treatment of a range of cancers. AstraZeneca, along with its global biologics research and development arm, MedImmune, and Moderna Therapeutics today announced a new collaboration to discover, co-develop and co-commercialize messenger RNA (mRNA) therapeutic candidates for the treatment of a range of cancers. The collaboration is in addition to the agreement announced by the companies in 2013 to develop mRNA Therapeutics for the treatment of cardiovascular, metabolic and renal diseases as well as selected targets in oncology.

6:57 am Asian Markets Close: Nikkei CLOSED, Hang Seng -2.8%, Shanghai -5.3% (:SUMRX) :

The start of the second week of 2016 bore a striking resemblance to the first week of the year as all of the major indices in the Asia-Pacific region ended the day in negative territory. Once again the focus was on China with the Shanghai Composite falling 5.3%, which puts the index back near its September low. Investors did receive the latest inflation data from China, but the numbers were not that far away from expectations. Furthermore, the selling may have taken place in response to an unsatisfied undercurrent of hope for some stimulus action from the People's Bank of China over the weekend. Speaking of the People's Bank of China, the central bank announced a slightly higher fix for the yuan, setting the exchange rate at 6.5626 against 6.5636 from Friday. The PBoC has slowed its devaluation efforts in recent days and it is worth noting that yuan liquidity in Hong Kong has tightened considerably in recent days, sending the overnight Hong Kong Interbank Offered Rate higher by more than 900 basis points to 13.4%. Elsewhere, Japan's Nikkei was closed for Coming of Age Day.

• In economic data:
  • China's December CPI +0.5% month-over-month (expected 0.4%; previous 0.0%); +1.6% year-over-year, as expected (prior +1.5%). Separately, December PPI -5.9% year-over-year (consensus -5.8%; last -5.9%)
  • Australia's ANZ Job Advertisements -0.1% month-over-month (previous 1.1%)
  • New Zealand's November Building Consents +1.8% month-over-month (expected 3.8%; last 5.1%)

---Equity Markets---

• Japan's Nikkei was closed.
• Hong Kong's Hang Seng lost 2.8%, ending at its lowest level since June 2013. Just about every index component settled in the red with Kunlun Energy, China Resources Land, Petrochina, China Shenhua Energy, and CNOOC falling between 4.3% and 7.3%.
• China's Shanghai Composite plunged 5.3%. CITC Securities, Agricultural Bank of China, and Bank of China lost between 2.2% and 6.8%.
• India's Sensex rallied off its opening low, but still ended lower by 0.4%. Mahindra&Mahindra, Wipro, Bharat Heavy Electricals, and ICICI Bank were among the weakest performers with losses between 2.2% and 3.4%. On the upside, Vedanta outperformed, climbing 4.9%.

---FX---

• USDJPY +0.2% to 117.70
• USDCNY -0.4% to 6.5710
• USDINR -0.1% to 66.80

6:57 am Vanda Pharma sees FY15 sales just above estimates; guides FY16 sales in-line (VNDA) :

• Co sees FY15 rev $109.9 mln vs. $108.9 mln consensus.
  • Vanda expects to report fourth quarter 2015 total net product sales from HETLIOZ and Fanapt of ~$31.8 million.
  • HETLIOZ net product sales are expected to be ~$15.1 million.
  • Fanapt net product sales are expected to be ~$16.7 million.
• Co sees FY16 revs $143-153 mln vs $146.51 mln Capital IQ Consensus HETLIOZ net product sales of between $73 and $78 million. Fanapt net product sales of between $70 and $75 million. Non-GAAP Operating expenses, excluding cost of goods sold, of between $125 and $135 million.

6:57 am On The Wires (:WIRES) :

• Trimble (TRMB) announced that a BuildingPoint dealer has been established in Canada. BuildingPoint Canada joins the growing BuildingPoint dealer network that provides focused sales and services with a portfolio of Trimble software and hardware solutions for the Design-Build-Operate lifecycle of buildings.
  
• Teleflex (TFX) announced results of a pre-clinical intravascular study, highlighting Arrow PICC with Chlorag+ard Technology and its ability to significantly reduce thrombus formation when compared to competitive non-eluting antithrombogenic technologies. 
• International Association of Machinists and Aerospace Workers Districts 141 and 142 today announced that members at Hawaiian Airlines (HA) overwhelmingly ratified recent tentative agreements covering ~2,200 Mechanic and Related, Clerical, Office, Stores, Fleet Service and Passenger Service Employees at the carrier. The five-year accords provide pay increases and enhanced job security while holding the line on health care costs. The new contracts also secured profit sharing and other incentive programs.
• Innate Pharma (IPHYF) and OREGA Biotech entered into an exclusive licensing agreement by which OREGA Biotech grants Innate Pharma full worldwide rights to its program of first-in-class anti-CD39 checkpoint inhibitors. Under the terms of the agreement, OREGA Biotech will receive undisclosed upfront payment, milestone payments for preclinical, clinical and regulatory achievements as well as royalties on net sales.
• AMRI (AMRI) announced that Docetaxel Injection (non-alcohol formula) has been approved for commercial manufacture at its Burlington, Mass. aseptic fill-and-finish facility following U.S. Food and Drug Administration's pre-approval inspection for this drug product.
• Superconductor Technologies (SCON) reported its Conductus wire achieved a significant milestone for use in High Field Magnet applications. In the fourth quarter of 2015, STI shipped wire to seven customers for superconducting fault current limiter, high performance magnets and NMR/MRI applications. The shipments included two new customers for power and magnet applications.

6:54 am Eagle Pharma and AMRI (AMRI) enter into an agreement to jointly develop and manufacture several select and complex parenteral drug products (EGRX) :

The co's announced that they have entered into an agreement to jointly develop and manufacture several select and complex parenteral drug products for registration and subsequent commercialization in the United States, which will significantly expand Eagle's portfolio of existing products and product candidates targeting therapeutic areas including oncology, critical care and orphan diseases.

• Under terms of the agreement, AMRI will develop and initially provide cGMP manufacturing and analytical support for the registration of the new product candidates. Eagle will be responsible for advancing the product candidates through clinical trials and regulatory submissions. AMRI will be reimbursed certain costs for formulation activities, process and analytical development and manufacture of regulatory submission batches. Following U.S. Food and Drug Administration ("FDA") approval, AMRI will supply the products to Eagle pursuant to a commercial supply agreement and receive payments based on Eagle's sales of the products. Eagle will be responsible for U.S. commercial distribution of all approved products, once approved by the FDA.

6:53 am Juniper Pharma expands its lead clinical trial, submits pre-IND meeting request with the FDA for its oxybutynin intra-vaginal ring for treatment of overactive bladder (JNP) : JNP announces the expansion of its lead clinical trial, and the submission of a pre-IND meeting request with the FDA for its oxybutynin intra-vaginal ring for treatment of overactive bladder. Co continues to expect top-line data from its Phase 2b lidocaine gel trial in mid-2016, and have advanced all three of its recently disclosed intravaginal ring development programs

6:52 am NovaBay Pharma sees revs Q4 rev above consensus (NBY) :

U.S. sales of its prescription Avenova Lid and Lash Cleanser for the fourth quarter of 2015 are expected to exceed $1.5 million. This represents an increase of ~41% over the third quarter of 2015, with growth driven by record highs for pharmacy-filled prescriptions and products sold directly by eye care specialists. Total revenues for the fourth quarter of 2015 are expected to exceed $1.6 mln vs. $1.29 mln consensus..

• "Insurance reimbursement for Avenova nearly doubled over the past year, growing to approximately 67% of prescriptions being covered by health providers at the end of 2015," added Mr. Sieczkarek. "We expect continued growth in the direct sales channel, however, we anticipate that our prescription business will be the main driver of our long-term sales growth. Supported by the substantial increase in insurance reimbursement coverage, we are focusing our primary sales efforts on building new prescription business, while investing in systems that support prescribing physicians' efforts to educate their patients. This sales model combined with increasing reimbursement, has the potential to provide NovaBay with substantial revenue upside."

6:52 am Seres Therapeutics enters into a collaboration agreement with Nestl Health Science, will receive upfront payment of $120 mln in cash (MCRB) :

The co announced that it has entered into an agreement with Nestl Health Science for the development and commercialization outside of the United States and Canada for its product candidates in development for Clostridium difficile infection and inflammatory bowel disease, including ulcerative colitis and Crohn's disease.

• Under the agreement, Seres granted Nestl Health Science commercial rights in global markets outside of the United States and Canada to SER-109 and SER-262 for CDI, and SER-287 and SER-301 for IBD. In exchange for commercial rights, Nestl Health Science agreed to provide Seres with an upfront payment of $120 million in cash and a series of contingent payments for development and sales milestones and tiered royalties on sales ranging from the high single digits percentages up to the high teens for all products.
• Nestl Health Science agreed to contribute to certain development efforts, including 33 percent of expenses for potential global Phase 3 studies for SER-287, SER-301 and SER-262. The full potential value of the up-front payment, milestones and royalties payable by Nestl Health Science is over $1.9 billion, assuming all products receive regulatory approval and are successfully commercialized. Seres expects to receive a total of $30 million in milestone payments in 2016 associated with the planned initiation of a Phase 1b study for SER-262 in primary CDI and the anticipated start of the Phase 3 trial for SER-109 in recurrent CDI.

6:48 am Navidea Biopharma achieves FY15 guidance, reporting preliminary unaudited Lymphoseek injection sales of $10.2 mln (NAVB) : Total revenue, which will include license and grant revenue, will be provided when the Company reports full-year end results in early March.

6:47 am Science Applications receives $485 mln contract to provide all services necessary to operate the NASA Enterprise Applications Competency Center in Huntsville (SAIC) :  

6:46 am Coherus BioSciences and Baxalta (BXLT) announce that CHS-0214 met its primary endpoint in a confirmatory, double-blind, randomized, controlled, two-part clinical study (CHRS) :

• Coherus BioSciences, Inc. and Baxalta Incorporated today announced that CHS-0214, a proposed biosimilar of Enbrel (etanercept), met its primary endpoint in a confirmatory, double-blind, randomized, controlled, two-part clinical study.
• This ongoing study is evaluating the efficacy and safety of CHS-0214 compared to Enbrel in patients with moderate-to-severe rheumatoid arthritis that is inadequately controlled with methotrexate alone.
• The primary efficacy endpoint was the proportion of subjects achieving ACR20 (20% improvement according to the American College of Rheumatology criteria) at Week 24. The primary endpoint was within the pre-specified margins for demonstrating equivalence of CHS-0214 compared to Enbrel. There were no meaningful differences in the safety and immunogenicity profiles of the two products.

6:46 am Sucampo Pharma granted a sole option to acquire an exclusive license to commercialize CPP-1X/sulindac combination product in North America from Cancer Prevention Pharma (SCMP) :

Co announces an option and collaboration agreement under which Cancer Prevention Pharma has granted Sucampo the sole option to acquire an exclusive license to commercialize CPP-1X/sulindac combination product in North America.

• The ongoing Phase 3 study is a 150-patient, three-arm, double-blind, randomized trial of the combination agent and the single agent comparators.
• Enrollment in the study is expected to be complete in the first half of 2016 and the trial is expected to conclude in 2018, with potential for approval in 2019.
• Under the terms of the agreement, Sucampo will invest $5.0 million in CPP in the form of a convertible note, with a planned additional $5.0 million equity investment in CPP's next qualified financing, which will be either an IPO or a private financing as defined by the agreement.
• In addition, co will pay CPP an option fee of up to $7.5 mln, payable in two tranches.
• CPP will complete the ongoing Phase 3 trial under the oversight of a joint steering committee.
• Upon exercise of its exclusive option, Sucampo would acquire an exclusive license to the product and would be obligated to pay CPP up to an aggregate of $190 million in license fees and milestone payments upon the achievement of specified clinical development and sales milestones.
• Under the terms of the license, co and CPP would share equally in profits from the sale of approved products.

6:46 am Teleflex acquires Nostix; terms not disclosed (TFX) : Nostix is a Boulder, Colorado developer of 'innovative' tip confirmation systems that are used to increase the accuracy of vascular access device placement.

6:45 am Wingstop reports Q4 domestic same store sales +5.9%; raises revenue guidance above consensus (WING) :

Co reports Q4 domestic same store sales +5.9%; now sees FY15 $77.6-77.9 mln $76.9 mln Capital IQ Consensus Estimate. Rev guidance is an increase from prior guidance of between $76.8-77.2 mln.

• "Unit growth is a critical component of our long-term plan and we are thrilled to have opened 133 net new franchised restaurants in 2015, representing 18.7% unit growth. Our pipeline has never been stronger and stands at 530 domestic development commitments as of year-end. This includes our recently-signed 35 restaurant agreement with Sizzling Platter, which is our largest domestic area development agreement to date. In total, 78% of all restaurants."

6:44 am Oncothyreon announces the reitrement of President and CEO Robert L. Kirkman, M.D. effective January 11 (ONTY) :

Oncothyreon's Board of Directors has appointed Chairman Christopher S. Henney, Ph.D., D.Sc. to serve as interim CEO while the company conducts a comprehensive search for a new CEO.

• Additionally, Oncothyreon has appointed two new members to its Board of Directors, Mark Lampert and Gwen Fyfe, M.D. Mr. Lampert is the founder of BVF Partners L.P., affiliates of which, including the Biotechnology Value Fund, L.P., have been shareholders of Oncothyreon since 2011.
• "We remain on track to initiate a potentially pivotal Phase 2 clinical trial of ONT-380 in combination with Xeloda (capecitabine) and Herceptin (trastuzumab) early this year. Our development and regulatory teams are focused on bringing this important medicine to the market for advanced-stage breast cancer patients as soon as possible."

6:44 am Genesco lowers FY16 EPS: holiday comps +5%, +3% in stores (GCO) :

• Comparable sales, including both stores and direct sales, increased 5% for the quarter-to-date period ended January 2, 2016. Same store sales were up 3% and sales for the Company's e-commerce and catalog direct sales businesses increased 20% on a comparable basis for that period.
  • In store comps: Journeys +6%, Schuh -5%, Lids +2%, Johtnson & Murhy +6%
• Co lowers FY16 EPS to $4.30-4.40 from $4.50-4.60 vs $4.54 Capital IQ Consensus, which reflects measures planned to complete the Lids Sports Group's year-long inventory reduction program in the fourth quarter and current challenges in the Schuh Group's business.

6:42 am Sequenom sees FY15 sales just below consensus (SQNM) :

Sees FY15 revs $128 mln vs $130.12 mln Capital IQ Consensus.

• Over 42,000 total commercial diagnostic test samples were accessioned during the fourth quarter of 2015, as compared to ~41,000 in Q3
• Of the total, 37,300 noninvasive prenatal test (:NIPT) samples were accessioned in Q4, as compared to 35,500 in the third quarter of 2015
• Total cash, cash equivalents and marketable securities as of December 31, 2015 were ~$76 million

6:38 am Foundation Medicine Foundation Medicine prelim Q4 revs $26.1 mln vs $25.04 mln Capital IQ Consensus Estimate, sees FY16 revs $110-120 mln vs $126.93 mln Capital IQ Consensus Estimate (FMI) :

The company reported 8,286 clinical tests to ordering physicians in the fourth quarter of 2015, compared to a total of 7,233 tests reported during the fourth quarter of 2014.

• The company expects operating expenses in 2016 will be in the range of $175 and $185 million. The company expects to deliver between 37,000 and 40,000 FoundationOne and FoundationOne Heme clinical tests in 2016. The company also expects to expand upon progress made in 2015 with Palmetto and commercial payers and drive additional coverage decisions.
• As part of its commitment to providing healthcare practitioners with a full suite of analytically validated genomic profiling assays to support precision medicine in oncology, the company plans to expand its offering of molecular information products with the commercial launch of its ctDNA assay in the first quarter 2016.

6:33 am Accuray guides Q2 rev above consensus; reaffirms FY16 guidance (ARAY) :

• Co sees Q2 revs +10% to $107.5 mln vs $101.15 mln Capital IQ Consensus Estimate; Gross product orders are expected to be ~$67 million.
• The co reaffirmed its financial guidance for FY16: total revenue of $395 million to $410 mln vs. $403.6 mln consensus, gross orders of ~$295 million and adjusted EBITDA of $25 million to $35 million.
• "our Incise Multileaf Collimator continues to drive CyberKnife System orders and was included in over 80 percent of our new CyberKnife System orders."

6:31 am Southwest Air reports December traffic; reporting RPMs of 10.0 bln, up 8.6% Y/Y; ASM of 12.1 bln, up 8.3% YoY; Record load factor of 83% (LUV) :

• The Company flew 10 bln revenue passenger miles in Dec 2015, an increase of 8.6 % from the 9.2 bln RPMs flown in Dec 2014.
• Available seat miles increased 8.3% to 12.1 bln in Dec 2015, compared with Dec 2014 ASMs of 11.2 bln.
• The Dec 2015 load factor was a record for the month of Dec at 83% compared with 82.7% in December 2014

2015 Annual

• In 2015, the Company flew 117.5 bln  RPMs, an increase of 8.8% from the 108 bln RPMs flown in 2014.
• For 2015, ASMs increased 7.3% to 140.5 bln, compared with 131 bln in 2014.
• The 2015 load factor was an annual record at 83.6%, compared with 82.5% in 2014.

6:31 am Stage Stores reported holiday comparable sales -2.5% for the ten week period ending January 9, 2016 (SSI) : Co said: "Our holiday sales were in line with our expectations despite continued pressure on stores impacted by the oil and gas industry, the weak peso and one of the warmest holiday seasons on record. We responded to soft traffic and a highly competitive environment with increased promotions and markdowns. As we move into 2016, we remain focused on controlling costs and inventory levels, while we continue to execute on the strategic initiatives that we believe will position us for sustainable long-term growth."

6:31 am MFC Industrial receives all necessary regulatory approvals to complete the acquisition of BAWAG Malta (MIL) : As the Company has received all requisite approvals for the acquisition of the Bank, including the approvals of the European Central Bank and the Malta Financial Services Authority, it expects to complete the acquisition within January 2016, at which time the Bank will be renamed "MFC Merchant Bank Ltd."

6:30 am ONEOK Partners enters into a $1 bln three-year unsecured term loan agreement (OKS) :

Co announced that it has entered into a $1 billion three-year unsecured term loan agreement, which will be used for general partnership purposes, including the repayment of existing borrowings.

• "This agreement effectively refinances ONEOK Partners' 2016 long-term debt maturities and further enhances the partnership's financial flexibility."

6:30 am Navidea Biopharma appoints Anton Gueth as Chairman (NAVB) : Gueth succeeds Gordon Troup, who stepped down but remains on the board

6:29 am Threshold Pharma and Merck KGaA (MKGAY) agree upon terms for the licensing back of all rights to evofosfamide to Threshold (THLD) :

The companies have a global license and co-development agreement for evofosfamide, an investigational hypoxia-activated prodrug for the treatment of cancer, which was discovered and initially developed by Threshold.

• The decision to return rights to evofosfamide to Threshold follows the unblinding of two Phase 3 clinical trials of evofosfamide (TH-CR-406 and MAESTRO) and a previously unplanned, subsequent interim futility analysis of a Phase 2 clinical trial of evofosfamide in patients with non-squamous non-small cell lung cancer (n-s NSCLC). As previously announced, both Phase 3 trials failed to meet the primary endpoint of demonstrating a statistically significant improvement in overall survival.
• Following the topline results from the two Phase 3 clinical trials, Threshold and Merck KGaA, Darmstadt, Germany decided to unblind the Phase 2 clinical trial in n-s NSCLC and conduct an interim futility analysis. An independent Data Safety Monitoring Board conducted the analysis and concluded that the trial is unlikely to reach its primary endpoint of improving overall survival with statistical significance. As a result, further enrollment in this trial will be closed. Additional findings from the interim analysis indicated that evofosfamide plus pemetrexed demonstrated longer progression-free survival associated with a reduction in the risk of progression or death by approximately 30%. No new safety findings were reported. Data for this trial will be finalized and results presented at a future medical meeting.

6:26 am Aquinox Pharma receives official minutes from its December 8 meeting with the FDA's DBRUP, updates on its plans for development of AQX-1125 for the treatment of patients with bladder pain syndrome/interstitial cystitis (AQXP) :

Discussed at the meeting with the FDA's Division of Bone, Reproductive and Urologic Products were guidance and recommendations regarding proposed pivotal trial designs with AQX-1125 for BPS/IC, as well as additional supportive clinical, preclinical and manufacturing activities that could potentially be required for registration. The proposed design for Aquinox's intended first pivotal trial of AQX-1125 remains a three-arm, randomized, double-blind, placebo controlled Phase 3 clinical trial, with 12 weeks dosing followed by an open label extension, to assess the efficacy and safety of AQX-1125 in both male and female BPS/IC patients. Patients will be randomized to receive one of two potential doses of AQX-1125 or placebo. DBRUP confirmed that International Council for Harmonization requirements for the safety database would apply and recommended increasing male patient participation in Aquinox's development program to support the desired label claim. Consequently, Aquinox is evaluating the most efficient approach to meet safety database requirements and male participation, which may increase the size of the planned Phase 3 trials or require additional Phase 2 trials.

• Additional relevant topics discussed included the proposed use of maximum daily pain as a primary endpoint for registration, which DBRUP indicated would be potentially acceptable, subject to consultation with the Division of Anesthesia, Analgesia and Addiction Products upon receipt of a final protocol. Discussion on secondary endpoints was consistent with the company's expectations. Importantly, Aquinox shared with the FDA final audited analysis of the secondary endpoint of urinary frequency from the LEADERSHIP trial demonstrating a statistically significant reduction in urinary frequency with AQX-1125, compared to placebo (p = 0.04), after determining that the previous unaudited analysis had not been normalized for assessing frequency over a 24 hour period. Both Aquinox and the FDA agreed that improvement in urinary frequency, in addition to reduction in pain, would be an important endpoint in assessing the benefit of AQX-1125 to BPS/IC patients.
• Aquinox also announced that it has recently completed a clinical trial demonstrating bioequivalence between AQX-1125 capsules and tablets. All future clinical development will utilize AQX-1125 tablets. Aquinox is also planning to seek Scientific Advice from the European Medicines Agency in the first half of 2016 on topics similar to those discussed with the FDA.

6:15 am Canadian Oil Sands reports the 'overwhelming' rejection of Suncor Energy's (SU) hostile bid (COSWF) : Despite failing to obtain a "significant show of support" by Canadian Oil Sands shareholders as Suncor (SU) indicated was required, Suncor has chosen to extend its bid to January 27, 2016 without any changes. Canadian Oil Sands' Board continues to strongly recommend shareholders not tender to this substantially undervalued and opportunistic bid.

6:07 am Acorn International announces share repurchase program of $2 mln (ATV) :  

6:04 am EXACT Sciences sees Q4 revs slightly below consensus (EXAS) :

• Co issues downside guidance for Q4 (Dec), sees Q4 (Dec) revs of $14.0-14.5 mln vs. $15.91 mln Capital IQ Consensus Estimate.
• 2016 Guidance
  • Co reaffirms in-line guidance for FY16 (Dec), sees FY16 (Dec) revs of $90-100 mln vs. $95.65 mln Capital IQ Consensus Estimate.
  • Based on Exact Sciences' current forecasts, the company is reaffirming its guidance of completing more than 240,000 Cologuard tests and generating between $90-100 million in revenue in 2016.
  • This represents a greater than 130-percent year-over-year increase in the number of Cologuard tests completed.

6:03 am IHS announces enters agreement to acquire Oil Price Information Service for $650 mln (IHS) : OPIS is a provider of U.S. refined petroleum pricing data, news and analytics. OPIS information primarily serves the downstream energy market and helps to further diversify the IHS Energy portfolio. The acquisition is subject to regulatory approval, including expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. More details will be provided on the IHS fourth quarter and year-end 2015 earnings call on January 12, 2016.

6:02 am Sorrento Therapeutics forms an exclusive partnership w/ the Karolinska Institutet to perform immuno-oncology research and to develop new natural killer cell-based therapies. (SRNE) : Under the agreement, Sorrento will sponsor preclinical and clinical R&D programs focused on NK biology as well as adoptive NK cell therapies and, in return, obtain full rights to the resulting discoveries and developments. The research will be performed at KI, but there will also be an active research exchange with Sorrento R&D in San Diego.

6:01 am Synergy Pharma announces positive phase 1b data with its second uroguanylin analog, dolcanatide, in a double-blind, placebo-controlled, four-week study evaluating 28 patients with mild-to-moderate ulcerative colitis (SGYP) :

Co announces positive phase 1b data with its second uroguanylin analog, dolcanatide, in a double-blind, placebo-controlled, four-week study evaluating 28 patients with mild-to-moderate ulcerative colitis.

• Analysis of the data indicates clear signals of improvement in dolcanatide-treated patients compared with placebo-treated patients.
• Dolcanatide was also safe and well tolerated.
• Co remains on-track to file its first NDA with plecanatide for CIC this month and its second NDA with plecanatide for IBS-C by the end of this year.

5:59 am S&P futures vs fair value: +5.30. Nasdaq futures vs fair value: +9.30. :

5:58 am European Markets : FTSE...5901...-11.40...-0.20%.  DAX...9864.73...+15.40...+0.20%.

5:58 am Asian Markets : Nikkei...Holiday.........  Hang Seng...19888.5...-565.20...-2.80%.

5:58 am Shanghai... -5.33% (FXI) :  

5:44 am On The Wires (:WIRES) :

• AZMM announced that its employees' devices will be secured with MobileIron (MOBL).
• TowerJazz (TSEM) and PIXELPLUS announced they have collaborated to produce a state-of-the-art HD and FHD SoC security sensor with unprecedented performance using TPSCo's leading 65nm CMOS image sensor process. Production is expected to start at the beginning of 2016
• TeleCommunication Systems (TSYS) announced that the company has expanded its presence in the Middle East by adding two of the largest mobile network operators in the region to its customer portfolio. The combined value of the two contracts is approximately $3 million.
• JLL (JLL) announced its acquisition of Cobertura SA. This is a further example of JLL's disciplined acquisition strategy targeting key growth opportunities with complementary high-margin business additions that maximize added-value and minimize operational overlap.
• P&V Group, a co-operative insurer, and Guidewire Software (GWRE) announced that P&V has extended its selection of Guidewire products to include Guidewire PolicyCenter and Guidewire BillingCenter
• Trina Solar (TSL) announced that it successfully completed and connected three distributed generation projects totaling 27 MW to the grid in Suqian City, Jiangsu Province, China at the end of December 2015.

5:02 am On The Wires (:WIRES) :

• As part of its transformation into an auto and mobility company, Ford (F) is introduced FordPass -- a platform that reimagines the relationship between automaker and consumer.
• Sanofi (SNY) and Warp Drive Bio, a privately held biotechnology company using the molecules and mechanisms of nature to discover and develop transformative medicines, today announced that they have extended and reshaped their existing collaboration utilizing Warp Drive's proprietary SMART and Genome Mining platforms to discover novel oncology therapeutics and antibiotics. New collaboration to provide warp drive funding and milestones in excess of $750 mln
• China Sunergy (CSUN) and Z-One Holding announced an agreement to form a joint venture to market and sell the full range of CSUN's solar products and provide high value-added PV solutions in the Middle Eastern and African markets. Under the terms of the agreement, the joint venture, CSUN Solar MEA FZC, will be owned 60% by China Sunergy, and 40% by Z-One Holding.
• ATA Inc. (ATAI) announced that the China Certified Tax Agents Association has engaged ATA to be its service provider for the computer-based National Tax Adviser Occupational Qualification Exam.
• FXCM (FXCM) announced its partnership with PFSOFT, a developer of professional trading software for banks, prime brokers and retail brokers. FXCM will provide trade execution and market data to the PFSOFT Protrader multi-asset solution through FIX API.
  

4:53 am Air France-KLM reports Dec traffic fell 1.1% YoY; issues statement regarding article published about co's 2015 results; notes FY results not finalized (AFLYY) :

Co reports Dec Traffic highlights

• The negative impact of the Paris attacks on December revenues is estimated to be around 70 million euros, with significant easing during the last two weeks.
• Booking trends in December were in line with a progressive recovery
• 6.2 million passengers, down 1.1%
• Network-wide load factor stable in spite of Paris terrorist attacks
• Load factor for both North America and Asia networks, notably Japan routes, impacted by the Paris terrorist attacks

Additionally, co issues statement following the publication of an article on the website of les Echos.fr on January 10.

• TheFrench newspaper Les chos has published information on its website about theAFKLM group's results forecast for 2015.
• The group would like to state that itneither publishes nor makes comments on its results forecast, that the year'saccounts have not been finalized and that they will be published on February 18.

4:46 am Novartis signs licensing agreement with Surface Oncology (NVS) :

Novartis announced that it is adding to its diverse and deep immuno-oncology pipeline through a strategic alliance and licensing agreement with Surface Oncology.

• The agreement gives Novartis access to four pre-clinical programs that target regulatory T cell populations, inhibitory cytokines, and immunosuppressive metabolites in the tumor microenvironment.
• These programs will be explored as monotherapies and in combination with other complementary therapies in Novartis' immuno-oncology and targeted therapy portfolios.

4:38 am Five Prime Therapeutics and GlaxoSmithKline's (GSK) provide encouraging data on FP-1039 program (FPRX) :

Five Prime Therapeutics (FPRX) provided an update on GlaxoSmithKline's (GSK) ongoing Phase 1b clinical trial of FP-1039/GSK3052230, an FGF ligand trap, in patients with squamous non-small cell lung cancer and mesothelioma.

• Co's Commentary: "We are encouraged by the preliminary data we have recently reviewed from the mesothelioma arm of the study and look forward to seeing the results as additional patients are enrolled and followed. The majority of mesothelioma tumors express high levels of FGF-2, so our FGF ligand trap represents a rational therapeutic approach, and patients currently have limited treatment options. If we see similar results once we have full, mature data for Arm C, we will seek to regain rights for FP-1039 in the U.S., Canada and the E.U. from GSK, as mesothelioma could represent a potentially attractive market opportunity for Five Prime."
  

4:34 am China Lodging reports preliminary Q4 hotel operation results (HTHT) :

Operating Metrics (Y/Y):

• Blended Occupancy rate: 84% vs 87% 
• Blended Average daily room rate (in RMB): 177 vs 176
• Blended RevPAR (in RMB): 149 vs 153 

4:29 am Arch Coal files Chapter 11 bankruptcy, agrees on terms of debt restructure deal with Senior lenders (ACI) :

Co announced that it has reached an agreement with a majority of the lenders under its $1.9 billion first lien financing facility to significantly restructure the company's debt load. Arch has entered into a restructuring support agreement with the members of an ad hoc group of lenders that hold more than 50% of the company's first lien debt.

• Under the terms of the agreement, the lenders have agreed to support a restructuring transaction that will eliminate more than $4.5 billion in debt from Arch's balance sheet and position the company for long-term success.
• In order to facilitate this financial restructuring, Arch and substantially all of its wholly-owned domestic subsidiaries have today filed voluntary petitions for reorganization under Chapter 11 of the Bankruptcy Code in the United States Bankruptcy Court for the Eastern District of Missouri. The company and the ad hoc group have agreed to the principal terms of a Chapter 11 plan of reorganization, which will be subject to approval by the Bankruptcy Court.
• The company believes it has sufficient liquidity to continue its normal mining activities and to meet its obligations in the ordinary course. Arch had more than $600 million in cash and short-term investments as of January 11, 2016, and expects to receive $275 million in debtor-in-possession (:DIP) financing from members of the ad hoc group of lenders on terms and conditions set forth in the DIP term sheet and DIP credit agreement filed with the Bankruptcy Court and contemplated by the restructuring support agreement among the company and the lenders.

4:28 am CGG provides FY15 financial update; sees net debt at $2.5 bln (CGG) :

CGG anticipates year-end 2015 net debt to be at $2,502 mln, to be compared to $2,538 mln by end of September 2015.

• The Group's Liquidity, corresponding to the sum of the cash balance and the undrawn portion of the revolving credit facilities, is expected to amount to $420 million by December-end, to be compared to $440 mln by end of September 2015.
• Over the fourth quarter, the cash performance was notably sustained by strong multi-client revenue at $242 million, by Sercel sales at $102 million, and by a tight cost and working capital management
• Vessel utilization rates
  • The vessel availability rate in Q4 2015 was 92%.
  • This compares to a 87% availability rate in the fourth quarter of 2014 and a 84% rate in the third quarter of 2015.
    

4:26 am CTI BioPharma reports positive progress of lead clinical programs; provides outlook for 2016 (CTIC) :

Co announced positive progress of its lead clinical program in addition to several key business priorities for 2016. In January 2016, CTI BioPharma announced the completion of the rolling NDA to the FDA for pacritinib, an investigational oral kinase inhibitor with specificity for JAK2, FLT3, IRAK1 and CSF1R.

• 2016 Key Objectives
  • Seek U.S. regulatory approval and launch pacritinib.
  • Complete enrollment and report PERSIST-2 topline results.
  • Initiate trial in second indication for pacritinib.
  • Initiate registration-directed trial for tosedostat. CTI BioPharma plans to consult with the FDA and European Medicines Agency regarding a registration-directed strategy for tosedostat, including the potential to utilize the results from the ongoing investigator-sponsored LI-1 trial to support registration and approval. If positive, these discussions could help enable the start of a pivotal program in 2016.
  • Complete enrollment in PIX306. CTI BioPharma expects to complete enrollment in the ongoing PIX306 post-marketing commitment Phase 3 study of PIXUVRI in the fourth quarter of 2016.
    

4:23 am UTStarcom appoints Tim Ti as CEO effective immediately; previously served as the CEO of Virtual Gateway Labs, a subsidiary of UTStarcom (UTSI) :  

4:21 am ING Groep amends accounting approach for NN Group anchor investment; no impact on ongoing operating results (ING) :

ING Group announced today that it will change its accounting approach with regards to the anchor investment transaction related to the divestment of NN Group made in 2014.

• This change will be reflected in ING Group's 2015 Full Year reporting and comparative figures.
• The amendment has no impact on ING Bank, ING's Bank's Underlying net result or on ING's ongoing operating results, capital or dividend plans.

4:16 am Sanofi and Innate Pharma (IPHYF) collaborate on new bispecific NK cell engagers; Innate Pharma eligible for up to 400m in milestones as well as royalties on net sales (SNY) :

Sanofi and Innate Pharma announced that they have entered into a research collaboration and licensing agreement to apply Innate Pharma's new proprietary technology to the development of innovative bispecific antibody formats engaging natural killer cells to kill tumor cells through the activating receptor NKp46.

• Sanofi and Innate Pharma will work together on the generation and evaluation of up to two bispecific NK cell engagers, using technology from Innate Pharma and Sanofi's proprietary bispecific antibody format as well as tumor targets. Under the terms of the license agreement, Sanofi will be responsible for the development, manufacturing and commercialization of products resulting from the research collaboration.
• Innate Pharma will be eligible to up to 400m in development and commercial milestone payments as well as royalties on net sales

4:14 am MiMedx Group acquires Stability Biologics; updates guidance following acquistion (MDXG) :

Co announced that it has signed a definitive agreement to acquire Stability, d/b/a Stability Biologics, a provider of human tissue products to surgeons, facilities and distributors serving the surgical, spine and orthopedics sectors of the healthcare industry. The Company also announced its revised outlook for 2016, which includes the expected impact of the acquisition on forecasted 2016 results.

• MiMedx expects the transaction to be accretive to Full Year Adjusted EPS in 2016, and it projects the 2016 Stability Biologics revenues generated from its processed tissue and bone product sales and distribution to be at least $15 million.
• The transaction is subject to customary conditions of closing, which is expected to occur by mid-January 2016.
• Co issues upside guidance for FY16 (Dec), sees EPS of $0.33-0.37 vs. $0.30 Capital IQ Consensus Estimate; sees FY16 (Dec) revs of $260-270 mln vs. $249.52 mln Capital IQ Consensus Estimate.
• Q4 2015 revenue of $51.8 mln in upper range of MiMedx Q4 2015 guidance
  • The Company recorded record revenue for the year ended December 31, 2015 of $187.3 million, a $69.1 million or 58% increase over 2014 revenue of $118.2 million.
  • The Company recorded record revenue for the 2015 fourth quarter of $51.8 million, a $12.3 million or 31% increase over 2014 fourth quarter revenue of $39.6 million.
    

4:00 am On The Wires (:WIRES) :

• Federal-Mogul Motorparts, a division of Federal-Mogul Holdings (FDML) and M1 Concourse announced they have forged a robust partnership that has resulted in Champion becoming the official sponsor of a new, state-of-the-art, 1.5 mile automotive performance track in Pontiac, Mich. M1 Concourse is a $40 million-plus development being built on an 87-acre former General Motors plant site in Pontiac, Mich.
• SAP SE (SAP) and Accenture (ACN) are joining forces in the core and industry development and go-to-market of SAP Business Suite 4 SAP HANA, the next-generation business suite from SAP built on the industry's most advanced in-memory platform.

3:58 am Ariad Pharm elects Alex Denner as Chairman (ARIA) :

Co announced the election of Alexander J. Denner, Ph.D., as chairman of its board of directors.

• Denner joined the ARIAD Board of Directors in February 2014 and most recently led the Board's search committee to select the Company's

3:56 am Illumina forms new company GRAIL for early detection blood-based screening; considered significant development in the war on cancer (ILMN) :

Co announced GRAIL, a new company formed to enable cancer screening from a simple blood test. Powered by Illumina sequencing technology, GRAIL will develop a pan-cancer screening test by directly measuring circulating nucleic acids in blood.

• Detecting cancer at the earliest stages dramatically increases long-term survival, hence the successful development of a pan-cancer screening test for asymptomatic individuals would make the first major dent in global cancer mortality.
• GRAIL's unique structure enables it to take on this grand challenge. GRAIL has been formed as a separate company, majority owned by Illumina. GRAIL is initially funded by over $100 million in Series A financing from Illumina and ARCH Venture Partners, with participating investments from Bezos Expeditions, Bill Gates and Sutter Hill Ventures.
• GRAIL's unique relationship with Illumina provides the ability to economically sequence at the high depths necessary to create a screening test with the required sensitivity and a hoped for level of specificity never before achievable for cancer screening.

3:53 am NanoString Technologies sees Q4 revs above consensus (NSTG) :

• Co issues upside guidance for Q4 (Dec), sees Q4 (Dec) revs of $21.1-22.1 mln vs. $20.89 mln Capital IQ Consensus Estimate.
• Co issues upside guidance for FY15 (Dec), sees FY15 (Dec) revs of $61.5-62.5 mln vs. $61.15 mln Capital IQ Consensus Estimate, versus prior guidance of $60.0-63.0 mln

3:49 am Arbutus Biopharma issues update on recent progress and expected 2016 milestones; Phase II single dose HBsAg reduction data expected in 3Q16 (ABUS) :

Cended 3Q15 with $206 mln in cash, which is expected to fund company operations into late 2018.  In 2016, look forward to delivering pipeline progress, including the recently initiated Phase II study of ARB-1467 in HBV-infected patients, for which expect to report HBsAg reduction results from single dose in 3Q16 and from the multiple dose portion of the study in 4Q16

• Phase II multidose study of ARB-1467 in HBV patients was initiated in 2015; Phase II single dose HBsAg reduction data expected in 3Q16; Four HBV products in clinical development by year-end

Upcoming Arbutus Pipeline Milestones

• 2016: Initiate clinical immune biomarker study for TLR9 agonist ARB-1598 in chronically infected HBV patients, 2016- Preclinical data release on multiple pipeline programs, including results from preclinical combination studies of proprietary pipeline candidates; 1H16= Phase II results for TKM-PLK1 in HCC; 3Q16- Single dose HBsAg reduction data from the ARB-1467 (RNAi) Phase II trial in HBV-infected patients; 4Q16- HBsAg reduction data from the multiple dose portion of the Phase II trial testing ARB-1467 in HBV-infected patients 
• 2H16: File IND (or equivalent) for cccDNA formation inhibitor, file IND (or equivalent) for core protein/capsid assembly inhibitor and file IND (or equivalent) for ARB-1740 (RNAi)
• 2017: Initiate clinical combination studies with two or more proprietary product candidates. 
• Alnylam's (ALNY) LNP-enabled patisiran is currently in Phase III for the treatment of transthyretin-mediated amyloidosis (ATTR amyloidosis). Alnylam has announced that it expects to submit a New Drug Application (:NDA) for patisiran in 2017.

3:43 am Vertex Pharma provides 2015 net CF product revenues of ~$980 mln, an increase of more than 110% YoY (VRTX) :

Co provides preliminary financial results for 2015 and a financial outlook for 2016.

• Vertex expects to report total 2015 net product revenues of approximately $980 million, including fourth quarter 2015 net product revenues of ~$180 million for KALYDECO and ~$220 million for ORKAMBI.
• As of December 31, 2015 more than 4,500 people had begun treatment with ORKAMBI in the U.S.
• Vertex also provided 2016 net product revenue guidance of $670 to $690 million for KALYDECO and guidance of $1.18 to $1.23 billion for non-GAAP operating expenses, excluding costs of revenues.
• The company expects to provide net product revenue guidance for ORKAMBI during 2016 after gaining additional information on the launch of ORKAMBI in the U.S.

3:39 am Immunogen provides anticipated milestones for 2016 (IMGN) :

Events anticipated in 2016 include:

• Mirvetuximab soravtansine -- the first folate receptor a (FRa)-targeting ADC.
  • Meeting with regulators in 1H2016 on the mirvetuximab soravtansine development program, including the design of the second stage of the FORWARD I trial.
  • Presentation of clinical data from the 40-patient ovarian cancer cohort at a medical meeting in 2Q2016.
  • Presentation of clinical data from additional expansion cohorts.
  • Advancing FORWARD I and FORWARD II. ImmunoGen plans to ultimately have more than 50 centers open in the US, Canada, and Western Europe for FORWARD I patient enrollment.
• IMGN529 -- CD37-targeting ADC for diffuse-large B-cell lymphoma and potentially other non-Hodgkin lymphoma subtypes.
  • Advancing Phase 2 combination trial.
  • Potentially other program updates.
• Coltuximab ravtansine -- CD19-targeting ADC for DLBCL and potentially other NHL subtypes
  • Disclosure of combination regimen to be assessed in 1H2016.
  • Initiation of Phase 2 combination study midyear.
• IMGN779 -- Novel CD33-targeting ADC for acute myeloid leukemia and potentially other malignancies. IMGN779 is the first ADC utilizing one of ImmunoGen's new DNA-acting IGNs as the cancer-killing agent.
  • Initiation of Phase 1 testing for the treatment of AML in 1H2016.
    

3:32 am Qiagen sees FY15 EPS and revs below consensus (QGEN) :

• Co issues downside guidance for Q4 (Dec), sees EPS of $0.31-0.32 vs. $0.33 Capital IQ Consensus Estimate; sees Q4 (Dec) revs of $348 mln vs. $357.79 mln Capital IQ Consensus Estimate.
• Co issues downside guidance for FY15 (Dec), sees EPS of $1.05-1.06 vs. $1.08 Capital IQ Consensus Estimate; sees FY15 (Dec) revs of $1.28 bln vs. $1.29 bln Capital IQ Consensus Estimate.
• 2016 Outlook: "Our current expectations for 2016 are for approximately 6% adjusted net sales growth at constant exchange rates (:CER), and for adjusted earnings per share at
  CER to grow approximately in line with sales."
• Co's Commentary: "...Our anticipated results for the fourth quarter of 2015 are disappointing given the shortfall against our expectations for more improvements in adjusted net sales and adjusted earnings per share compared to the same period in 2014. This performance was hampered by factors that included volatility in the timing of revenues from the growing portfolio of companion diagnostic partnerships as well as lower revenues from instruments, even though we exceeded our target for new placements of QIAsymphony automation systems. Despite this setback, and due to the nature of these factors, QIAGEN continues to have a solid outlook for accelerating growth in 2016 based on the progress made on key initiatives during 2015."

3:23 am Emergent BioSolutions receives IRS ruling for the planned spin-off of its biosciences business (EBS) : Co's Commentary: "...Our next steps include selecting the Aptevo senior management team, filing with and obtaining clearance from the Securities and Exchange Commission of a Form 10 Registration Statement, and completing the distribution of Aptevo shares to our stockholders, which we expect to be completed by the middle of 2016."

3:21 am Cytokinetics presents analyses demonstrating predictive value of slow vital capacity for clinical outcomes in ALS (CYTK) :

Co announced the presentation of exploratory analyses of data from EMPOWER, a Phase 3 clinical trial of dexpramipexole in patients with ALS, which demonstrated the rate of decline of slow vital capacity predicts the risk of meaningful clinical events, including a decline in the three respiratory questions of the ALSFRS-R, as well as the time to the first occurrence of respiratory insufficiency, tracheostomy or death. Data from placebo-treated patients in EMPOWER were provided to Cytokinetics by Knopp Biosciences.

Key findings from the analyses of data from EMPOWER include:

• The overall slope of decline in percent predicted SVC from baseline through the follow-up period of 1.5 years was -0.090 percentage points per day (2.73 percentage points per month)
• Older subjects had a steeper slope of decline in SVC (-0.12 percentage points per day), as did subjects with baseline ALSFRS-R less than 39 (-0.10 percentage points per day).
• A slowing in the decline in SVC by 0.05 percentage points per day from baseline to the month 6 visit predicted reduction in risk by 19% of any decline in the respiratory subdomain of ALSFRS-R or death; by 22% for the first onset of respiratory insufficiency or death; by 23% for first occurrence of tracheostomy or death; and by 23% for death at any time after the month 6 visit
  

3:18 am AcelRx provides anticipated 2016 milestones; reports initiation and completion of final Phase 3 trial in the U.S. for Zalviso, NDA Resubmission (ACRX) :

Co announced anticipated 2016 milestones for its product portfolio, including ARX-04 (sufentanil sublingual tablet, 30 mcg) and Zalviso (sufentanil sublingual tablet system, 15 mcg). Specifically, AcelRx's corporate goals in the upcoming year are as follows:

• ARX-04 ER and Postoperative Study Completion. AcelRx has finalized the remaining clinical plans for ARX-04 for the treatment of moderate-to-severe acute pain in a medically supervised setting, following a recent pre-NDA meeting with the FDA. Enrollment in the current open-label study (SAP302) in the emergency room (:ER) will be continued, and a new study, known as SAP303, is expected to be initiated in the first quarter of 2016 in postoperative patients with moderate-to-severe acute pain. SAP303 will focus on enrolling patients older than 40 years of age and will allow for administration of ARX-04 for up to 12 hours. Both studies are expected to be completed in 2016. 
• ARX-04 NDA Submission. AcelRx intends to pursue an indication for ARX-04 of moderate-to-severe acute pain in a medically supervised setting. Assuming successful completion of the above studies, the company anticipates submitting the NDA for ARX-04 in the second half of 2016.
• Zalviso Open-Label Phase 3 Study Initiation and Completion. The company continues to advance the regulatory process for Zalviso and has completed a protocol review with the FDA. The Phase 3 study (IAP312) will primarily measure the rate of device errors, including the failure to dispense medication as well as the incidence of misplaced or dropped tablets. AcelRx expects to initiate the study in the first quarter of 2016.
• Zalviso NDA Submission. Pending timely completion of the IAP312 study, AcelRx expects to resubmit the NDA for Zalviso before the end of 2016.
• Zalviso EU Commercial Launch. In September 2015 the European Commission approved Zalviso for the management of acute moderate-to-severe post-operative pain in adult patients. The marketing authorization was granted for the 28 EU member states as well as for the European Economic Area countries, Norway, Iceland and Liechtenstein. Grunenthal Group, AcelRx's licensee in Europe, will be working with the member states of the EU and EEA to ensure that Zalviso is made available to those patients who would benefit from an effective and reliable solution for their acute moderate-to-severe post-surgical pain. The companies expect the product to be available to Western European patients in the first half of 2016

3:14 am Advanced Accelerator Applications reports Phase 3 NETTER-1 study met its primary endpoint by demonstrating that treatment with Lutathera (AAAP) :

Advanced Accelerator Applications S.A. (AAAP) announced that new safety and efficacy data from the pivotal Phase 3 NETTER-1 study investigating the treatment of Lutathera (177-Lu-Dotatate) in patients with inoperable, progressive, somatostatin receptor positive midgut neuroendocrine tumors.

• Lutathera's NETTER-1 study is the first Phase 3 international, multi-center, randomized, controlled trial evaluating 177Lu-DOTA0-Tyr3-Octreotate (Lutathera) in patients with inoperable, progressive, somatostatin receptor positive midgut NETs. 230 patients with Grade 1-2 metastatic midgut NETs (both functioning and not functioning) were randomized to receive Lutathera 7.4 GBq every 8 weeks (x4 administrations) versus Octreotide LAR 60 mg every 4-weeks. The primary endpoint was PFS per RECIST 1.1 criteria, with objective tumor assessment performed by an independent reading center every 12 weeks.
• Secondary objectives included objective response rate, overall survival, safety, and health-related quality of life.
• The Phase 3 NETTER-1 study met its primary endpoint by demonstrating that treatment with Lutathera was associated with a statistically significant and clinically meaningful risk reduction of 79% in disease progression or death versus a treatment with a double dose of Octreotide LAR.
• The median PFS in the Lutathera arm is not yet reached, whilst the median PFS in the Octreotide LAR 60 mg arm was 8.4 months.
  

3:10 am Vanguard Natural Resources commences private exchange offer of 7.875% Senior Notes due 2020 for a new issue of 7.0% Senior Secured Second Lien Notes due 2023 (VNR) :  

3:06 am Grupo Aeroportuario: Empresas ICA (ICA) unit and Banco Santander (SAN) unwind equity swap agreement 27.8 mln Series B shares in Grupo Aeroportuario del Centro Norte (OMAB) :

OMA (OMAB) informed that the trading volume of its shares on the Mexican Stock Exchange exceeded normal ranges today principally as the result of an operation carried out by Banco Santander (SAN, which exercised its right to sell 27,795,120 Series B shares of OMA, which represent 6.95% of the OMA's shares.

• These shares were involved in an equity swap agreement between Aeroinvest, S.A. de C.V (a subsidiary of Empresas ICA(ICA)) and Santander.
  

3:03 am William Lyon Homes commences $50 mln of 7.00% Senior Notes due 2022 (WLH) :