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November 18, 2015
07:43 EDTNVSJefferies to hold a conference
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07:02 EDTPFEMerck KGaA, Pfizer win FDA breakthrough therapy designation for Avelumab
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07:01 EDTMRKThreshold enters into definitive co-promotion agreement with Merck
Threshold Pharmaceuticals (THLD) announced that it finalized a definitive Co-Promotion Agreement for evofosfamide with Merck (MRK) pursuant to the companies' License and Co-Development Agreement entered into on February 2, 2012. Under the terms of the License and Co-Development Agreement, Threshold may co-promote evofosfamide in the U.S. subject to FDA approval of evofosfamide. Evofosfamide is Threshold's investigational hypoxia-activated prodrug, which is currently the subject of two fully enrolled Phase 3 clinical trials in advanced soft tissue sarcoma and advanced pancreatic cancer for which Threshold expects to announce top-line data around the end of 2015. Under the commercial leadership of Merck KGaA, Darmstadt, Germany, the terms of the License and Co-Development Agreement give Threshold the right, at its own cost, to field and be responsible for its own sales force in collaboration with Merck KGaA, Darmstadt, Germany's sales force in the U.S. pursuant to the terms of the new Co-promotion Agreement. Merck KGaA, Darmstadt, Germany remains responsible for all other commercial and medical affairs functions associated with the launch and promotion of evofosfamide. The development milestone payment and royalty payment portions of the License and Co-Commercialization Agreement remain the same. To date Threshold has received upfront and milestone payments of $110 million and can earn additional potential milestone payments of up to $440M.
06:09 EDTPFEValeant's Addyi sees hardly any sales, Bloomberg says
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November 17, 2015
16:38 EDTNVSAduro Biotech to delay filing 10-Q
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10:47 EDTBMYBristol-Myers strength attributed to sale chatter
The move higher in shares of Bristol-Myers (BMY) is being attributed by traders to chatter of a sale. The stock is up 2%, or $1.06, to $66.08 in morning trading. The unconfirmed talk has the company possibly approaching Gilead (GILD) about buyout interest. Bristol's market capitalization is just above $110B while Gilead's is just above $150B. Shares of Gilead are up 74c to $104.55.
10:00 EDTSHPGOn The Fly: Analyst Upgrade Summary
Today's noteworthy upgrades include: CF Industries (CF) upgraded to Positive at Susquehanna... ExlService (EXLS) upgraded to Buy from Neutral at BofA/Merrill... Fitbit (FIT) upgraded to Buy at BofA/Merrill... Forward Air (FWRD) upgraded to Outperform at Baird... HD Supply (HDS) upgraded to Positive from Neutral at Susquehanna... Hannover Re (HVRRY) upgraded to Overweight from Underweight at JPMorgan... Moody's (MCO) upgraded to Buy from Neutral at UBS... PRA Group (PRAA) upgraded to Strong Buy from Market Perform at Raymond James... Plum Creek Timber (PCL) upgraded to Outperform from Sector Perform at RBC Capital... Shire (SHPG) upgraded to Outperform from Market Perform at Leerink... Yandex (YNDX) upgraded to Overweight from Equal Weight at Morgan Stanley... Zayo Group (ZAYO) upgraded to Buy from Neutral at MoffettNathanson.
08:22 EDTCELGSignificant Celgene overhang removed, says JMP Securities
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08:04 EDTMRKMerck to present new KEYTRUDA findings at upcoming congresses
Merck announced that data investigating the use of KEYTRUDA, the company's anti-PD-1 therapy, in advanced non-small cell lung cancer, melanoma, classical Hodgkin lymphoma, multiple myeloma, and ER-positive/HER2-negative breast cancer will be presented at four medical congresses through the end of this year. In total, data from more than 30 abstracts will be presented at the Society for Melanoma Research 2015 Congress in San Francisco, Nov. 18 - 21; the 57th American Society of Hematology Annual Meeting in Orlando, Florida, Dec. 5 - 8; the San Antonio Breast Cancer Symposium, Dec. 8 - 12; and the European Society for Medical Oncology Asia 2015 Congress in Singapore, Dec. 18 - 21. By the end of 2015, data on the anti-tumor activity of KEYTRUDA will have been presented across more than 20 tumor types. "The field of immuno-oncology holds great potential across a broad spectrum of cancers," said Dr. Roy Baynes, senior vice president and head of global clinical development, Merck Research Laboratories. "Data for KEYTRUDA being presented at these scientific meetings include a first-time comparison to chemotherapy in advanced non-small cell lung cancer, novel combination data in advanced melanoma as well as first-time data in two additional tumor types, namely multiple myeloma and hormone receptor positive breast cancer, further demonstrating our deep commitment to advancing cancer treatment."
07:34 EDTNVSOphthotech to hold a conference call
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06:08 EDTNVSRoche subsidiary to participate in Ophthotech and Novartis agreement
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05:24 EDTNVSNovartis announces Phase III FLAME head-to-head trial met primary endpoint
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05:22 EDTPFEStocks with implied volatility movement; P PFE
Stocks with implied volatility movement; Pandora (P) 104, Pfizer (PFE) 29 according to iVolatility.
November 16, 2015
17:05 EDTBMYBristol-Myers announces FDA accepts for priority review sBLA for Opdivo
Bristol-Myers Squibb Company announced that the U.S. FDA has accepted for filing and priority review a supplemental Biologics License Application for Opdivo for the treatment of patients with advanced renal cell carcinoma who have received prior anti-angiogenic therapy. The FDA previously granted Opdivo Breakthrough Therapy Designation for this indication, underscoring the critical need for new treatment options for patients with advanced RCC who have received prior therapy. The projected FDA action date is March 16, 2016.
16:53 EDTSHPGPaulson reduced stake in Valeant
Paulson & Co. gave a quarterly update on its stakes in a filing this afternoon. NEW STAKES: Perrigo (PRGO), CIT Group (CIT), Precision Castparts (PCP), Cameron (CAM), and Altera (ALTR). INCREASED STAKES: Teva (TEVA), Post Holdings (POST), Starwood Hotels (HOT), LivaNova (LIVN), and Synergy Pharmaceuticals (SGYP). DECREASED STAKES: Valeant (VRX), Shire (SHPG), Whiting Petroleum (WLL), Computer Sciences (CSC), and Oasis Petroleum (OAS). LIQUIDATED STAKES: Houghton Mifflin Harcourt (HMHC), Broadcom (BRCM), and Sprint (S).
16:18 EDTSHPGShire upgraded to Outperform, price target raised to $239 at Leerink
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16:02 EDTSHPGShire upgraded to Outperform from Market Perform at Leerink
14:38 EDTJNJGenmab confirms FDA approval of Darzalex
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13:32 EDTPFECantor helps Moelis clinches advisory role for Pfizer, Reuters reports
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13:11 EDTCELGCelgene jumps 2% after defeating Kyle Bass patent challenge
Shares of Celgene moved higher after the U.S. Patent and Trademark Office declined to review a Revlimid patent expiring in 2019. The USPTO found that that Bass's Coalition for Affordable Drugs was unlikely to succeed, according to Bloomberg. Shares of Celgene are up 2%, or $1.64, to $190.13 in afternoon trading. The agency is reviewing two other patents on the drug.
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