Quick FDA approval for Opdivo in NSCLC
Bristol-Myers Squibb Co. (NYSE:BMY) jumped $3.75 to $65.67 on Tuesday after FDA approved an sBLA for Opdivo nivolumab to treat patients with metastatic squamous non-small cell lung cancer (NSCLC) who have progressed on or after platinum-based chemotherapy. The approval came more than three months ahead of the drug's June 22 PDUFA date, and just five days after BMS said FDA accepted the sBLA for review.
Pharmacyclics surges on report of J&J deal
Pharmacyclics Inc. (NASDAQ:PCYC) jumped $6.72 to $237.20 in after-hours trading on Wednesday as rumors intensified that Johnson & Johnson (NYSE:JNJ) has agreed to buy the cancer drug developer.
Bavarian Nordic gains on BMS option deal
Bavarian Nordic A/S (CSE:BAVA) gained DKK74.50 (35%) to DKK286 after granting Bristol-Myers Squibb Co. (NYSE:BMY) an exclusive option to license and commercialize Prostvac. The deal, which includes $60 million up front and more than $915 million in milestones, is the largest reported option agreement for a Phase III compound.
Grifols partners with Alkahest, takes equity stake
Grifols S.A. (Madrid:GRF; NASDAQ:GRFS) and Alkahest Inc. will collaborate to develop plasma-based therapies to treat cognitive decline in aging and CNS disorders.
Takeda promotes Weber to CEO
Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) promoted President and COO Christophe Weber to CEO, effective April 1. Weber, who succeeds Yasuchika Hasegawa, will retain the title of president and the COO position will be eliminated. Hasegawa will remain chairman.
Baxter acquires autoimmune play SuppreMol
Baxter International Inc. (NYSE:BAX) acquired SuppreMol GmbH (Martinsried, Germany) for EUR 200 million ($223.9 million).
Antibody developer Xoma Corp. (NASDAQ:XOMA) promoted Thomas Burns to CFO from VP of finance. Burnes succeeds Fred Kurland, who plans to retire on April 3.
Orexigen holds gains on CV outcomes data
Orexigen Therapeutics Inc. (NASDAQ:OREX) climbed $0.84 (11%) to $8.48 on Wednesday, adding $103.9 million in market cap, as investors overlooked controversy about how interim data were disclosed from the LIGHT cardiovascular outcomes trial of its marketed Contrave naltrexone/bupropion. With more data not expected to be disclosed before 2017, or even later, the market apparently concluded the statistically significant data showing Contrave is the first obesity drug to show a CV benefit will be sufficient to drive the drug's uptake by doctors and patients even without a label change.
Tricida raises $30M series B
Renal company Tricida Inc. (South San Francisco, Calif.) raised a $30 million series B round led by existing investor OrbiMed. Existing investors Sibling Capital Ventures and Limulus Venture Partners also participated.
Tesaro raises $173.4M in follow-on
Tesaro Inc. (NASDAQ:TSRO) raised $173.4 million through the sale of 3.4 million shares at $51 in a follow-on underwritten by Citigroup; Leerink; Deutsche Bank; BMO Capital Markets; Baird; and Mizuho. Tesaro proposed the offering after market close on Monday when its shares were valued at $54.25. The company shed $0.64 to $51.73 on Wednesday.
POLITICS & POLICY
NCI's Varmus to step down
Harold Varmus said he will step down as director of NIH's National Cancer Institute, effective March 31. Varmus, who has held the position since 2010, intends to establish a research laboratory at Weill-Cornell Medical College.
FDA to discuss clinical outcomes assessments
FDA will hold a public workshop on April 1 to discuss the development and implementation of clinical outcomes assessments (COAs). Topics will include ways to include patient-centered outcome measures in drug development, standards for use of COAs in drug development, and standards for collaborative development and dissemination of COAs.