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Actionable news in BMY: BRISTOL-MYERS SQUIBB CO.,

Portola PTLA PDUFA date for AndexXa set for February 2, 2018; Bristol-Myers BMY misses key endpoint

Price and Volume Movers

Bristol-Myers Squibb Company (NYSE: BMY) announced top-line data after-hours from the CheckMate-214 trial of Opdivo (nivolumab) in combination with Yervoy (ipilimumab) versus sunitinib in patients with metastatic renal cell carcinoma. The combination met the co-primary endpoint of objective response rate (ORR) and achieved a 41.6% ORR versus 26.5% for sunitinib. However, its key other co-primary endpoint of progression-free survival (PFS) which registered 11.56 months for the Opdivo and Yervoy combo versus 8.38 months for sunitinib was not statistically significant. Shares are currently down 2.4% in the after-hours session to $56.45.

Portola Pharmaceuticals Inc.(Nasdaq:PTLA) announced that the FDA set a PDUFA date of February 2, 2018 for the resubmission of its Biologics License Application (BLA) for AndexXa (andexanet alfa). The company was issued a Complete Response Letter (CRL) by the FDA in...