BioCentury
ARTICLE | Clinical News

CV signal in osteoporosis trial sinks UCB, Amgen shares

May 22, 2017 11:09 PM UTC

Amgen Inc. (NASDAQ:AMGN) and UCB S.A. (Euronext:UCB) no longer expect FDA to approve Evenity romosozumab this year after new data from the Phase III ARCH trial revealed a previously unseen cardiovascular safety signal in postmenopausal women with osteoporosis at high risk of fracture.

While the companies said the compound met both of the study's primary endpoints, the companies said there was an imbalance in positively adjudicated CV serious adverse events. Evenity is under FDA review to treat osteoporosis, with a PDUFA date of July 19...

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