UPDATE: Amgen Inc. Stock Drops 2% On Drug's Cardiovascular Risk; No Approval Expected This Year

Amgen Inc. shares dropped 1.9% in morning trade Monday after the company said that it has observed new cardiovascular risks for its Evenity drug, which is intended to reduce risk of fractures in patients with osteoporosis, and that it does not expect the drug to get approved this year. Shares of its partner on the drug, UCB , declined 17.9%. Amgen said it saw this new cardiovascular safety signal in its late-stage trial for the drug, with Evenity having an imbalance in serious cardiovascular adverse events as compared with the current standard of care in osteoporosis, alendronate. Sean Harper, Amgen's executive vice president of research and development, said that "the newly observed cardiovascular safety signal will have to be assessed as part of the overall benefit:risk profile for Evenity" and that it would work with UCB to evaluate the data with global regulators and medical experts. The latest results are "clearly negative, and very surprising," said EvercoreISI analyst Umer Raffat. The clinical trial met its two primary endpoints and its key secondary endpoint, Amgen also said. Amgen shares have dropped 11.1% over the last three months, and UCB shares have declined 8.2%, compared with a 1.1% rise in the S&P 500 .

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