Why Opko Health Stock Is Off 23% Today
A rough day for the broad market is a downright terrible one for Opko Health (NASDAQ: OPK). Shares of the drug and diagnostics outfit were down by 23% as of 1:22 p.m. ET on Monday following Friday's post-close announcement that a growth-hormone deficiency treatment co-developed with Pfizer (NYSE: PFE) won't be approved by the Food and Drug Administration (FDA), at least not as requested in the initial New Drug Application.
The drug in question, somatrogon, aims to treat growth hormone deficiency in children. Pfizer and Opko have been working together on the treatment since 2014. Although approved in some overseas markets, the FDA has issued what is called a Complete Response Letter (CRL) regarding the drug's potential approval within the all-important U.S. market. While not an outright rejection of somatrogon, a CRL does indicate the regulator doesn't believe the treatment provides enough public benefit as tested, relative to the risk it might pose to patients.
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Source Fool.com
