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Companies with PCSK9 inhibitors fall on FDA concerns

March 8, 2014 12:43 AM UTC

Several companies developing proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors fell on Friday on Twitter reaction to FDA concerns about neurocognitive adverse events for the class. The agency's concerns were disclosed in SEC filings from both Sanofi (Euronext:SAN; NYSE:SNY) and Regeneron Pharmaceuticals Inc. (NASDAQ:REGN), which are partnered for anti-PCSK9 mAb alirocumab ( REGN727). FDA declined to provide details, including the compound or compounds that triggered the agency's concern and whether the events occurred for anti-PCSK9 monotherapy or in combination with statins. The labels for statins contain warning language about the risk of neurocognitive adverse events.

Sanofi said the partners are not aware of a neurocognitive signal for alirocumab, which is in the Phase III ODYSSEY program. Regulatory applications are slated for next year. Regeneron was off $10.34 to $328.11 on Friday, but ended the week off $4.39. ...