The Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the FDA recommended the approval of the Praluent Injection after the bell Tuesday. The Committee voted 13 to three that Regeneron Pharmaceuticals Inc. (REGN) and Sanofi had sufficiently established that the low-density lipoprotein cholesterol lowering benefit of Praluent exceeds its risks to support approval in one or more patient populations.
Regeneron Pharmaceuticals has gapped open sharply lower Wednesday morning and is now down 22.40 at $503.69. The stock pulled back from the highs of the year at the start of the trading week and has set a 2-week low.
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