FDA Advisory Committee Recommends Approval of Regeneron and Sanofi's Praluent® (alirocumab) Injection for Patients with Hypercholesterolemia
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Regeneron (REGN) PRALUEN Panel Commentary Could Result in Narrower-Than-Expected Labeling, BMO Capital Says
June 10, 2015 7:48 AM EDTBMO Capital analyst Jim Birchenough reiterated a Market Perform rating and $381 price target on Regeneron Pharma (NASDAQ: REGN) following yesterday's FDA panel review of PRALUEN.
Birchenough commented, "While the ultimate vote was positive and should support approval, we believe that panel member commentary could result in... More
Regeneron (REGN) Resumes Trading Up 1%
June 9, 2015 6:50 PM EDTRegeneron (NASDAQ: REGN) resumed trading up 1% after confirming FDA panel backing of Praluent injection.
... MoreRegeneron (REGN) to Resume Trading at 6:50PM ET
June 9, 2015 6:36 PM EDTRegeneron (NASDAQ: REGN) is set to resume trading at 6:50PM ET after confirming FDA panel backing of Praluent.
... MoreRegeneron (REGN) Confirms FDA Panel Backing of Praluent
June 9, 2015 6:34 PM EDTRegeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi (NYSE: SNY) confirmed that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the FDA recommended the approval of the investigational therapy Praluent® (alirocumab) Injection.
The Committee voted 13 to three (with no abstentions) that Regeneron and Sanofi had sufficiently established that the low-density lipoprotein cholesterol (LDL-C, or bad cholesterol) lowering benefit of Praluent exceeds its risks to support approval in one or more patient populations.
"We are pleased with the Committee's recommendation to approve Praluent. Our clinical trial program... More
