Regeneron (REGN) Halted Ahead of FDA Panel Review of Praluent

Regeneron (REGN) Resumes Trading Up 1%

Regeneron (NASDAQ: REGN) resumed trading up 1% after confirming FDA panel backing of Praluent injection.

Regeneron (REGN) to Resume Trading at 6:50PM ET

Regeneron (NASDAQ: REGN) is set to resume trading at 6:50PM ET after confirming FDA panel backing of Praluent.

Regeneron (REGN) Confirms FDA Panel Backing of Praluent

Regeneron 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

Regeneron (REGN) PRALUENT Briefing Docs Positive But Risk to Labeling for Statin Intolerance, BMO Capital Says

BMO Capital analyst Jim Birchenough reiterated his Market Perform rating and $381 price target on Regeneron Pharma (NASDAQ: REGN) following briefing document last Friday for the June 9 Advisory Committee meeting on REGN/Sanofi's PRALUENT. Birchenough said while the document appears to be highly positive on PRALUENTs efficacy in LDL-C lowering and safety profile, the analyst notes risk to labeling for statin... More

FDA Breifing Documents for Regeneron's (REGN) Praluent 'Read Well,' Says RBC Capital

RBC Capital maintained an Outperform on Regeneron Pharma (NASDAQ: REGN). Earlier the FDA posted briefing docs for Regeneron (NASDAQ: REGN) and Sanofi's (NYSE: SNY) PCSK-9 drug Praluent. In the view of analyst Adnan Butt, FDA documents "read well."

"Overall conclusions... More