Regeneron (REGN) PRALUEN Panel Commentary Could Result in Narrower-Than-Expected Labeling, BMO Capital Says

AdCom Approval, Reservations on Praluent Largely Inline with Expectations; Roth Affirms Regeneron (REGN) at 'Neutral'

Roth capital affirms Regeneron Pharmaceuticals (Nasdaq: REGN) with a Neutral rating and $495 price target after the company confirmed that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the FDA recommended the approval of the investigational therapy Praluent (alirocumab) Injection.

Analyst Joseph Pantginis commented, The vote to approve Praluent is in line with our expectations as were their... More

RBC Capital Comments on Regeneron (REGN) Following 'Unexpectedly Cautious' Adcom

RBC Capital maintained an Outperform rating on Regeneron Pharma (NASDAQ: REGN) with a price target of $543. Yesterday an FDA panel recommended the approval of Regeneron and Sanofi's (NYSE: SNY) investigational therapy Praluent. Despite the favorable recommendation, analyst Adnan Butt described the panel as "unexpectedly cautious," though he still expects a broad, if not the broadest, label.

"Despite the overall recommendation for approval, the panels caution around breadth of label, safety, and outcomes can create an overhang. We... More

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) and Sanofi's (SNY) Praluent Wins FDA Panel Backing - Bloomberg

Regeneron (NASDAQ: REGN) and Sanofi (NYSE: SNY) PCSK9 (proprotein convertase subtilisin/kexin type 9) drug, Praluent, wins FDA panel backing, according to Bloomberg.