News

Sarepta Needs to Show FDA Elevidys Won’t Cause More Deaths
The Food and Drug Administration won’t sign off on Sarepta Therapeutics Inc. bringing its controversial gene therapy back to ...
InnovationRx: Sarepta Blinks In Showdown With FDA
In this week’s edition of InnovationRx, we look at Moderna’s use of quantum computers, a new top drug regulator at the FDA, ...
Sarepta stock faces multiple downgrades and questions of solvency amid Elevidys pause
For Sarepta, the hits keep coming, with several downgrades in the past week after it was forced to temporarily take its top-selling drug off the market.
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Following Sarepta’s Lead, Roche Suspends Elevidys Shipments to Some Ex-US Countries
Discovered and developed by Sarepta Therapeutics, Elevidys is a gene therapy that won accelerated approval in June 2023 and ...
Sarepta Therapeutics crisis is huge blow to Duchenne families, company
Sarepta rebuffed a call from the Food and Drug Administration to halt all shipments of its gene therapy for Duchenne muscular ...
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Roche halts Elevidys distribution in some countries, following Sarepta's lead in US
Roche is pausing shipments of Elevidys in some countries, following partner Sarepta Therapeutics’ move in the U.S., as safety ...
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Sarepta’s Wild Week, CDER’s New Leader, FDA Rejections, Manufacturing Billions
Sarepta Therapeutics faces serious FDA action after news broke of a third patient death, the FDA gets a new top drug ...
Sarepta cut to Underperform at BofA on Elevidys concerns
Bank of America downgraded Sarepta Therapeutics (NASDAQ:SRPT) to Underperform from Neutral on Wednesday, becoming the latest brokerage to issue a bearish view on the company, citing safety concerns ...