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FDA takes U-turn on Sarepta’s Elevidys, backing Duchenne gene therapy again in ambulatory patients
On Monday, the FDA said Sarepta may resume treating ambulatory Duchenne patients with Elevidys. The recommendation comes just 10 days after the agency requested that the company halt all shipments of the one-time treatment following reports of three deaths among patients who had received a Sarepta gene therapy, including two on Elevidys.
The European Union’s health regulatory agency did not endorse approving Elevidys for ambulatory patients with Duchenne ...
The European Medicines Agency’s drug advisory committee (CHMP) rejected Elevidys for children aged 3 to 7 years who are able ...
A second patient has died following treatment with Sarepta Therapeutics’ Elevidys, raising more doubts about the Duchenne muscular dystrophy (DMD) gene therapy’s safety profile. Sarepta and ...
Shares of Sarepta Therapeutics closed down as much as 42% to hit a nine-year low of $18.30 on Monday after a second death of a male teenage patient who had received its gene therapy, Elevidys ...
FDA confirms two fatal cases of liver failure in DMD patients treated with Elevidys HC Wainwright reiterates Sell rating on Sarepta, with a $10 price target The market’s back, and these 3 income ...
Sarepta Therapeutics shares sank to their lowest level in nine years Monday after a second patient taking its Elevidys drug died. The patient was being treated for Duchenne muscular dystrophy, and ...
June 15 (Reuters) - Sarepta Therapeutics (SRPT.O), opens new tab on Sunday said there had been a second reported case of acute liver failure resulting in death after a patient received the company ...
Sarepta Therapeutics, Inc. stock fell after an ELEVIDYS-related death. However, click for why strong SRTP revenue growth and reset expectations lead to a Buy rating.
A recent FDA investigation has paused further distribution of Elevidys, following reports of at least three patient deaths.
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