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FDA takes U-turn on Sarepta's Elevidys, backing Duchenne gene therapy again in ambulatory patients
Monday, the FDA said Sarepta may resume treating ambulatory DMD 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 ...
Sarepta Therapeutics Inc. (NASDAQ:SRPT) stock declined 13% Friday after European regulators recommended against approving Elevidys, the company’s gene therapy for Duchenne muscular dystrophy.
European regulators on Friday said that the Duchenne muscular dystrophy gene therapy Elevidys should not be approved ...
Despite a new setback for Elevidys in Europe, Roche—which markets Sarepta’s gene therapy outside the U.S.—remains committed ...
FDA evaluating further regulatory actions after deaths Elevidys is the only gene therapy for Duchenne muscular dystrophy Sarepta suggested updating Elevidys' label June 24 (Reuters) - The U.S ...
Sarepta Therapeutics (NASDAQ: SRPT) fell ~38% in the premarket on Monday after the company reported a second fatality from acute liver failure in a patient treated with Elevidys, a gene therapy ...
The death of a second teenage boy from liver failure caused by a gene therapy from Sarepta Therapeutics has left the Duchenne muscular dystrophy community angry, fearful, and divided over whether ...
Nevertheless, on the same day, Sarepta assured investors that “the benefit-risk of ELEVIDYS remains positive.” Next, on June 15, 2025, Sarepta announced that a second patient treated with ...
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