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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.
Stock of Sarepta Therapeutics Inc. (NASDAQ: SRPT) surged 38.89% in Tuesday pre-market following the U.S. Food and Drug ...
The European Medicines Agency determined testing failed to prove Elevidys’ benefit and issued a negative opinion that could ...
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