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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.
FDA Probes Death Of 8-Year-Old Who Received Sarepta's Elevidys
The U.S. Food and Drug Administration (FDA) announced on Friday, after market close, that it is investigating the death of an 8-year-old boy who had received Elevidys, Sarepta Therapeutics Inc.’s (NASDAQ:SRPT) gene therapy for Duchenne muscular dystrophy.
Sarepta Therapeutics (NASDAQ:SRPT) shares dropped sharply premarket on Monday before paring losses as Barclays revised its ...
In its own communique issued shortly after the FDA’s, Sarepta elaborated on the situation and confirmed a Roche statement to ...
The European Medicines Agency determined testing failed to prove Elevidys’ benefit and issued a negative opinion that could ...
Sarepta Therapeutics (NASDAQ:SRPT) resumed its recent sell-off on Thursday after Endpoints News reported that the FDA would ...
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