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Exclusive: Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys
U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a muscular dystrophy patient who received a different, experimental treatment died,
FDA investigating deaths linked to Sarepta’s AAVrh74 gene therapies
As of July 18, 2025, the Food and Drug Administration (FDA) said it has received three reports of fatal acute liver failure following treatment of patients with Sarepta Therapeutics’ AAVrh74 gene therapies that appear to have been caused by the gene therapy products as a result of acute liver failure.
Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.
The FDA will request Sarepta Therapeutics stop all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, ...
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