US Food and Drug Administration Commissioner Marty Makary said he’s “taking a hard look” at whether a gene therapy from Sarepta Therapeutics Inc. should remain on the market.

The growing number of fatalities is raising questions about the future of Sarepta’s therapies and the regulatory path for gene treatments that use adeno-associated viral (AAV) vectors. Elevidys, which was granted accelerated approval in 2023 for Duchenne muscular dystrophy, has remained on the market under post-approval study requirements.

The U.S. Food and Drug Administration is planning to request Sarepta Therapeutics to voluntarily stop all shipments of its gene therapy, Elevidys, a source familiar with the matter told Reuters on Friday.