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.

Sarepta Therapeutics (NASDAQ:SRPT) shares dropped to a new 52-week low on Friday, triggering a trading halt after Bloomberg News reported that the FDA is reviewing whether the company’s gene therapy Elevidys,