After initially refusing to suspend Elevidys distribution after two deaths, Sarepta has now given in to the FDA’s request, noting the need to maintain a good working relationship with the regulator.

Sarepta Therapeutics ( NASDAQ: SRPT) faces an “arduous and treacherous path” to bring its gene therapy Elevidys back to market, according to a STAT report citing a senior FDA official, suggesting the treatment’s license could be revoked amid ongoing safety concerns.

The FDA has placed multiple investigational gene therapy clinical trials on hold, signaling broader platform concerns.

FDA places clinical hold on Sarepta's LGMD gene therapy trials after three deaths and revokes platform tech designation due to safety concerns.

The FDA will request Sarepta Therapeutics stop all shipments of Elevidys, its gene therapy for Duchenne muscular dystrophy, following two deaths tied to the product.

The 51-year-old patient who died had suffered from limb-girdle muscular dystrophy, a group of genetic disorders that cause muscles to weaken and atrophy. Sarepta said Friday that the death occurred in a Phase 1 clinical trial for an investigational gene therapy called SRP-9004,