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

Sarepta Therapeutics (SRPT) shares fell as much as 4.8% in premarket trading Monday, poised to extend losses for a second ...

Sarepta Therapeutics traded lower on Monday, extending a slide as the company took the unusual step of refusing a Food and ...

Sarepta stock tanked Friday after a new patient death was uncovered, spurring an FDA request to halt shipments of an ...

U.S. regulators recently asked Sarepta Therapeutics to voluntarily halt shipments of its Elevidys gene therapy after a ...

As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head, the biotech is standing firm ...

Sarepta Therapeutics faces challenges as the FDA halts gene therapy trials for LGMD and revokes AAVrh74 platform designation.

The crisis over Sarepta Therapeutics' Duchenne therapy offers a valuable lesson: Listening to critics, and responding with ...

Children's Hospital Los Angeles, citing recent U.S. Food and Drug Administration actions, on Monday said it has paused usage of Sarepta Therapeutics' gene therapy Elevidys in all patients with ...

The agency also revoked Sarepta's platform technology designation for AAVrh74 Friday and issued a safety communication saying ...

The company refused the FDA’s request and will continue shipping its therapy, Elevidys, to Duchenne patients who can still ...

Children’s Hospital Los Angeles paused Sarepta’s Elevidys gene therapy after FDA flagged safety issues, including deaths in ...