Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys

Sarepta to pause gene therapy Elevidys shipments in U.S.

Sarepta said on Monday it will pause all shipments of Elevidys in the United States after two teenage boys, who had received the gene therapy, died this year.

Sarepta Therapeutics Announces Voluntary Pause of ELEVIDYS Shipments in the U.S.

CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jul 21, 2025-

The crisis over Sarepta’s Duchenne therapy is a mess. But the lesson is clear

No matter how the situation between the company and the FDA is resolved, this is no way to do drug development.

Sarepta slips further after it says it will keep selling gene therapy despite FDA’s request to pull it

The drug, Elevidys, accounts for about half of Sarepta’s revenue....

Sarepta Faces Regulatory Showdown As Analysts Cut Price Targets - Sarepta Therapeutics (NASDAQ:SRPT)

On Friday, the U.S. Food and Drug Administration placed Sarepta Therapeutics Inc.’s (NASDAQ:SRPT) investigational gene therapy clinical trials for limb girdle muscular dystrophy (LGMD) on a clinical hold. The decision stemmed from serious safety concerns, including three patient deaths potentially linked to these products, indicating that study participants faced or would be exposed to an unreasonable and significant risk of illness or injury. T…

Drugmaker Refuses FDA's Request to Pull Gene Therapy Tied to Patient Deaths

(MedPage Today) -- Sarepta Therapeutics will continue to ship its gene therapy delandistrogene moxeparvovec (Elevidys) to ambulant patients with Duchenne muscular dystrophy, despite the FDA's request to halt distribution, the company stated late...