08:25 AM EDT, 07/21/2025 (MT Newswires) -- Sarepta Therapeutics ( SRPT ) said Monday in a regulatory filing the US Food and Drug Administration has placed a clinical hold on its gene therapy trials for limb-girdle muscular dystrophy.

The hold includes the company's LGMD clinical trials related to its therapeutic candidates SRP-9003, SRP-9004, SRP-6004, and SRP-9005, the company said.

Sarepta said it intends to seek discussions with the FDA for a potential pathway to submit a Biologics License Application seeking accelerated approval for SRP-9003 after the clinical hold is lifted.

Sarepta added that the FDA has revoked the platform technology designation for the company's AAVrh74 platform technology, previously granted on June 2.

Late Friday, the company noted the FDA had ask it to voluntarily halt shipments of its Elevidys drug therapy for Duchenne muscular dystrophy in the US. The company said it intended to continue shipments of the therapy drug to the ambulant population.

Shares of Sarepta were recently down 8.5% in recent Monday premarket activity.