FDA places clinical hold on Sarepta's LGMD gene therapy trials; revokes AAVrh74 platform designation

Sarepta Therapeutics, Inc.

FDA placed clinical hold on LGMD trials for SRP-9003, SRP-9004, SRP-6004, and SRP-9005.
Sarepta had paused most LGMD programs on July 16, 2025; SRP-9003 was excepted.
FDA revoked AAVrh74 platform technology designation previously granted on June 2, 2025.
Sarepta plans to discuss accelerated approval pathway for SRP-9003 after clinical hold lifted.
Enrollment and dosing in Phase 3 trial SRP-9003-301 was completed in December 2024.

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