What was the July 2025 confrontation between Sarepta and the FDA?
On July 18, 2025 the FDA asked Sarepta to pause all Elevidys shipments — Sarepta initially refused, then reversed days later — while also confirming a third death it had reported to the FDA two weeks earlier but not disclosed publicly.
On July 18, 2025, the FDA announced clinical holds on Sarepta's limb-girdle gene therapy trials, revoked the AAVrh74 platform technology designation, and asked Sarepta to stop shipping Elevidys. Sarepta initially said it would not comply, then reversed days later. BioPharma Dive described it as a highly unusual standoff. Transparency was a major issue: Sarepta had reported the third death to the FDA on July 3 but not to the public, disclosing it only after the fact, and analysts questioned why it had gone unmentioned on a recent investor call. CEO Doug Ingram said pausing was painful but necessary. The FDA's biologics chief, Vinay Prasad, said the agency would not allow products whose harms are greater than benefits.