What was the standoff between Sarepta and the FDA?
On July 18, 2025, the FDA informally 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 informally asked Sarepta to pause all Elevidys shipments. Sarepta initially said it would not comply, before reversing its position several days later. As BioPharma Dive reported, this was a highly unusual public confrontation between a company and its regulator. Compounding it, Sarepta had reported the third death to the FDA on July 3 but did not disclose it publicly, confirming it only hurriedly later; analysts questioned why it had not been mentioned on a conference call held days earlier.
CEO Doug Ingram called the decision to pause painful but necessary to preserve a productive relationship with the agency. The FDA's biologics chief, Vinay Prasad, said the agency would not allow products whose harms are greater than benefits.