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# Elevidys Shipping Nixed After 2nd Liver‑Failure Death
- URL: https://www.fdaweb.com/elevidys-shipping-nixed-after-2nd-liver-failure-death/
- Published: 2025-06-17T12:00:00.000Z
- Updated: 2026-09-14T15:14:28.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159373

Sarepta Therapeutics says it has stopped shipping its gene therapy Elevidys (delandistrogene moxeparvovec‑rokl) to non‑ambulatory Duchenne muscular dystrophy (DMD) patients and paused dosing in a key confirmatory trial after a second recipient died from acute liver failure. Both fatal cases involved non‑ambulatory individuals with DMD, the company says.

The latest death was disclosed 6/15 and follows the March death of a 16‑year‑old boy who also developed acute liver failure months after treatment. To reduce risk, Sarepta says it is convening an independent panel of neuromuscular and hepatology specialists to review an “enhanced” immunosuppression plan that adds the mTOR inhibitor sirolimus to the current steroid regimen. Shipments for non‑ambulatory patients will remain on hold until FDA signs off, and dosing in the confirmatory Phase 3 ENVISION trial (SRP‑9001‑303) is suspended pending a protocol amendment.

Sarepta says more than 900 patients worldwide have received Elevidys, a $3.2 million one-time infusion that delivers a shortened dystrophin gene via an adeno‑associated viral vector.