FDA Reverses Course, Allows Sarepta to Resume Duchenne Gene Therapy Shipments

The FDA initially requested Sarepta Therapeutics to pause distribution of its Duchenne muscular dystrophy gene therapy, Elevidys, following several patient deaths, including an 8-year-old boy on June 7, 202552.

Sarepta complied with the FDA’s request, halting shipments of Elevidys as of July 21, 20252.

After a rapid and comprehensive safety review, the FDA informed Sarepta on July 28, 2025, that it could resume shipments of Elevidys for ambulatory (walking) patients with Duchenne muscular dystrophy43.

Sarepta plans to immediately resume supplying Elevidys to treatment sites for ambulatory patients, while distribution for non-ambulatory patients remains paused pending further risk-mitigation discussions with the FDA4.

Both Sarepta and the FDA will continue updating Elevidys’s safety labeling and developing further risk-mitigation strategies for the non-ambulatory Duchenne population4.

Sources:

2. https://www.statnews.com/2025/07/21/sarepta-will-stop-shipping-elevidys-fda-duchenne-muscular-dystrophy/

3. https://www.fiercepharma.com/pharma/fda-takes-u-turn-sareptas-elevidys-backing-duchenne-gene-therapy-again-ambulatory-patients

4. https://www.stocktitan.net/news/SRPT/fda-informs-sarepta-that-it-recommends-that-sarepta-remove-its-pause-z09k4au8z1xd.html

5. https://www.fda.gov/news-events/press-announcements/fda-investigating-death-8-year-old-boy-who-received-elevidys