Sarepta Will Not Resume Elevidys ENVISION Enrollment as DMD Rivals Close In
- Sarepta will not restart enrollment in ENVISION, the confirmatory study of Elevidys in non-ambulatory and older patients, which was paused last summer with about half of its target enrolled.
- It plans to give the FDA 12-week safety data from a sirolimus cohort of ENDEAVOR in Q1 2027 and is working to restore the non-ambulatory label. Q3 Elevidys sales fell year on year but beat one analyst's estimate.
💡 Points Based on public reports
Stopping a half-enrolled confirmatory trial leaves the older-patient story resting on a label-restoration negotiation rather than randomized evidence. Dyne's exon-51 decision in January and REGENXBIO's planned 2027 filing mean Sarepta's window to stabilize sales before share erosion is roughly a year; the sirolimus safety data is the near-term catalyst to watch.
Sarepta’s new CEO confident in clinical execution as DMD competitors close in ↗