ELEVIDYS
delandistrogene moxeparvovecgene therapyAAVrh74-microdystrophin transfer
Duchenne Muscular Dystrophy
Approved
1 program·1 trial·View drug →
Upcoming catalysts2
AdComMAY 222026·22 daysEXACT
ELEVIDYS sBLA Cellular, Tissue, and Gene Therapies AdCom
FDA outside-expert panel reviews evidence to expand ELEVIDYS into a broader Duchenne population. The vote is non-binding; FDA has historically aligned with AdCom recommendations ~75% of the time on biologics. Output: vote tally, panel concerns flagged on the public record.
Cited“The Cellular, Tissue, and Gene Therapies Advisory Committee will meet on May 22, 2026, to review BLA STN125781 (delandistrogene moxeparvovec — ELEVIDYS) Supplemental.”
Advisory Committee·FDA·disclosed 1mo ago
PDUFAJUL 302026·3 monthsEXACT
ELEVIDYS sBLA PDUFA Decision
FDA decision deadline on extending ELEVIDYS to ambulatory DMD patients aged ≥4. Three possible outcomes: approval, Complete Response Letter (CRL), or PDUFA extension. ELEVIDYS is currently Sarepta’s primary commercial product.
Cited“The FDA has set a PDUFA action date of July 30, 2026 for the supplemental Biologics License Application for ELEVIDYS expanding to ambulatory patients ≥4 years.”
PDUFA Decision·PR·disclosed 3mo ago