USFDAJul 20, 2026, 07:41 AM
Dyne Therapeutics BLA for Zeleciment Rostudirsen Accepted by FDA
AI Summary
Dyne Therapeutics, Inc. announced that the U.S. Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for zeleciment rostudirsen (DYNE-251) for Duchenne muscular dystrophy. The FDA granted Priority Review and set a PDUFA target action date of January 21, 2027. The company continues to expect a potential U.S. launch in the first quarter of 2027, contingent on approval.
Key Highlights
- FDA accepted Biologics License Application (BLA) for zeleciment rostudirsen (DYNE-251).
- Drug is for Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping.
- FDA granted Priority Review for the BLA.
- Prescription Drug User Fee Act (PDUFA) target action date is January 21, 2027.
- Company anticipates potential U.S. launch in Q1 2027, assuming approval.
Price Impact
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