FDA accepts Dyne Therapeutics BLA for DMD drug z-rostudirsen
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Dyne Therapeutics Announces U.S. FDA Acceptance of Biologics License Application (BLA) for Z-Rostudirsen in Exon 51 Duchenne Muscular Dystrophy (DMD)
July 20, 2026 7:30 AM EDT- Priority Review granted; PDUFA target action date set for January 21, 2027 -
- Submission for Accelerated Approval based on dystrophin as a surrogate endpoint -
- In the registrational expansion cohort of the DELIVER trial, treatment with z-rostudirsen once every 4 weeks resulted in a robust and statistically significant increase in dystrophin production with functional improvement observed across multiple clinical endpoints and a favorable safety profile1Â -
WALTHAM, Mass., July 20, 2026 (GLOBE NEWSWIRE) --... More
