Dyne Therapeutics submits FDA application for DMD treatment
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Dyne Therapeutics Announces Submission of Biologics License Application (BLA) to U.S. FDA for Z-Rostudirsen in Exon 51 Duchenne Muscular Dystrophy (DMD)
May 26, 2026 7:30 AM EDT- Submission for Accelerated Approval based on dystrophin as a surrogate endpoint -
- In the registrational expansion cohort of the DELIVER trial, treatment with z-rostudirsen resulted in a robust and statistically significant increase in dystrophin production with functional improvement observed across multiple clinical endpoints and a favorable safety profile1 -
- Proposed dosing regimen of 20 mg/kg administered intravenously once every 4 weeks (Q4W) -
WALTHAM, Mass., May 26, 2026 (GLOBE NEWSWIRE) --... More
