Dyne Therapeutics Announces Submission of Biologics License Application (BLA) to U.S. FDA for Z-Rostudirsen in Exon 51 Duchenne Muscular Dystrophy (DMD)

- 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 NEWSW