Dyne Therapeutics, Inc. (DYN) on Monday reported positive topline results from the Registrational Expansion Cohort (REC) of its Phase 1/2 DELIVER trial of zeleciment rostudirsen (z-rostudirsen) in patients with Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. The company also released new long-term data from the trial's open-label extension and long-term extension phases.
The REC achieved its primary endpoint, showing a statistically significant increase in muscle content-adjusted dystrophin expression to 5.46% of normal at six months. Dyne said functional improvements were observed across multiple measures at six months, and lung function was maintained. Long-term data showed sustained functional benefit across all assessed endpoints through 24 months.
Dyne said it plans to submit a Biologics License Application for Z-Rostudirsen for U.S. accelerated approval in the second quarter of 2026 and will launch a global Phase 3 study of z-rostudirsen in the same period. Assuming priority review, the company expects a potential U.S. launch in the first quarter of 2027.
Dyne Therapeutics shares closed Friday's trading at $20.28, up 1.79%.
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