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Dyne Therapeutics Initiates Phase 3 FORZETTO Trial Of Zeleciment Rostudirsen In Individuals With Duchenne Muscular Dystrophy Amenable To Exon 51 Skipping

Benzinga·05/20/2026 11:49:24
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- 72-week trial will enroll approximately 90 participants; first site now open for enrollment -

- Primary endpoint is rise from floor (RFF) velocity with multiple secondary endpoints to assess muscle and pulmonary function -

- FORZETTO trial design and protocol aligned with FDA; trial intended to serve as confirmatory trial for traditional approval in the U.S. and support ex-U.S. marketing applications -

WALTHAM, Mass., May 20, 2026 (GLOBE NEWSWIRE) -- Dyne Therapeutics, Inc. (NASDAQ:DYN), a clinical-stage company focused on delivering functional improvement for people living with genetically driven neuromuscular diseases, today announced the initiation of the Phase 3 FORZETTO trial of zeleciment rostudirsen (z-rostudirsen, also known as DYNE-251), in individuals with Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. The design of the FORZETTO trial will be presented at the 19th International Congress on Neuromuscular Diseases (ICNMD) being held July 7-11, 2026, in Florence, Italy.