Dyne Therapeutics announced that its Duchenne muscular dystrophy (DMD) candidate met the primary endpoint in a pivotal study and the company is preparing an accelerated approval filing with the U.S. Food and Drug Administration. The registrational expansion cohort showed clinically meaningful increases in dystrophin expression when adjusted for muscle content, company data indicate. Dyne presented muscle and functional readouts in a company release and slide deck; CEO John Cox said the data support a near-term filing. The Phase 1/2 Deliver program enrolled patients amenable to exon 51 skipping and reported both biochemical (dystrophin) and functional improvement signals versus placebo. Dyne highlighted a favorable safety profile with mostly mild-to-moderate treatment-emergent adverse events. The company intends to submit for accelerated approval in the second quarter of next year and is building commercial and CMC capacity in parallel.