Dyne Therapeutics reported pivotal-study success for its exon‑51 skipping Duchenne muscular dystrophy candidate and signaled plans to seek accelerated FDA approval. In a registrational expansion cohort, treated patients reached adjusted dystrophin expression of 5.46% of normal after six months, substantially higher than historical comparators, and showed functional improvements across multiple endpoints. The company reported a favorable safety profile with mostly mild-to-moderate events and no related serious TEAEs in the registrational group. Dyne plans a rolling submission for accelerated approval in 2026 and is building commercial and CMC capacity ahead of a potential 2027 launch.