Dyne Therapeutics reported that its Duchenne muscular dystrophy candidate met the primary endpoint in a pivotal study and is preparing a regulatory submission. The company presented registrational cohort data showing mean muscle‑content‑adjusted dystrophin of 5.46% of normal after six months, a large step over historical exon‑51 skippers. Dyne cited functional gains across multiple clinical measures and described a favorable safety profile with mostly mild or moderate events. The company plans an accelerated approval filing in the second quarter of next year and has already begun commercial and CMC planning ahead of a potential early 2027 launch.