Dyne Therapeutics reported that its Duchenne muscular dystrophy exon‑51 exon‑skipping candidate met the primary endpoint in a pivotal study, producing statistically significant increases in dystrophin expression and functional improvements versus placebo. The company said it will pursue an accelerated FDA submission in 2Q next year and is preparing commercial and CMC infrastructure for a potential 2027 launch. In the registrational expansion cohort, treated patients achieved mean dystrophin levels materially above historical comparators; safety was manageable with no related serious adverse events observed. Dyne’s readout intensifies scrutiny of exon‑skipping approaches after mixed results in this class and will test the FDA’s willingness to grant accelerated approvals based on molecular and surrogate endpoints in rare neuromuscular diseases.