Dyne Therapeutics reported pivotal study success for its exon‑51 skipping therapy in Duchenne muscular dystrophy (DMD) and said it will move toward an accelerated approval filing with the FDA. The company disclosed statistically significant increases in dystrophin expression in its registrational cohort and presented functional endpoint improvements at an ALS/MND meeting and in company materials. In the registrational expansion cohort, Dyne reported mean dystrophin expression of 5.46% of normal (muscle‑content adjusted) after six months — a magnitude Dyne contrasted with prior exon‑skipping comparators — and described consistent directional benefits across motor and pulmonary measures. CEO John Cox called the results “unprecedented” and said the company plans an FDA submission in the second quarter of next year. The program targets patients amenable to exon‑51 skipping, roughly 13% of the DMD population; exon skipping is a genetic approach that masks a faulty exon to restore a truncated, partially functional dystrophin protein. Dyne also expanded commercial and CMC capabilities in preparation for a potential 2027 launch.