Dyne Therapeutics reported that its Duchenne muscular dystrophy (DMD) exon‑skipping candidate met the primary endpoint in a registrational study and plans to advance an FDA filing in 2Q next year. The registrational expansion cohort showed substantial increases in muscle‑content‑adjusted dystrophin expression and functional improvements versus placebo. Dyne CEO John Cox described the data as unprecedented and outlined an accelerated approval pathway targeting a potential early‑2027 launch. The company emphasized a favorable safety profile with no related serious adverse events in the registrational cohort. If accepted, Dyne’s filing would introduce a new competitor for Sarepta’s exon‑skipping franchise and could reshape treatment options for the subset of DMD patients amenable to exon 51 skipping.