Shares of Dyne Therapeutics (NASDAQ:DYN) gained 7% after the biotech unveiled encouraging topline findings from its Phase 1/2 DELIVER study evaluating Z-Rostudirsen in Duchenne Muscular Dystrophy (DMD).
According to the update, the trial’s Registrational Expansion Cohort achieved its main goal, delivering a statistically meaningful rise in dystrophin to 5.46% at six months versus baseline. Dyne also highlighted functional gains across several clinical measures at the six-month mark, alongside new long-term data indicating continued functional improvement through 24 months.
Z-Rostudirsen continued to show a clean safety profile, with most treatment-related side effects classified as mild or moderate. Fever and headache were the most frequently reported events, and no treatment-related serious adverse events occurred within the Registrational Expansion Cohort.
The company reiterated that it is on schedule to file for U.S. Accelerated Approval in the second quarter of 2026, which could set up a commercial launch in early 2027 if Priority Review is granted. Dyne also intends to kick off a global Phase 3 study in the second quarter of 2026 to support broader regulatory submissions.
Commenting on the data, Raymond James analyst Michael Freeman wrote, “These results de-risk FDA accelerated approval, in our view, and also provide incremental de-risking for an eventual confirmatory trial,” as he lifted his price target on Dyne to $40 from $35 and kept a Strong Buy rating.
Dyne said the latest findings further reinforce the promise of its FORCE platform, which it believes can drive a pipeline of therapies targeting difficult-to-treat neuromuscular disorders.