Monday, Dyne Therapeutics, Inc. (DYN) announced that the U.S. Food and Drug Administration has accepted the Biologics License Application or BLA for zeleciment rostudirsen for Priority Review and assigned a Prescription Drug User Fee Act target action date of January 21, 2027.
Zeleciment rostudirsen, also known as DYNE-251, is an investigational therapeutic for individuals with Duchenne muscular dystrophy, a rare progressive neuromuscular disorder.
The BLA is backed by findings of the registrational expansion cohort of the global Phase 1/2 DELIVER clinical trial, which met its primary endpoint. Notably, z-rostudirsen continues to be evaluated in the long-term extension portion of the DELIVER trial and in the global confirmatory Phase 3 FORZETTO clinical trial. The company estimates a potential approval in six months and plans to launch z-rostudirsen in the U.S. in the first quarter of 2027.
Moreover, Dyne is also working on four development candidates - DYNE-253, DYNE-245, DYNE-244 and DYNE-255.
In the pre-market hours, DYN is trading at $24.25, up 2.57 percent on the Nasdaq.
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September 04, 2026 15:08 ET The job report and foreign trade data were the main economic news from the U.S. in the first week of September. Elsewhere in North America, the Canadian central bank announced its latest policy decision. Inflation data from Eurozone was the highlight in Europe. The latest interest rate decision by the Reserve Bank of New Zealand drew attention in Asia.