NasdaqGS:DYNBiotechs
Should FDA Priority Review of Dyne’s DMD Drug Candidate Reshape Risk Expectations for Dyne Therapeutics (DYN) Investors?
Dyne Therapeutics, Inc. recently reported that the U.S. FDA accepted for review its biologics license application for zeleciment rostudirsen (z-rostudirsen, DYNE-251) to treat Duchenne muscular dystrophy patients amenable to exon 51 skipping, granting Priority Review with a target action date of January 21, 2027.
The BLA filing is backed by DELIVER trial data showing statistically significant dystrophin increases, functional gains and a favorable safety profile, making z-rostudirsen a key...