Biotech News
Dyne Therapeutics Announces U.S. FDA Acceptance of Biologics License Application (BLA) for Z-Rostudirsen in Exon 51 Duchenne Muscular Dystrophy (DMD)
- Priority Review granted; PDUFA target action date set for January 21, 2027 - - Submission for Accelerated Approval based on dystrophin as a surrogate endpoint - - In the registrational expansion cohort of the DELIVER trial, treatment with z-rostudirsen once every 4 weeks resulted in a robust and