Dyne Therapeutics Submits BLA for z-rostudirsen
Dyne Therapeutics announced the submission of a Biologics License Application, BLA, to the U.S. Food and Drug Administration, FDA, for zeleciment rostudirsen, z-rostudirsen, 20 mg/kg Q4W for the treatment of individuals with Duchenne muscular dystrophy amenable to exon 51 skipping. Dyne has requested Priority Review for the BLA, which, if granted, would shorten the review process from 10 months to 6 months following the FDA's 60-day filing review period. Dyne continues to expect a potential U.S. launch of z-rostudirsen in Q1 2027, assuming the FDA grants Priority Review and approval is received on the anticipated timeline.
