Posted by Michael Wonder on 21 Jul 2026
Dyne Therapeutics announces US FDA acceptance of biologics license application for z-rostudirsen in exon 51 Duchenne muscular dystrophy
20 July 2026 - Dyne Therapeutics today announced that the US FDA has accepted for review the biologics license application for zeleciment rostudirsen (z-rostudirsen, also known as DYNE-251) for the treatment of individuals with Duchenne muscular dystrophy amenable to exon 51 skipping.
The FDA has granted the BLA priority review and assigned a PDUFA target action date of 21 January 2027.
