Posted by Michael Wonder on 27 May 2026
Dyne Therapeutics announces submission of biologics license application to US FDA for z-rostudirsen in exon 51 Duchenne muscular dystrophy
26 May 2026 - Submission for accelerated approval based on dystrophin as a surrogate outcome.
Dyne Therapeutics today announced the submission of a biologics license application to the US FDA for zeleciment rostudirsen (z-rostudirsen, also known as DYNE-251) 20 mg/kg Q4W for the treatment of individuals with Duchenne muscular dystrophy amenable to exon 51 skipping.
