Dyne gets early 2027 decision date for Duchenne therapy, analysts expect ‘smooth’ review

Summary

Dyne Therapeutics received an early 2027 FDA decision date for zeleciment rostudirsen for exon-51 Duchenne muscular dystrophy. Analysts expect the therapy could capture the majority of the market given superior efficacy and dosing compared to Sarepta's Exondys 51.