Dyne Therapeutics Reports Second Quarter 2026 Financial Results and Recent Business Highlights
Dyne Therapeutics reported its second quarter 2026 financial results and highlighted that the FDA accepted its Biologics License Application for z-rostudirsen in exon 51 Duchenne muscular dystrophy, granting Priority Review with a PDUFA target action date of January 21, 2027.
Why it matters — The FDA acceptance and Priority Review of the BLA bring z-rostudirsen, Dyne's key therapeutic candidate, one step closer to potential approval, a major regulatory milestone for the company.