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Dyne's BLA for z-rostudirsen accepted by FDA; Priority Review, PDUFA Jan 21, 2027

Dyne announced FDA acceptance of its BLA for z-rostudirsen with Priority Review and a Jan. 21, 2027 PDUFA date.Key Highlights:Original SEC Filing: Dyne Therapeutics, Inc. [ DYN ] - 8-K - Jul. 20, 2026This is an AI-powered summary. It may contain inaccuracies. Consider verifying important informatio…

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Dyne Therapeutics Announces U.S. FDA Acceptance of Biologics License Application (BLA) for Z-Rostudirsen in Exon 51 Duchenne Muscular Dystrophy (DMD)

- Priority Review granted; PDUFA target action date set for January 21, 2027 -- Submission for Accelerated Approval based on dystrophin as a surrogate endpoint -- In the registrational expansion cohort of the DELIVER trial, treatment with z-rostudirsen once every 4 weeks resulted in a robust and st…

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