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:

• FDA accepted Dyne's biologics license application for z-rostudirsen (DYNE-251) for DMD amenable to exon 51 skipping.
• BLA granted Priority Review with a Prescription Drug User Fee Act target action date of January 21, 2027.
• Dyne continues to expect a potential U.S. launch of z-rostudirsen in Q1 2027, contingent on approval on the anticipated timeline.

Original SEC Filing:

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