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DYN PDUFA Date: Z-rostudirsen

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 5:03 AM ET
FDA decision (PDUFA) target Jan 21, 2027 · Dyne Therapeutics, Inc. · Duchenne muscular dystrophy amenable to exon 51 skipping
Source: Dyne 8-K 2026-07-29 (EX-99.1, BLA accepted, priority review). “PDUFA target action date set for January 21, 2027”

Key facts

FDA PDUFA target date2027-01-21
Drug / candidateZ-rostudirsen
IndicationDuchenne muscular dystrophy amenable to exon 51 skipping
CompanyDyne Therapeutics, Inc.
Market-cap tierMid

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FAQ

When is the DYN PDUFA date?
The FDA PDUFA target date for DYN (Dyne Therapeutics, Inc.) is 2027-01-21 for Z-rostudirsen. Dates are company/FDA-sourced and can slip. Verify against primary filings.
What is DYN's drug Z-rostudirsen?
Z-rostudirsen is Dyne Therapeutics, Inc.'s candidate under FDA review for Duchenne muscular dystrophy amenable to exon 51 skipping.