Zeleciment Rostudirsen (DYNE-251) PDUFA date: FDA decision expected January 21, 2027
The FDA is expected to decide on Zeleciment Rostudirsen (DYNE-251) from Dyne Therapeutics, Inc. in DMD who are amenable to exon 51 skipping by the PDUFA target action date of January 21, 2027. For DMD who are amenable to exon 51 skipping. bla filing. Extracted from SEC filing: EX-99.1
A PDUFA date is the FDA's target deadline to complete its review of a drug application — approval, a complete response letter (CRL), or an extension are all possible. What is a PDUFA date? This page is research information, not financial advice.
Source: sec.gov · Data checked October 20, 2026. How we check dates. Confirm dates against the company's or the FDA's announcement before acting.
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Questions about this FDA decision
- When is the PDUFA date for Zeleciment Rostudirsen (DYNE-251)?
- The FDA's PDUFA target action date for Zeleciment Rostudirsen (DYNE-251) is January 21, 2027. The FDA can act before that date, and the review can be extended.
- What is Zeleciment Rostudirsen (DYNE-251) being reviewed for?
- The application under FDA review covers DMD who are amenable to exon 51 skipping.
- Which company is developing Zeleciment Rostudirsen (DYNE-251)?
- Dyne Therapeutics, Inc. (DYN).
- What can happen on a PDUFA date?
- The FDA approves the application, issues a complete response letter (CRL) listing what must be fixed before approval, or extends the review (typically by three months after a major amendment).