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PDUFAApproval decision

DYNE-251

Duchenne muscular dystrophy

DYNDyne Therapeutics
Expected catalystJanuary 21, 2027Company guidance: Jan 21, 2027

Catalyst overview

Event details

Drug or asset
DYNE-251
Development stage
PDUFA
Event type
Approval decision
Indication
Duchenne muscular dystrophy

Research summary

What is being tracked?

This catalyst tracks a PDUFA approval decision for DYNE-251 in Duchenne muscular dystrophy. The expected timing is based on the latest available company guidance and may change.

Development notes

07/29/26:- PDUFA remains January 21, 2027; potential U.S. launch remains Q1 2027.

Verification

Primary source

Confirm timing and program details against the company announcement or filing.

Open source

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Company

Dyne Therapeutics

DYN · NasdaqGS
Industry
Biotechnology
Pipeline assets
3
View DYN research

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Updated Aug 23, 2026. Dates can change; this is not investment advice.

Disclaimer: Biotech Stock Intel is an independent research platform. Information is provided for informational purposes only and is not investment or medical advice. Always verify catalyst dates against primary sources and conduct your own research.
Biotech Stock Intel© 2026 Biotech Stock Intel
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