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

Dyne Therapeutics (DYN)Dyne TherapeuticsFDA / regulatory

- Submission for Accelerated Approval based on dystrophin as a surrogate endpoint - - In the registrational expansion cohort of the DELIVER trial, treatment with z-rostudirsen resulted in a robust and statistically significant increase in dystrophin production with functional improvement observed

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DYNDyne Therapeutics2026-07-20 11:30 EST

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

DYNDyne Therapeutics2026-05-20 11:46 EST

Dyne Therapeutics Announces Initiation of Phase 3 FORZETTO Trial of Z-Rostudirsen in Duchenne Muscular Dystrophy (DMD) Ahead of Planned BLA Submission for U.S. Accelerated Approval

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Dyne Therapeutics

Oligonucleotide Therapeutics Dyne Therapeutics develops targeted oligonucleotide medicines for genetically driven muscle diseases. Its FORCE platform links therapeutic payloads to antibodies intended to improve delivery into muscle tissue. Duchenne Muscular Dystrophy Z-rostudirsen is designed for patients with Duchenne muscular dystrophy...

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Stock data

Close
26.10 USD
Market cap
2.85B USD
Exchange
NASDAQ
Sector
Biopharma
Location
United States