Dyne Therapeutics affirms z-rostudirsen BLA filing for Q2 2026 after positive FDA pre-BLA meeting
Dyne Therapeutics affirms z-rostudirsen BLA filing for Q2 2026 after positive FDA pre-BLA meeting in Q1 update
- Ended Q1 2026 with $972 million in cash, providing operational runway into the first quarter of 2028.
- Company targets potential DMD launch for z-rostudirsen in Q1 2027 following planned Q2 2026 BLA filing.
- Initiated the Phase 3 HARMONIA trial during the first quarter of 2026.
- Reached the enrollment target in the ACHIEVE registrational cohort for z-basivarsen in DM1 in the quarter.
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