Search This Blog

Monday, May 11, 2026

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.

No comments:

Post a Comment

Note: Only a member of this blog may post a comment.