zeleciment basivarsen (DYNE-101) — Topline data
Q1 2027
We plan to announce data from the REC in the first quarter of 2027 to support a potential BLA submission to the FDA for U.S. Accelerated Approval in the third quarter of 2027.Source filing
DYN biotech catalysts & pipeline
DYNE THERAPEUTICS INC · Data as of 2026-09-08
Upcoming catalysts
zeleciment rostudirsen (DYNE-251) — PDUFA
Jan 21
The FDA has granted the BLA priority review and assigned a Prescription Drug User Fee Act, or PDUFA, target action date of January 21, 2027.Source filing
zeleciment basivarsen (DYNE-101) — NDA/BLA submission
Q3 2027
We plan to announce data from the REC in the first quarter of 2027 to support a potential BLA submission to the FDA for U.S. Accelerated Approval in the third quarter of 2027.Source filing