DYN biotech catalysts & pipeline

DYNE THERAPEUTICS INC · Data as of 2026-10-25

Upcoming catalysts

zeleciment basivarsen (DYNE-101) — Topline data

Q1 2027

Dyne continues to expect topline data in Q1 2027 from the ACHIEVE registrational expansion cohort (REC), with a primary endpoint of change from baseline in vHOT at 6 months, intended to support a potential submission for U.S. Accelerated Approval in Q3 2027 -

Source filing

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

Dyne continues to expect topline data in Q1 2027 from the ACHIEVE registrational expansion cohort (REC), with a primary endpoint of change from baseline in vHOT at 6 months, intended to support a potential submission for U.S. Accelerated Approval in Q3 2027 -

Source filing

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