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Z-rostudirsen (DYNE-251)Dyne Therapeutics—FDA accepts z-rostudirsen BLA with Priority Review; PDUFA January 21, 2027Z-rostudirsen (DYNE-251)Dyne Therapeutics—Dyne submits z-rostudirsen BLA for Duchenne exon 51

Z-rostudirsen (DYNE-251)

by Dyne TherapeuticsUS

Halt or reverse Duchenne progression in exon 51-amenable patients by restoring dystrophin production.

PilotStage 3 of 5

BLA accepted July 2026 with Priority Review; PDUFA January 21, 2027.

Updated 20 Jul 2026Checked 11 Oct0 updates this week

Milestones

Next · FORZETTO Phase 3 confirmatory ongoing
  1. DELIVER Phase 1/2 positive data2026Complete.
  2. BLA submitted to FDA26 May 2026Complete.
  3. FDA accepts BLA, Priority Review20 Jul 2026Complete.
  4. FORZETTO Phase 3 confirmatory ongoingTarget 2026Current milestone.
  5. FDA decision (PDUFA)Target 21 Jan 2027Not yet reached.

Most important updates

Upcoming

  1. 2026FORZETTO Phase 3 confirmatory ongoing (next)
  2. 21 Jan 2027FDA decision (PDUFA)
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