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Zeleciment Rostudirsen - Dyne Therapeutics

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Drug Profile

Zeleciment Rostudirsen - Dyne Therapeutics

Alternative Names: DYNE-251; z-rostudirsen

Latest Information Update: 06 Aug 2026

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At a glance

  • Originator Dyne Therapeutics
  • Class Antibodies; Antisense oligonucleotides; Drug conjugates; Fab fragments; Immunoconjugates
  • Mechanism of Action Dystrophin expression stimulants; Gene silencing
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Duchenne muscular dystrophy
  • New Molecular Entity Yes

Highest Development Phases

  • Preregistration Duchenne muscular dystrophy

Most Recent Events

  • 20 Jul 2026 FDA assigns PDUFA action date of 21/01/2027 for Zeleciment Rostudirsen for Duchenne muscular dystrophy
  • 20 Jul 2026 US FDA accepts BLA for Zeleciment Rostudirsen for Duchenne muscular dystrophy for review
  • 20 Jul 2026 Zeleciment Rostudirsen receives priority review status for Duchenne muscular dystrophy in USA

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