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Zeleciment Basivarsen - Dyne Therapeutics

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Drug Profile

Zeleciment Basivarsen - Dyne Therapeutics

Alternative Names: DYNE-101

Latest Information Update: 14 Nov 2025

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At a glance

  • Originator Dyne Therapeutics
  • Class Antibodies; Antisense oligonucleotides; Drug conjugates; Immunoconjugates; Immunoglobulin fragments
  • Mechanism of Action Gene silencing; Myotonin protein kinase expression inhibitors
  • Orphan Drug Status

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

    Yes - Myotonic dystrophy
  • New Molecular Entity Yes

Highest Development Phases

  • Phase I/II Myotonic dystrophy

Most Recent Events

  • 06 Nov 2025 Dyne Therapeutics announces intention to launch DYNE 101 for Myotonic dystrophy in Q1 2028, assuming Priority Review
  • 06 Nov 2025 Dyne Therapeutics anticipates submitting a BLA for US Accelerated Approval in early Q3 2027
  • 28 Jul 2025 Dyne Therapeutics plans to complete enrolment in its phase III ACHIEVE trial for Myotonic dystrophy in forth quarter of 2025

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