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DYNE 101

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Drug Profile

DYNE 101

Alternative Names: DYNE-101

Latest Information Update: 23 Jun 2025

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At a glance

  • Originator Dyne Therapeutics
  • Class Antibodies; Antisense oligonucleotides; Drug conjugates; Immunoconjugates; Immunoglobulin fragments
  • Mechanism of Action Myotonin protein kinase expression inhibitors; RNA interference
  • 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

  • 17 Jun 2025 DYNE 101 receives Breakthrough Therapy status for Myotonic dystrophy in USA
  • 17 Jun 2025 Dyne Therapeutics plans a submission for U.S. Accelerated Approval in late 2026
  • 17 Jun 2025 Dyne Therapeutics plans a phase III trial in Myotonic dystrophy type 1 (DM1) in Q1 2026

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