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SGT 003

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Drug Profile

SGT 003

Alternative Names: SGT-003

Latest Information Update: 11 Feb 2026

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At a glance

  • Originator Solid Biosciences
  • Class Gene therapies
  • Mechanism of Action Dystrophin replacements; Gene transference
  • 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 No

Highest Development Phases

  • Phase III Duchenne muscular dystrophy

Most Recent Events

  • 09 Feb 2026 Solid Biosciences aligns with the US FDA on the overall study design for the phase III IMPACT DUCHENNE trial
  • 09 Feb 2026 Solid Biosciences plans for additional meetings with the US FDA for Duchenne muscular dystrophy to align on a potential accelerated approval pathway for SGT 003, in 1H 2026
  • 09 Feb 2026 Updated adverse events data from the phase I/II INSPIRE DUCHENNE trial in Duchenne muscular dystrophy released by Solid Biosciences

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