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A global, registrational study of nomlabofusp

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Trial Profile

A global, registrational study of nomlabofusp

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 23 Dec 2024

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At a glance

  • Drugs Nomlabofusp (Primary)
  • Indications Friedreich's ataxia
  • Focus Therapeutic Use
  • Most Recent Events

    • 23 Dec 2024 New trial record
    • 16 Dec 2024 According to a Larimar Therapeutics media release, company is in discussion with FDA on data package required to support accelerated approval, including supplementary nonclinical pharmacology investigations, and FXN, supportive PD, and safety and clinical outcomes data from the OLE study.
    • 16 Dec 2024 According to a Larimar Therapeutics media release, Biologics License Application (BLA) submission targeted for 2H 2025 to support potential accelerated approval

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