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FDA Removed Partial Clinical Hold For Larimar Therapeutics' Nomlabofusp Program In Friedreich's Ataxia

Author: Benzinga Newsdesk | May 20, 2024 04:07pm
  • Food and Drug Administration (FDA) removed partial clinical hold following review of Phase 2 dose exploration study data
  • Ongoing open label extension (OLE) study initially evaluating 25 mg; Larimar plans to dose escalate to 50 mg following further characterization of frataxin pharmacodynamics (PD) at the 25 mg dose
  • Interim data from OLE study remains on track for Q4 2024
    • Biologics License Application (BLA) submission targeted for 2H 2025

Posted In: LRMR


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