- 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 the second half of 2025
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