Larimar: FDA Removed Partial Clinical Hold for Nomlabofusp Program in Friedreich’s Ataxia

 

• 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

https://www.globenewswire.com/news-release/2024/05/20/2885137/0/en/Larimar-Therapeutics-Announces-FDA-has-Removed-Partial-Clinical-Hold-for-Nomlabofusp-Program-in-Friedreich-s-Ataxia.html