$Larimar Therapeutics (LRMR.US)$ NEWS Larimar Therapeutics A...
NEWS
Larimar Therapeutics Announces FDA has Removed Partial Clinical Hold for Nomlabofusp Program in Friedreich’s Ataxia
Larimar Therapeutics (Nasdaq: LRMR) announced that the FDA has removed the partial clinical hold on their nomlabofusp (CTI-1601) program, aimed at treating Friedreich’s Ataxia (FA). This decision followed the review of data from a recently completed Phase 2 dose exploration study, which included 25 mg and 50 mg cohorts. The study showed that nomlabofusp was well-tolerated and demonstrated dose-dependent increases in frataxin levels. Larimar plans to escalate the dose to 50 mg in the ongoing open-label extension (OLE) study. Interim data from this study is expected in Q4 2024, with a Biologics License Application (BLA) submission targeted for the second half of 2025.
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