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Larimar Therapeutics plans rolling BLA submission for Friedreich’s ataxia drug nomlabofusp in June 2026.

Company Fundamentals
14 May 2026
GlobeNewsWire
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Bullish
pluang ai news

Larimar Therapeutics announced plans to initiate a rolling Biologics License Application (BLA) submission in June 2026 for nomlabofusp, targeting accelerated FDA approval for treating Friedreich’s ataxia. The company expects to submit nonclinical and clinical data modules first, with the final chemistry, manufacturing, and controls (CMC) module to follow in the second half of 2026. Topline data from an open-label study supporting the BLA is anticipated in Q2 2026, alongside plans to start a global Phase 3 confirmatory trial mid-year. Larimar holds $200.4 million in cash, supporting operations into Q2 2027, and aims for a potential product launch in the first half of 2027 if approved.

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