Larimar Therapeutics — November 2026 Earnings Summary

Larimar Therapeutics has completed a rolling Biologics License Application submission to the FDA seeking accelerated approval for nomlabofusp to treat Friedreich's ataxia. The application relies on skin frataxin levels as a potential novel surrogate endpoint, supported by data showing sustained increases in these levels and directional clinical improvements in patients. The company is currently enrolling participants in the FORWARD-FA Phase 3 confirmatory study to further evaluate the therapy's safety and efficacy. If approved, the U.S. launch is targeted for the third quarter of 2027.