Larimar's Nomlabofusp Increases Skin Frataxin Among Participants, Stock Down In Pre-Market

Core Insights - Larimar Therapeutics, Inc. (LRMR) announced positive data from a long-term open-label study evaluating nomlabofusp for Friedreich's ataxia, a rare neurological disease [1] - The study showed that nomlabofusp significantly increases skin frataxin levels, achieving tissue FXN levels comparable to over 50% of those found in healthy volunteers [2] - Consistent improvements were observed across four key clinical outcomes after one year of treatment, indicating potential clinical benefits [3] Study Details - Participants initially received a daily dose of 25 mg of nomlabofusp, which was later increased to 50 mg in Q4 2024 [1] - Anaphylaxis was reported in seven participants, prompting the company to consult experts and modify the starting dose regimen [3] Future Plans - The new dosing regimen is expected to be implemented in the open-label study in Q4 2025 [4] - Process performance qualification for the commercial scale drug substance is planned for Q4 2025, with a BLA submission anticipated in Q2 2026 [4] - Following the announcement, LRMR's stock price decreased by 30.72% to $3.53 on Nasdaq [4]