Larimar Therapeutics reports Q3 EPS (61c), consensus (42c)

“We were pleased to recently share exciting long-term data from our open label study showing consistent directional improvement across four key clinical outcome measures relative to a Friedrich’s Ataxia Clinical Outcomes Measure Study reference population, and increased skin frataxin levels similar to asymptomatic carriers. These findings underscore the potential of daily nomlabofusp treatment to help change the disease course of patients living with Friedreich’s ataxia, including those with advanced disease,” said Carole Ben-Maimon, MD, President, and Chief Executive Officer of Larimar. “We are implementing a modification to the starting dose regimen to help mitigate the risk of occurrence of anaphylactic reactions which seem to be more common in participants with prior exposure to nomlabofusp. Long-term treatment with daily nomlabofusp, including 8 participants for over 1 year, was generally well-tolerated. With this positive data in hand, and a targeted path to registration, we continue to target our Biologics License Application submission in the second quarter of 2026 seeking accelerated approval. We plan to provide a nomlabofusp development program update that will include status on our regulatory discussions and OL study in the first quarter of 2026. We are focused on execution of our near-term milestones that will advance nomlabofusp as the first potential disease modifying therapy designed to address the root cause of FA.”