Larimar Therapeutics reports Q2 EPS (41c), consensus (49c)

“We are pleased with our continued strong execution as we further advance our nomlabofusp program towards potential registration. Importantly, we have written communications in hand from the Food and Drug Administration for key elements of our Biologics License Application submission including safety database recommendations and a potential accelerated approval pathway based on the use of skin frataxin levels as a novel surrogate endpoint. We also recently published two peer-reviewed papers, including nonclinical data contributing to the FDA’s openness to using skin frataxin concentrations as a reasonably likely surrogate endpoint,” said Carole Ben-Maimon, MD, President, and Chief Executive Officer of Larimar. “Enrollment in our open label study is ongoing, and new study participants are now receiving the lyophilized formulation of nomlabofusp. We have several important near-term catalysts ahead including initial data from the 50 mg dose of our open label study and data from the adolescent pharmacokinetic run-in study expected in September 2025. Global sites have been identified for our Phase 3 trial, and we expect to initiate patient recruitment later this year. With our balance sheet strengthened through our recent capital raise, key clinical data approaching, and a clear regulatory path in place, we are well-positioned to submit our BLA for nomlabofusp in the second quarter of 2026 as the first potential disease modifying therapy for Friedreich’s ataxia.”