Larimar Therapeutics reports Q1 EPS (46c), consensus (41c)

“Our strong execution across our nomlabofusp clinical development program continues and we are focused on delivering the first potential disease modifying therapy to patients with FA. Importantly, with the robust preclinical and clinical data package we have in hand and the additional clinical data readouts coming later this year, coupled with the positive FDA feedback and recommendations in line with our current approach, we are on track to submit our planned Biologics License Application by the end of 2025 to seek accelerated approval,” said Carole Ben-Maimon, MD, President, and Chief Executive Officer of Larimar. “We continue to have frequent communication with the FDA via our START pilot program participation including interactions regarding the adequacy of the safety data set required to support BLA submission. In mid-2025 we expect to initiate our global Phase 3 study following global regulatory feedback on the study protocol, and we also expect to transition to the lyophilized formulation of nomlabofusp. We completed dosing of adolescents in our pharmacokinetic run-in study and expect to report adolescent data from that study, along with data from participants receiving the 50 mg dose of nomlabofusp daily in our long-term open label extension study. This program update will be in September 2025. We look forward to these important near-term catalysts as we work to bring nomlabofusp towards potential registration.”