Larimar Therapeutics Advances nomlabofusp Application
"We have strong momentum as we advance nomlabofusp towards potential approval for the treatment of adults and children with Friedreich's ataxia. Our ongoing engagement with the U.S. Food and Drug Administration continues to support our registrational strategy. As we are coming down the homestretch for the submission of our BLA, pending FDA feedback, we are planning to seek accelerated approval and initiate a rolling BLA submission in June with the nonclinical and clinical modules. To facilitate a seamless review process, we continue to focus on the completeness of our chemistry, manufacturing, and controls module, and plan to submit the CMC portion of the BLA in the second half of 2026," said Carole Ben-Maimon, President and Chief Executive Officer of Larimar Therapeutics. "We look forward to having a Type B meeting prior to initiating the rolling submission to obtain additional FDA feedback on the BLA content. We expect to report topline data from our open-label study this quarter and plan to dose the first patient in our global confirmatory Phase 3 study in mid-2026. We are focused on disciplined execution to deliver what could become the first disease-modifying therapy for patients living with FA."
