Larimar Therapeutics Announces FDA Breakthrough Therapy Designation for Nomlabofusp in FA and Reiterates Planned BLA Submission in June 2026

Nomlabofusp program granted Breakthrough Therapy Designation for the treatment of adults and children with FA based on FDA’s review of available clinical data from open label studyFDA written communications after recent START meeting continue to align with use of skin FXN to support BLA submission seeking accelerated approvalTopline open label study data to support BLA submission expected in Q2 2026 Planned BLA submission seeking accelerated approval on track for June 2026; U.S. launch targeted for first-ha ...