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

Larimar Therapeutics (LRMR)Larimar TherapeuticsFDA / regulatory

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 study FDA written communications after recent START meeting continue to align with use of skin FXN to support BLA submission

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Larimar Therapeutics

Intracellular Protein Delivery Larimar Therapeutics develops fusion proteins that deliver functional biological material into cells. Its lead program addresses a rare disease caused by deficiency of the intracellular protein frataxin. Nomlabofusp Nomlabofusp is a recombinant fusion protein designed to deliver human frataxin into the...

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