24 February 2026 - Larimar Therapeutics today announced the US FDA has granted breakthrough therapy designation to nomlabofusp, a frataxin protein replacement therapy with disease modifying potential, for the treatment of adults and children with Friedreich’s ataxia. 

Additionally, after a recent Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program meeting with FDA, the Company announced continued alignment with the FDA to consider the use of skin fraxatin as a novel surrogate outcome reasonably likely to predict clinical benefit to support a planned biologics license application submission seeking accelerated approval.

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