Larimar Therapeutics Completes Rolling BLA Submission for Nomlabofusp

Larimar Therapeutics completed its rolling Biologics License Application submission to the FDA for nomlabofusp, an investigational protein replacement therapy for Friedreich’s ataxia. The company is conducting the global confirmatory Phase 3 FORWARD-FA study to assess the treatment’s efficacy and safety. Larimar expects potential FDA acceptance of the application in early 2027 and is targeting U.S. approval and launch in mid-to-late 2027, subject to regulatory review.