Larimar Therapeutics Inc. (NASDAQ:LRMR) said Monday it has submitted the first module of a rolling Biologics License Application to the U.S. Food and Drug Administration seeking accelerated approval for nomlabofusp, its investigational treatment for Friedreich’s ataxia.
The filing follows feedback from a multidisciplinary Type B pre-BLA meeting in which the FDA indicated the existing data package appears capable of supporting a biologics application.
The clinical-stage biotechnology company also released updated long-term data from its ongoing open-label study of nomlabofusp in adolescent and adult patients with Friedreich’s ataxia, a rare, progressive neurological disease.
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