Larimar Therapeutics submits rolling BLA for nomlabofusp

Shares of US biotech Larimar Therapeutics (Nasdaq: LRMR) closed down 16.5% at $3.06 yesterday, despite the company announcing the submission of the first module of its rolling Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for the accelerated approval of nomlabofusp.

The company anticipates submitting the remaining modules in the latter half of 2026. This submission follows FDA meeting minutes from a Type B multidisciplinary pre-BLA meeting, which confirmed alignment on the data package for submission. Larimar also reported positive data from an ongoing long-term open-label study evaluating daily subcutaneous injections of nomlabofusp in adolescent and adult patients diagnosed with Friedreich’s ataxia (FA), a rare, progressive, and fatal neurological disorder for which no approved disease-modifying therapies currently exist.