08:26 AM EDT, 06/29/2026 (MT Newswires) -- Larimar Therapeutics ( LRMR ) said Monday that it has filed the first module of its rolling Biologics License Application submission with the US Food and Drug Administration for nomlabofusp, a potential treatment for Friedreich's ataxia.

The company expects to submit the remaining modules in H2. The filing follows a Type B pre-BLA meeting with the FDA, it said.

Larimar said the regulator indicated its current data package may support review under accelerated approval. The company said it is proposing skin frataxin levels as a surrogate endpoint.

Larimar also reported long-term open-label study data showing sustained increases in frataxin protein levels and improvements in clinical measures compared with natural history data. The treatment was generally well tolerated, though some adverse events, including injection site reactions and cases of anaphylaxis, were reported, it said.

The company said it plans to begin a global late-stage confirmatory study this year and is targeting a potential launch next year, pending approval.

Larimar Therapeutics ( LRMR ) stock fell 20% in recent Monday premarket activity.