Larimar Therapeutics Submits First Module Of Rolling BLA Submission To FDA For Accelerated Approval Of Nomlabofusp; Remaining Modules Expect

FDA alignment on submission of BLA data package in multi-disciplinary Type B pre-BLA meeting minutes; first module of rolling BLA submitted with remaining modules expected 2H 2026 Daily nomlabofusp increased and sustained skin FXN levels at 1 year and 18 months; 100% (9/9) of participants achieved and maintained levels over 50% of mean levels in healthy volunteers (comparable to asymptomatic heterozygous carriers) at 1-year Continued directional improvement across mFARS, FARS-ADL, 9-HPT, MFIS observed at 1 year of nomlabofusp treatment (n = 13) relative to a worsening in a FACOMS natural history study reference population One of six non-ambulatory participants at baseline became ambulatory after 1 year of dosing; none of the seven ambulatory participants progressed to non-ambulatory at 1 year Well-characterized safety profile; long-term dosing continues to be generally well-tolerated; anaphylaxis occurred in 10/43 patients with 9 of the 10 having exposure to nomlabofusp in a prior study 11 participants had no exposure to nomlabofusp in a prior study; 1 experienced anaphylaxis Dosing of first patient in global confirmatory Phase 3 study expected Q3 2026 Company management to host webcast and conference call today at 7:45 a.m.

EDT BALA CYNWYD, Pa., June 29, 2026 (GLOBE NEWSWIRE) -- Larimar Therapeutics, Inc. (Larimar) (NASDAQ: LRMR ), a clinical-stage biotechnology company focused on developing treatments for complex rare diseases, today announced it has submitted the first module of its rolling Biologics License Application (BLA) submission to the Food and Drug Administration (FDA) for accelerated approval of nomlabofusp; the remaining modules are expected to be submitted in the second half of 2026.

The submission was made after obtaining FDA meeting minutes of a Type B multidisciplinary pre-BLA meeting.

The Company also announced positive data from the ongoing long-term open label (OL) study evaluating daily subcutaneous injections of nomlabofusp in adolescent and adult patients with Friedreich’s ataxia (FA).

FA is a rare, progressive, and fatal neurological disease with no approved disease modifying therapies that address the root cause of the disease.