Neutral
GlobeNewsWire
2 months ago
Larimar Therapeutics Reports Third Quarter 2025 Financial Results
In the open label (OL) study, after 6-months of daily nomlabofusp administration, 100% of participants (n = 10) achieved skin FXN levels similar to asymptomatic carriers Consistent directional improvement across mFARS, FARS-ADL, 9-HPT and MFIS after 1-year in OL study reinforces the potential of nomlabofusp to alter FA's disease course relative to a worsening in a FACOMS natural history study reference population Of 39 participants in OL study (and of 65 total participants who received at least 1 dose in all nomlabofusp studies), 7 experienced anaphylaxis in the first 6 weeks of dosing and returned to usual state of health after standard treatment; excluding these events, long term dosing of nomlabofusp was generally well tolerated including 8 participants on treatment for over 1 year Anaphylaxis is more common upon re-exposure to a drug after a gap in dosing; in the OL study, of the 10 participants who had not had prior exposure to nomlabofusp only 1 experienced anaphylaxis (this reaction was one of the 7 events discussed above). Implementing a modified starting dose regimen designed to mitigate the risk of anaphylaxis events as agreed to by the FDA Modified starting dose regimen is also being incorporated into the Phase 3 protocol; Larimar continues to qualify global Phase 3 sites and prepare for study initiation and patient enrollment BLA submission seeking accelerated approval targeted in the second quarter of 2026 $175.4 million in cash, cash equivalents and marketable securities as of September 30, 2025, with projected cash runway into the fourth quarter of 2026 BALA CYNWYD, Pa.
