Larimar Therapeutics Shares Slide 17% After BLA Module Submission and Positive Trial Data
LRMR•Shares in Larimar Therapeutics fell 17% after it submitted the first rolling BLA module to FDA for nomlabofusp in Friedreich’s ataxia, with the remaining sections planned for H2 2026. Open-label data showed nine participants maintained skin frataxin levels above 50% of healthy volunteers after one year.
1. Regulatory Filing and Share Reaction
Larimar submitted the first module of its rolling BLA for nomlabofusp to FDA following a Type B pre-BLA meeting, triggering a 17% decline in share price on Monday.
2. Long-Term Frataxin Data
Updated open-label trial results showed daily nomlabofusp increased and sustained skin frataxin among all nine participants with one-year follow-up, maintaining levels above 50% of healthy volunteer averages.
3. Safety Findings
Among 43 treated patients, 10 experienced anaphylaxis—nine with prior exposure—while overall tolerability remained favorable over more than 10,000 administered doses.
4. Phase 3 and Commercial Timeline
Larimar plans to enrol the first patient in its global confirmatory Phase 3 trial in Q3 2026, targeting a potential mid-2027 commercial launch pending regulatory approval.
