other material
confidence high
sentiment positive
materiality 0.80
Larimar reports positive OLE data: FXN up to 30% of healthy in buccal cells at Day 90; BLA filing targeted 2H 2025
Larimar Therapeutics, Inc.
- Mean change from baseline of 1.32 pg/μg in buccal cells and 9.28 pg/μg in skin cells at Day 90.
- Tissue FXN increased from 15% to 30% of healthy volunteers in buccal cells and 16% to 72% in skin cells.
- Daily 25 mg nomlabofusp generally well tolerated; two SAEs resolved within 24 hours; 50 mg dose escalation initiated.
- BLA submission for potential accelerated approval targeted for 2H 2025; cash runway of $203.7M into Q2 2026.
- Early trends towards improvement in mFARS, ADL, and other clinical outcomes observed at Day 90.