other material
confidence high
sentiment positive
materiality 0.65
Larimar doses first patient in open-label extension study of nomlabofusp for Friedreich's ataxia
Larimar Therapeutics, Inc.
- First patient dosed in OLE evaluating 25 mg daily subcutaneous nomlabofusp for Friedreich's ataxia.
- OLE to assess long-term safety, pharmacokinetics, and tissue frataxin levels; initial data expected Q4 2024.
- Frataxin data from OLE and prior studies intended to support BLA for accelerated approval targeted H2 2025.
- Nomlabofusp remains under partial clinical hold; 50 mg cohort data will be submitted to FDA for dose escalation review.