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Sahm Platform 02/12 01:36
Larimar Therapeutics Announces FDA Recommendations On Safety Database And Sets Q2 2026 Nomlabofusp BLA Submission For Friedreich's Ataxia
LARIMAR THERAPEUTICS INC +11.22% Pre
LARIMAR THERAPEUTICS INC LRMR | 0.00 |
- Interactions with FDA over the past year have provided clear expectations for the path to submission of the nomlabofusp BLA
- Written FDA recommendations for safety database include a total of at least 30 participants with continuous exposure for 6 months including a subset of at least 10 with 1-year; large majority of the exposure should be on the 50 mg dose
- BLA submission seeking accelerated approval planned in the second quarter of 2026 to allow for inclusion of the recommended safety data for adults and children
- OLE data expected in September 2025 from 30-40 participants who received at least one dose of nomlabofusp; data will include participants on the 50 mg dose
- Adolescent PK run-in data expected in September 2025 from 14 participants (some on placebo); participants currently screening and enrolling into OLE
- Global Phase 3 study activities are ongoing with identification and qualification of sites in U.S., Europe, U.K., Canada, and Australia
- Company management to host webcast and conference call today at 8:00 a.m. ET
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