Larimar gets FDA safety database guidance; nomlabofusp BLA submission planned for Q2 2026

Larimar Therapeutics, Inc.

FDA recommends safety database of ≥30 participants with 6-month continuous exposure (≥10 with 1-year), majority on 50 mg dose.
BLA submission for accelerated approval now targeted for Q2 2026 to include recommended safety data.
OLE data expected September 2025 from 30-40 participants, including those on the 50 mg dose.
Adolescent PK run-in data also expected September 2025 from 14 participants (some placebo).
FDA open to skin frataxin as reasonably likely surrogate endpoint; global Phase 3 study activities ongoing.

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