Larimar completes rolling BLA for nomlabofusp in Friedreich's ataxia; cash $128.7M

Larimar Therapeutics, Inc.

• Rolling Biologics License Application submitted to FDA seeking accelerated approval of nomlabofusp, a frataxin replacement therapy, for Friedreich's ataxia.
• BLA relies on skin frataxin as a potential novel surrogate endpoint; FDA previously confirmed the data package appears capable of supporting submission and review.
• Preliminary cash, cash equivalents and marketable securities of ~$128.7M as of Sept 30, 2026; quarter-end close still ongoing and figure unaudited.
• Milestones: BLA acceptance early 2027, open-label safety update Q1 2027, U.S. approval mid-2027, launch targeted Q3 2027, if approved.
• FORWARD-FA confirmatory Phase 3 enrolling: double-blind, placebo-controlled, 18 months, ages 2-40, ~two-thirds under 21; Breakthrough and Orphan designations held.