FDA alignment supports a rolling BLA submission for nomlabofusp in Friedreich's ataxia, with positive open-label data showing sustained FXN increases and clinical improvements over 1–18 months. Safety profile remains consistent, and Phase 3 dosing is planned for Q3 2026.Original document: Larimar T…
FDA alignment supports a rolling BLA submission for nomlabofusp in Friedreich's ataxia, with positive open-label data showing sustained FXN increases and clinical improvements over 1–18 months. Safety profile remains consistent, and Phase 3 dosing is planned for Q3 2026.
Original document:
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