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A global, registrational study of nomlabofusp

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Trial Profile

A global, registrational study of nomlabofusp

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 14 Mar 2026

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At a glance

  • Drugs Nomlabofusp (Primary)
  • Indications Friedreich's ataxia
  • Focus Therapeutic Use

Most Recent Events

  • 24 Feb 2026 According to a Larimar Therapeutics media release, the company plan to initiate screening in global confirmatory Phase 3 study in Q2 2026; dosing of first patient expected mid-2026.
  • 24 Feb 2026 According to a Larimar Therapeutics media release, the company has clinical trial applications related to Phase 3 study currently under review in France and Canada, with submission to U.K. regulatory authorities soon to follow.
  • 08 Jul 2025 According to a Larimar Therapeutics media release, non-clinical findings were included in the briefing package reviewed by the U.S. Food and Drug Administration (FDA) in support of potentially using skin FXN concentrations as a reasonably likely surrogate endpoint (RLSE) for company's planned BLA submission in Q2 2026 seeking accelerated approval for nomlabofusp.

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