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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: 30 Jul 2025

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At a glance

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

Most Recent Events

  • 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.
  • 23 Jun 2025 According to a Larimar Therapeutics media release, FDA safety database recommendations and refined timeline for Biologics License Application (BLA) submission to allow for the inclusion of the recommended safety data from adults and children with Friedreich's Ataxia (FA). This comes following written responses from the U.S. Food and Drug Administration (FDA) based on discussions under the Support for Clinical Trials Advancing Rare Disease Therapeutics (START) pilot program.
  • 24 Mar 2025 According to a Larimar Therapeutics media release, FDA and EMA feedback obtained on global Phase 3 study protocol.

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