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FDA Lifts Clinical Hold on NUZ-001

  • U.S. FDA lifts the Clinical Hold on NUZ‑001, Neurizon®’s lead investigational therapy for ALS
  • Clears the way for entry into the HEALEY ALS Platform Trial expected to commence in Q4 CY2025
  • IND supported by robust preclinical safety data and comprehensive manufacturing and quality information from the previously signed Elanco licensing agreement
  • Expedites NUZ-001 as a platform molecule with pipeline expansion potential for other neurodegenerative diseases
  • Positions Neurizon for accelerated regulatory pathways and future partnering opportunities