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FDA Clears Neurizon’s NUZ-001 for Pivotal ALS Trial in Late 2025

9:03am on Monday 6th of October, 2025 AEDT Biotechnology
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FDA Clears Neurizon’s NUZ-001 for Pivotal ALS Trial in Late 2025

9:03am on Monday 6th of October, 2025 AEDT
Key Points
  • FDA lifts clinical hold on NUZ-001, Neurizon’s lead ALS therapy
  • Entry into HEALEY ALS Platform Trial expected in Q4 2025
  • IND supported by strong preclinical safety and Elanco licensing data
  • Regulatory clearance accelerates development and partnering potential
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