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FDA Clears Neurizon’s NUZ-001 for Pivotal ALS Platform Trial Entry

8:35am on Thursday 11th of December, 2025 AEDT Biotechnology
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FDA Clears Neurizon’s NUZ-001 for Pivotal ALS Platform Trial Entry

8:35am on Thursday 11th of December, 2025 AEDT
Key Points
  • FDA approval granted for NUZ-001 regimen in HEALEY ALS Platform Trial
  • NUZ-001 designated as Regimen I in the adaptive multi-drug trial
  • Clinical site activations and IRB approvals underway ahead of 2026 enrollment
  • Trial aims to accelerate development of new ALS therapies
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