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FDA Lifts Clinical Hold on Neurizon’s NUZ-001, Paving Way for ALS Trial

9:52am on Wednesday 29th of October, 2025 AEDT Biotechnology
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FDA Lifts Clinical Hold on Neurizon’s NUZ-001, Paving Way for ALS Trial

9:52am on Wednesday 29th of October, 2025 AEDT
Key Points
  • FDA lifts clinical hold on NUZ-001, enabling entry into HEALEY ALS Platform Trial
  • Exclusive global licensing agreement signed with Elanco Animal Health
  • Positive 12-month safety and preliminary efficacy data from Open-Label Extension study
  • GMP manufacturing of NUZ-001 registration batches commenced at Catalent
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