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Neurizon Advances ALS Drug with Key GMP Manufacturing Milestone

9:02am on Thursday 4th of December, 2025 AEDT Biotechnology
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Neurizon Advances ALS Drug with Key GMP Manufacturing Milestone

9:02am on Thursday 4th of December, 2025 AEDT
Key Points
  • Three GMP registration batches of NUZ-001 tablets completed ahead of schedule
  • Manufacturing conducted by Catalent at commercial scale under FDA and ICH guidelines
  • Batches support FDA Rolling Review and stability studies for NDA submission
  • On track to start patient enrollment in HEALEY ALS Platform Trial in Q1 2026
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