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