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Actinogen Secures FDA Nod on Xanamem’s Alzheimer’s Trial Blueprint
9:12am on Monday 15th of September, 2025 AEST
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Biotechnology
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Actinogen Secures FDA Nod on Xanamem’s Alzheimer’s Trial Blueprint
9:12am on Monday 15th of September, 2025 AEST
Key Points
FDA agreement on manufacturing and clinical trial design for Xanamem
One additional pivotal Phase 3 trial with a single 10 mg dose versus placebo
Limited ancillary clinical pharmacology and nonclinical studies required
Clear pathway established for New Drug Application submission in the US
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