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Actinogen achieves agreement with the FDA in a Type C meeting on the manufacturing, clinical and nonclinical activities required for a future US marketing approval of Xanamem for Alzheimer’s disease

Current XanaMIA pivotal phase 2/3 trial on track for interim analysis in January 2026 and final results late 2026 with trial enrolment expected to close in Q4 2025SYDNEY, Sept. 15, 2025 (GLOBE NEWSWIRE) -- Actinogen Medical Limited (ASX: ACW) announces the successful conduct of its scheduled Type C meeting (written response) on Alzheimer’s disease (AD) with the US Food & Drug Administration (FDA). Actinogen and the FDA reached a common understanding of the pathway to marketing approval in AD - m

articleActinogen Medical LimitedSeptember 15, 20255/company/actinogen-medical-ltd/news/actinogen-achieves-agreement-fda-type-123000311
Actinogen achieves agreement with the FDA in a Type C meeting on the manufacturing, clinical and nonclinical activities required for a future US marketing approval of Xanamem for Alzheimer’s disease

About this update from Actinogen Medical Limited

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Alzheimer’s diseaseclinical pharmacologyUS Food & Drug Administrationclinical trialEuropean Medicines Agencydrug substancepivotal trialDr Steven GourlayACWThe CompanyNew Drug Applicationclinical development