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Actinogen Secures FDA Alignment on Xanamem’s Path to Alzheimer’s Approval.
Actinogen Medical Limited (ASX: ACW) has announced a significant milestone in the development of Xanamem®, its lead therapy for Alzheimer’s disease (AD). Following a successful Type C meeting with the US Food and Drug Administration (FDA), the Company now has clear guidance on the remaining clinical, manufacturing, and regulatory requirements for a New Drug Application (NDA) submission in the US.

Noel Ong
Sep 245 min read


Actinogen Medical Limited (ASX: ACW) Highlights Xanamem’s Dual Potential at World’s Leading Dementia Forum – The AAIC 2025.
Actinogen Medical Limited (ASX: ACW) has added another important milestone in its clinical development journey, showcasing new data that reinforces the mechanism and therapeutic promise of Xanamem® (emestedastat). The company’s Chief Medical Officer, Dr Dana Hilt, and Senior Clinical Scientist, Dr Jack Taylor, are presenting a scientific poster at the prestigious Alzheimer’s Association International Conference (AAIC 2025) in Toronto, the world’s largest platform for dementia

Noel Ong
Aug 156 min read
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