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.

Actinogen Medical Ltd (ASX: ACW) has announced a significant milestone in the development of its lead candidate, Xanamem®(emestedastat), with the 100th participant now enrolled in its pivotal XanaMIA Phase 2b/3 Alzheimer’s disease trial. This event formally triggers the timeline for an independent interim analysis of safety and efficacy, bringing the company one step closer to potentially introducing a novel oral therapy for Alzheimer’s disease (AD).