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Actinogen Medical Limited (ASX:ACW)

ALERT: Price-sensitive ASX Announcement for ACW
Current share price for ACW : $0.063 0.025 (65.79%)+
Announcement
Release
28 May 2026 9:51AM
Price at Release
$0.038
Full Release
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Summary
Actinogen Medical Limited announced that it has received positive scientific advice from the European Medicines Agency (EMA), which supports the company's regulatory strategy for its Alzheimer's disease drug, Xanamem®. This advice aligns with previous guidance from the U.S. FDA, paving the way for streamlined development towards marketing approval in both the EU and the US. Key agreements with EMA include regulatory starting materials, clinical trial design, and broad inclusion criteria for trial participants. Xanamem®, which targets cortisol regulation in the brain, has shown promise in treating Alzheimer's through various clinical trials. This EMA guidance is crucial for Actinogen’s plans to obtain marketing approval in major pharmaceutical markets.
Key Points
  • Actinogen Medical Limited received positive scientific advice from the European Medicines Agency (EMA).
  • The advice aligns with prior guidance from the U.S. FDA for their Alzheimer's disease program.
  • EMA and Actinogen agreed on the regulatory requirements for Xanamem®, including the design of a pivotal clinical trial.
  • The EMA prefers broader inclusion criteria for the trial, encompassing more patients with moderate Alzheimer's.
  • Actinogen has conducted extensive studies on Xanamem's safety and efficacy, with over 500 participants in various trials.
  • Xanamem is designed to regulate cortisol in the brain, which is associated with cognitive decline in Alzheimer's.
  • The results from these trials are expected to provide pivotal data for future marketing applications in the EU.
IMPORTANT NOTE: This information is autogenerated and has not been reviewed for accuracy or completeness. You should refer to the full announcement here for further information.