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Actinogen Medical Limited (ASX:ACW)

ALERT: Price-sensitive ASX Announcement for ACW
Current share price for ACW : $0.046 0.005 (12.20%)+
Announcement
Release
26 Feb 2026 10:27AM
Price at Release
$0.041
Full Release
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Summary
Actinogen Medical Limited announced significant progress in its XanaMIA Alzheimer's trial, completing participant enrolment and receiving a positive interim safety and efficacy review from the Data Monitoring Committee (DMC). The company is set to commence an open-label extension phase, allowing extended treatment with Xanamem. Actinogen has also finalized a streamlined regulatory path for future trials with the FDA and completed commercial-grade manufacturing of Xanamem tablets. The company reported a net loss of $11.3 million for the half-year, primarily due to R&D expenditures, but maintains a strong cash position to support upcoming milestones. The positive interim analysis reinforces confidence in Xanamem's potential as a transformative therapy for Alzheimer's disease.
Key Points
  • Completion of accelerated enrolment in XanaMIA phase 2b/3 Alzheimer's trial with 247 participants.
  • Positive interim safety and efficacy analysis from DMC for XanaMIA trial.
  • Open-label extension phase of XanaMIA trial to commence in Q1 2026.
  • Agreement with FDA on streamlined design for pivotal trial of Xanamem 10 mg vs. placebo.
  • Completion of commercial-grade manufacture of Xanamem tablets for OLE phase.
  • Actinogen received $7.4 million R&D tax incentive for FY2025.
  • Net loss of $11.3 million for half-year ended 31 December 2025, primarily due to R&D costs.
  • Proforma cash balance of $29.7 million as of 31 December 2025.
  • Planning for rapid expansion pending successful phase 2b/3 trial results.
  • Xanamem shows promise as a treatment for Alzheimer's with potential safety and efficacy profile.
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.