Actinogen is advancing a revolutionary oral therapeutic, Xanamem^®, through pivotal trials to transform treatment for Alzheimer’s disease and major depressive disorder. Our vision is to improve lives by targeting brain cortisol with precision and innovation.

Advance notice of upcoming investor webinar

ACW will be holding a live webinar at 11am AEDT Tuesday, 28 October 2025. CEO, Dr Steven Gourlay, will outline the company’s significant progress over recent months and discuss key upcoming milestones. Members of the leadership team, Andy Udell, Will Souter & Dr Dana Hilt, will join Dr Gourlay for the presentation & Q&A session.

Pre-register now or register and join on the day by clicking here.

ACW September 2025 quarterly activity report & Appendix 4C

ACW has released its quarterly activity report and Appendix 4C cash flow report for the three-month period ended 30 September 2025.

The announcement on our InvestorHub includes a video summary from CEO Steven Gourlay.

ACW CEO presents at Canaccord/Wilsons Drug & Device conference

CEO, Dr Steven Gourlay, has presented at the Canaccord Drug & Device Conference in Noosa, Queensland

The three-day conference is a key opportunity for leading and emerging biotech, healthcare and lifescience companies to outline their investment value propositions to analysts and institutional investors.

Dr Gourlay’s presentation outlines the success to date of ACW’s clinical development program for its novel oral therapy Xanamem, upcoming milestones, and its large market potential driven by the high unmet need for a safe and effective oral drug in Alzheimer’s disease.

ACW receives Advance Overseas Finding approval, confirming eligibility for further $1.9m R&D rebate

ACW has announced receipt of an Advance Overseas Finding (AOF) for certain overseas R&D activities undertaken during the 2025 financial year worth $1.9m.

If approved by the ATO it will add to the $5.5m R&D rebate recently received, taking total R&D tax incentive cash rebates relating to the 2025 financial year to $7.4m.

ACW achieves early pTau screening closure for XanaMIA trial

ACW has announced that due to the recent accelerated screening and enrolment in the XanaMIA phase 2b/3 Alzheimer’s disease (AD) trial that it will close pTau screening early on 31 October 2025.

ACW releases AGM materials & annual report to shareholders

ACW has released its 2025 Annual General Meeting materials to shareholders including Letter to Shareholders, Notice of AGM and sample proxy voting form.

The company also distributed its 2025 annual report to shareholders who requested a printed copy.

View 2025 Annual Report

ACW announces successful FDA meeting on Alzheimer's program

Actinogen has announced the successful conduct of its scheduled Type C meeting on Alzheimer’s disease (AD) with the US FDA.

Actinogen and the FDA reached a common understanding of the pathway to marketing approval in AD – meaning agreement on regulatory starting materials in drug substance synthesis, the design of one additional pivotal clinical trial and the limited number of ancillary clinical pharmacology trials and nonclinical studies required.