Actinogen Medical

Actinogen Medical Actinogen is developing a novel therapy for neurological and neuropsychiatric diseases

Actinogen Medical (ASX:ACW) is an ASX-listed biotechnology company developing a novel therapy for neurological and neuropsychiatric diseases associated with dysregulated brain cortisol. There is a strong association between persistent stress and the production of excess cortisol that leads to changes in the brain affecting memory, cognitive function, behaviour and neuropsychological symptoms. Acti

nogen’s lead compound, Xanamem, has been specifically designed to reduce production of intracellular cortisol - the stress hormone - through the inhibition of the 11β-HSD1 enzyme in the brain. The 11β-HSD1 enzyme is highly concentrated in the areas of the brain associated with cognitive impairment in early Alzheimer’s Disease (AD) and Depression, and other neurological and psychiatric diseases. Because of its ability to reach these areas of the brain and inhibit this enzyme, Xanamem is very different from other treatments for cognitive impairment. Actinogen has studied 11β-HSD1 inhibition by Xanamem in more than 300 volunteers and patients, so far finding a statistically significant improvement in working memory and attention, compared with placebo, in healthy, older volunteers in two consecutive trials and clinically significant improvements in patients with biomarker-positive mild AD. Previously, high levels of target engagement in the brain with doses as low as 5 mg daily have been demonstrated in a human PET imaging study. The Company is rapidly moving forward into its upcoming double-blind, randomized, placebo-controlled Phase 2 trials in cognitive impairment in Alzheimer’s Disease and Depression to further confirm and characterize Xanamem’s therapeutic potential. The XanaMIA Phase 2b AD trial comprises 330 patients with mild Alzheimer’s Disease and the XanaCIDD Phase 2a trial will total 160 patients with depression.

A great report by Tim Boreham in Biotech Daily’s “Dr Boreham’s Crucible” 🧬, highlighting the progress of Xanamem’s Alzhe...
13/04/2026

A great report by Tim Boreham in Biotech Daily’s “Dr Boreham’s Crucible” 🧬, highlighting the progress of Xanamem’s Alzheimer’s disease clinical trial. The piece draws on an interview we did late last year and provides a thoughtful overview of where things currently stand.

After successfully passing the pivotal trial’s interim futility and safety analysis in January ✅, we’re now looking ahead to the next major milestone—topline results expected in November 📊.
It’s an exciting period as we continue working toward meaningful outcomes for patients ❤️ and future regulatory pathways.

🔗 Read more:

Published shortly after the stock market closes five days a week - excluding public holidays - Biotech Daily is the only comprehensive daily source of information on the listed biotechnology sector.

We’re pleased to share that Actinogen Medical has commenced the open-label extension of its XanaMIA Alzheimer’s trial, w...
01/04/2026

We’re pleased to share that Actinogen Medical has commenced the open-label extension of its XanaMIA Alzheimer’s trial, with the first participant treated. 🧠✨

This phase allows eligible participants to receive active Xanamem®, helping generate important long-term data.

🔗 Learn more:

Read and interact with this announcement: ACW XanaMIA Alzheimers open label trial commences on Actinogen's investor hub

Actinogen Medical secures $16.8m to fund pivotal Alzheimer's trial.We've successfully completed our capital raising (Pla...
26/02/2026

Actinogen Medical secures $16.8m to fund pivotal Alzheimer's trial.

We've successfully completed our capital raising (Placement and SPP), ensuring our XanaMIA trial is fully funded through its most critical catalyst: topline results in November

This funding follows a string of de-risking milestones:

- FDA alignment on a streamlined pathway to approval ✅
- Full enrolment of the 247-patient Alzheimer’s trial ✅
- Positive interim safety and futility recommendation from our independent Data Monitoring Committee✅

With the major hurdles cleared, we are now in the final countdown to topline results this November.



For more info go to: https://investors.actinogen.com.au/link/PZoJ6y

Actinogen Medical CCO Andrew Udell joined a panel discussion at the Biotech Showcase 2026 in San Francisco this week on ...
13/01/2026

Actinogen Medical CCO Andrew Udell joined a panel discussion at the Biotech Showcase 2026 in San Francisco this week on emerging biotech commercialization models. The insightful session explored how the industry is moving beyond traditional models toward smarter, more capital-efficient paths to market—focusing on value creation, risk management, and the milestones that matter most.

04/11/2025

We’re pleased to share that our CEO, Dr Steve Gourlay, and CCO, Andy Udell, are representing Actinogen Medical at this year’s BIO Europe conference in Vienna (November 3 – 5).

They’ll be connecting with biotech and pharma leaders to explore innovative partnerships and new clinical opportunities.
If you’re attending and would like to meet, send us a message — we’d love to connect!

📣 Actinogen Medical Webinar – Progress Update & Q&AJoin us as  Actinogen Medical, we are hosting a webinar on Tuesday, 2...
23/10/2025

📣 Actinogen Medical Webinar – Progress Update & Q&A

Join us as Actinogen Medical, we are hosting a webinar on Tuesday, 28 October at 11am AEDT!

Hear from CEO Dr Steven Gourlay and senior leaders as they share recent progress and future milestones. Stay for a Q&A session!

✅ Register now: ://actinogenmedical.zoom.us/webinar/register/WN_L_TOuTmaR4qYvYnXrNzfDQ

📺 A recording will be available after the event on our website and YouTube.

📄 Full ASX announcement: https://investors.actinogen.com.au/link/eW3Qje

Read and interact with this announcement: Advance notice ACW progress update and Q&A webinar on Actinogen's investor hub

22/10/2025

Actinogen Medical is making strong progress in our XanaMIA Alzheimer’s trial, with pTau screening now closing early on October 31 thanks to the great work of our research teams and strong participant interest.

With around 240 participants projected and final results expected mid Q4 2026, we’re encouraged by the growing confidence in Xanamem®, our once-daily oral therapy designed to target elevated brain cortisol to help slow Alzheimer’s progression.

A heartfelt thank you to everyone involved — from our clinical partners to participants and their families — for helping move Alzheimer’s research forward. 💙

Read more 👉https://lnkd.in/gHjA7pWj

💜Here at Actinogen we’re recognising World Alzheimer’s and Dementia Week by raising awareness and showing our support fo...
23/09/2025

💜Here at Actinogen we’re recognising World Alzheimer’s and Dementia Week by raising awareness and showing our support for those impacted by Alzheimer’s, along with the families and friends who care for them.

Actinogen Medical featured in news media stories this week in the fight against Alzheimer’s!News Corp mastheads and digi...
19/09/2025

Actinogen Medical featured in news media stories this week in the fight against Alzheimer’s!

News Corp mastheads and digital sites carried the story of positive feedback from the FDA for Actinogen for the clinical development path forward for our once-daily pill, Xanamem.

This breakthrough confirms a clear path to marketing approval and sets the stage for planned global clinical trials.

Aussie innovation leading the way in dementia care!

🔗 Read the full story (News Corp subscribers): http://bit.ly/4pwC3QR

EXCLUSIVE: A once-a-day “holy grail” pill that could change the way Alzheimer’s disease is treated has reached a significant milestone.

Actinogen Medical is delighted to share some great news with you! The FDA has given clear guidance on the next steps for...
15/09/2025

Actinogen Medical is delighted to share some great news with you!

The FDA has given clear guidance on the next steps for Xanamem® in Alzheimer’s disease. This means:
✨ Just one more pivotal trial (10 mg vs placebo), upon success in our current phase 2b/3 XanaMIA trial
✨ A streamlined development path ahead of submission for approval
✨ Confidence to move forward globally

This milestone brings us closer to making a real difference for people living with Alzheimer’s.

Read the full announcement on the Actinogen Investor Hub, including a brief video from CEO, Steven Gourlay: https://investors.actinogen.com.au/link/PKaDVe

News from Actinogen Medical (ASX: ACW)!We’ve just launched our Investor Hub — a new online space where shareholders can:...
12/09/2025

News from Actinogen Medical (ASX: ACW)!
We’ve just launched our Investor Hub — a new online space where shareholders can:
✅ Read the latest ASX announcements
✅ Ask questions and share feedback
✅ Stay informed on our clinical trial program including our XanaMIA phase 2b/3 Alzheimer’s trial, particularly as we approach key milestones

We’re building a stronger connection with our investor community — and we’d love for you to be part of it.

👉 Sign up here: https://investors.actinogen.com.au/link/yMNWle

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Suite 901, Level 9, 109 Pitt Street
Sydney, NSW
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