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Actinogen opens long-term Xanamem extension in pivotal Alzheimer’s trial

Story Highlights
  • Actinogen has launched an open-label XanaMIA extension, giving all eligible Alzheimer’s trial participants up to 25 months of daily Xanamem treatment.
  • Running alongside the randomized XanaMIA study, the extension aims to strengthen long-term safety and efficacy data to support future regulatory applications for Xanamem.
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Actinogen opens long-term Xanamem extension in pivotal Alzheimer’s trial

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An announcement from Actinogen Medical ( (AU:ACW) ) is now available.

Actinogen Medical has begun the open-label extension phase of its XanaMIA Phase 2b/3 Alzheimer’s trial, allowing all former and current randomized-phase participants in Australia and the U.S. to receive active Xanamem 10 mg once daily for up to 25 months. The extension is designed to generate longer-term safety and observational efficacy data, including measures such as the CDR-SB, cognition and daily functioning, which can be analyzed progressively and benchmarked against historical control cohorts.

The randomized, placebo-controlled phase of XanaMIA continues in parallel, with topline results expected in November 2026, following earlier clearance from an independent Data Monitoring Committee. By running the open-label extension alongside the pivotal trial, Actinogen aims to build a more robust data package to support future regulatory marketing applications and to further position Xanamem as a potentially differentiated, convenient oral alternative to anti-amyloid antibody therapies that require intensive MRI safety monitoring.

The most recent analyst rating on (AU:ACW) stock is a Sell with a A$0.03 price target. To see the full list of analyst forecasts on Actinogen Medical stock, see the AU:ACW Stock Forecast page.

More about Actinogen Medical

Actinogen Medical is an ASX-listed biotechnology company developing Xanamem, a novel oral therapy targeting neurological and neuropsychiatric diseases linked to dysregulated brain cortisol. The company is focused primarily on Alzheimer’s disease, but has also explored treatment-resistant depression and is considering indications such as Fragile X Syndrome and other brain disorders with significant unmet medical need.

Average Trading Volume: 4,531,810

Technical Sentiment Signal: Strong Sell

Current Market Cap: A$118.5M

Learn more about ACW stock on TipRanks’ Stock Analysis page.

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