Actinogen Medical advances pivotal XanaMIA trial towards November readout - ICYMI

Actinogen Medical Ltd (ASX:ACW, OTC:ATGGF) earlier this week reported continued progress across its clinical, regulatory and financial programs during the June quarter, with the pivotal XanaMIA Alzheimer’s disease trial remaining on schedule to deliver topline results in November 2026.

Managing Director and CEO Dr Stephen Gourlay said the upcoming readout represented “a potentially transformational event for the company and for the clinical science, and for patients with Alzheimer’s all around the world”.

The fully enrolled Phase 2b/3 study continued treatment, follow-up and data-cleaning activities across participating sites. An independent Data Monitoring Committee also completed its third review of safety data from all 247 participants and recommended that the trial continue without amendment.

The November readout remains the company’s most significant near-term catalyst. Positive results could provide important clinical validation for Xanamem as a once-daily oral treatment for mild to moderate Alzheimer’s disease and support further regulatory and commercial activity.

Actinogen Medical also reported strong participation in the XanaMIA open-label extension. Around 88% of eligible patients completing the randomised study elected to continue immediately into the extension, with 81 patients receiving Xanamem 10 milligrams once daily for up to 25 months.

Gourlay said the extension would provide longer-term safety information and observational data across measures including cognition,...