Latest Actinogen Medical (ASX:ACW) News

Actinogen Medical has reached a pivotal agreement with the US FDA outlining the regulatory and clinical trial requirements for Xanamem’s approval in Alzheimer’s disease, setting a clear path toward a US marketing application.

Actinogen Medical reports steady progress in its Alzheimer’s and depression drug trials, backed by strong funding and strategic commercial planning. Key interim data from the pivotal XanaMIA trial is expected early next year.

Actinogen Medical reported a $14.7 million net loss for FY25 while progressing its lead drug Xanamem through pivotal Alzheimer’s and depression trials, with interim results expected in January 2026. The company has secured funding through mid-2026 and is preparing for commercialization.

Actinogen Medical has reached a key milestone in its XanaMIA phase 2b/3 Alzheimer’s trial with over 100 participants enrolled, setting the stage for an interim analysis in January 2026. The company also secured a $13.8 million non-dilutive R&D funding facility to support ongoing development.

Actinogen Medical has locked in up to $13.8 million in non-dilutive funding tied to its R&D tax incentives, bolstering its cash position as it advances a pivotal Alzheimer’s disease clinical trial.

Actinogen Medical has enrolled its 100th participant in the XanaMIA phase 2b/3 Alzheimer’s trial, setting the stage for a critical interim analysis in January 2026 and final results by year-end.

Actinogen Medical advances its XanaMIA phase 2b/3 Alzheimer’s trial with faster patient enrolment and expands clinical sites, while achieving a pivotal FDA meeting outcome for its depression program. The company maintains a strong cash position, supporting ongoing development and commercialization efforts.

Actinogen Medical has published a peer-reviewed article confirming the efficacy of a 10 mg daily dose of Xanamem for treating neurological conditions, reinforcing its ongoing clinical trials in Alzheimer's and depression.

Actinogen Medical accelerates recruitment in its pivotal XanaMIA Alzheimer's trial while securing a strong cash position of $22.9 million, underpinning its late-stage development and commercial readiness.