• Successful Type C meeting with FDA on major depressive disorder (MDD)
• Reached common understanding on additional clinical trials and studies required for marketing approval of Xanamem for MDD
• Similar Type C meeting for Alzheimer's disease to be held later in 2025

Actinogen Medical (ASX: ACW) has announced the successful conduct of its scheduled Type C meeting on major depressive disorder (MDD) with the US Food & Drug Administration (FDA). In a collaborative interaction, Actinogen and the FDA reached a common understanding of the additional clinical trials, ancillary clinical pharmacology trials and nonclinical studies required to apply for marketing approval of Xanamem (emestedastat) for MDD in the future. The agreements reached at this meeting with the FDA's Psychiatry Division represent a major accomplishment for Actinogen and will be important in future discussions with potential partners and granting bodies. A similar Type C meeting for Alzheimer's disease (AD) will be held with the FDA's Neurology Division later in 2025. Meanwhile, the Company continues to focus its resources on accelerating the current XanaMIA phase 2b/3 AD trial at Australian and US clinical sites and optimizing trial quality.

The Company continues to focus its resources on accelerating the current XanaMIA phase 2b/3 Alzheimer's disease trial and optimizing trial quality. A similar Type C meeting for Alzheimer's disease will be held with the FDA's Neurology Division later in 2025.