Actinogen achieves agreement with the FDA in a Type C meeting on the manufacturing, clinical and nonclinical activities required for a future US marketing approval of Xanamem for Alzheimer’s disease
Globenewswire·2025-09-15 20:30
Current XanaMIA pivotal phase 2/3 trial on track for interim analysis in January 2026 and final results late 2026 with trial enrolment expected to close in Q4 2025SYDNEY, Sept. 15, 2025 (GLOBE NEWSWIRE) -- Actinogen Medical Limited (ASX: ACW) announces the successful conduct of its scheduled Type C meeting (written response) on Alzheimer’s disease (AD) with the US Food & Drug Administration (FDA). Actinogen and the FDA reached a common understanding of the pathway to marketing approval in AD - meaning agree ...