Actinogen Medical (ASX: ACW) has announced that an agreement with the FDA has been reached in a scheduled Type C meeting on the manufacturing, clinical, and nonclinical activities required for a future US marketing approval of Xanamem for Alzheimer’s disease (AD).
According to Actinogen, a similar meeting for AD will be held with the European Medicines Agency in 2026, and subsequently with the UK MHRA and other regulators.
In a statement, Dr. Steven Gourlay, CEO and Managing Director of Actinogen, commented, “We are pleased with the clear guidance from the FDA that confirms our plans for streamlined development of Xanamem in AD. Importantly, the agency agreed with our approach for only one additional, pivotal trial using a single 10 mg Xanamem dose design vs. placebo to support a marketing application for AD in the US.”
