Actinogen receives positive scientific advice from EMA

• Actinogen received positive scientific advice from EMA
• Agreement on regulatory starting materials for Xanamem
• One additional pivotal phase 3 trial required
• EMA feedback aligns with prior FDA guidance

Actinogen Medical Ltd. (ASX: ACW) announced that it received successful outcomes from its scientific advice meeting with the European Medicines Agency (EMA) regarding its Alzheimer's disease program. The meeting resulted in a common understanding of the pathway to marketing approval, including the suitability of regulatory starting materials, design considerations for an additional pivotal clinical trial, and the number of ancillary trials and studies required. The EMA's feedback aligns closely with the guidance received from the FDA, providing regulatory clarity for ongoing discussions with potential development and marketing partners.