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Asia

Actinogen Medical Receives Independent DMC Positive Recommendation for Phase 2b/3 Alzheimer's Disease Trial, Shares Jump 10%

Actinogen Medical (ASX:ACW) received a positive recommendation from the XanaMIA phase 2b/3 Alzheimer's disease trial's independent data monitoring committee (DMC) to continue the trial without amendment, according to a Thursday Australian bourse filing.The committee comprises independent clinical and statistical experts who are not connected to the day-to-day conduct or analysis of the trial.The primary endpoint of the trial is the internationally recognized Clinical Dementia Rating scale-Sum of Boxes. Oral Xanamem 10 milligrams daily doses continue to demonstrate a promising safety profile in patients with mild to moderate Alzheimer's disease treated for up to 36 weeks in the trial, it added.Its shares jumped 10% in recent trading on Thursday.

ASX:ACW
Asia

Actinogen Medical Reaches Common Understanding With European Regulator on Pathway to Marketing Approval for Alzheimers' Disease Program

Actinogen Medical (ASX:ACW) reached a common understanding of the pathway to marketing approval for its Alzheimer's disease program in its scheduled scientific advice meeting with the European Medicines Agency (EMA), according to a Thursday Australian bourse filing.The understanding includes the specification of regulatory starting materials for the commercial manufacturing of Xanamem (emestedastat) drug substance, design considerations for an additional pivotal clinical trial, as well as the limited number of ancillary clinical pharmacology trials and nonclinical studies required.The understandings also include ensuring the proposed makeup of the planned safety database is consistent with EMA and US Food and Drug Administration (FDA) guidelines.The firm said the understandings align closely with the guidance received at an earlier meeting with the US FDA's Neurology-I division.Actinogen Medical's shares rose nearly 3% in recent trading on Thursday.

ASX:ACW

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