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

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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.

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