Anavex Life Sciences Corp. ("Anavex" or the "Company") (NASDAQ:AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, today announced that it has withdrawn its application for the marketing authorization of blarcamesine in the EU as an add-on therapy for the treatment of early Alzheimer's disease in adults, which had been under review by the European Medicines Agency (EMA).

The decision to withdraw the application follows feedback from the EMA's Committee for Medicinal Products for Human Use (CHMP) indicating that it would not be in a position to issue a positive opinion for the application at this time. The Company remains committed to the ongoing clinical development of blarcamesine and to advancing potential therapeutic options addressing the significant unmet medical needs of patients living with early Alzheimer's disease, also motivated by the strong support received by Alzheimer's disease patients and organizations, including Alzheimer Europe.

Anavex had submitted the application following encouragement by the SME Office of the EMA in October 2023 when the EMA representatives encouraged Anavex "to immediately begin preparing" for the application and that the "next step for Anavex in terms of interactions with EMA would be to apply for a marketing authorization application." Anavex now has to take note of the differing assessment of the CHMP at the EMA and will consider the constructive feedback received from the CHMP and focus on gathering additional data and conducting further analyses to address the points raised by the CHMP.