Anavex Life Sciences Corp. (NASDAQ: AVXL) withdrew its marketing authorization application for blarcamesine as an add-on therapy for early Alzheimer's disease in the European Union. The company made the announcement following feedback from the European Medicines Agency's Committee for Medicinal Products for Human Use indicating it would not issue a positive opinion for the application.

The biopharmaceutical company had submitted the application after receiving encouragement from the EMA's SME Office in October 2023. At that time, EMA representatives had encouraged Anavex to "immediately begin preparing" for the application and indicated that applying for marketing authorization would be the next step for the company.

Anavex plans to consider the feedback received from the committee and focus on gathering additional data and conducting further analyses to address the points raised by the regulatory body. The company stated it remains committed to the ongoing clinical development of blarcamesine for patients with early Alzheimer's disease.

"We remain dedicated to advancing the development of innovative oral therapies for patients living with early Alzheimer's disease and to continuing our engagement with regulatory authorities," said Christopher U. Missling, the company's president and chief executive officer.

Blarcamesine is an oral drug candidate designed to target SIGMAR1 and muscarinic receptors. The company has completed Phase 2a and Phase 2b/3 clinical trials for Alzheimer's disease, as well as studies for Parkinson's disease dementia and Rett syndrome. Anavex develops treatments for neurodegenerative, neurodevelopmental, and neuropsychiatric disorders.