Anavex Life Sciences Corp. (NASDAQ: AVXL) withdrew its application for marketing authorization of blarcamesine in the European Union for early Alzheimer's disease treatment, the company announced.

The biopharmaceutical company said it continues dialogue with the European Medicines Agency to address points raised by the Committee for Medicinal Products for Human Use. Anavex plans to gather additional data and conduct further analyses to advance the development program.

The company submitted additional data to the U.S. Food and Drug Administration seeking alignment on the Alzheimer's disease development program for blarcamesine in the United States. The objective is to discuss potential pathways toward a New Drug Application for early Alzheimer's disease treatment.

Anavex also engaged in discussions with EU regulators regarding blarcamesine for Parkinson's disease and rare diseases, including Rett syndrome.

"We remain committed about advancing the development of innovative oral therapies for patients living with both neurodegenerative diseases, including early Alzheimer's and Parkinson's disease and neurodevelopmental disorders as we continue our engagement with regulatory authorities," said Christopher U. Missling, the company's president and chief executive officer.

Blarcamesine has completed Phase 2a and Phase 2b/3 clinical trials for Alzheimer's disease, a Phase 2 study in Parkinson's disease dementia, and Phase 2 and Phase 3 studies in adult patients with Rett syndrome, plus one Phase 2/3 study in pediatric patients with Rett syndrome.

The oral drug candidate targets SIGMAR1 and muscarinic receptors and is designed to restore cellular homeostasis. Anavex focuses on developing treatments for neurodegenerative, neurodevelopmental and neuropsychiatric disorders.