Anavex stock plummets after negative CHMP vote on Alzheimer’s drug

Investing.com -- Anavex Life Sciences Corp. (NASDAQ:AVXL) stock plummeted 50% after the company received a negative trend vote from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on its Alzheimer’s disease drug candidate blarcamesine.

The clinical-stage biopharmaceutical company disclosed that the CHMP is expected to adopt a formal opinion on the Marketing Authorisation Application at its December meeting. Anavex intends to request a re-examination of the decision once formally adopted, which would be conducted by a different set of reviewers.

In parallel developments, Anavex reported that the U.S. Food and Drug Administration has advised the company to request a meeting to discuss its Alzheimer’s disease clinical trial results, suggesting ongoing dialogue with U.S. regulators.

"We appreciate the opportunity for a productive dialogue and a meaningful exchange during the oral explanation meeting with the CHMP. The discussion provided valuable education and engagement around our oral blarcamesine early Alzheimer’s disease program, which merits continuation," said Juan Carlos Lopez-Talavera, MD, PhD, Head of Research and Development at Anavex.

The company emphasized that blarcamesine could represent a novel treatment option for early Alzheimer’s disease patients, highlighting its oral administration, unique mechanism of action, and safety profile that reportedly doesn’t require routine MRI monitoring.

Anavex is also developing treatments for other central nervous system disorders, including Parkinson’s disease, schizophrenia, and Rett syndrome.

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