NEW YORK – December 12, 2025
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 provided an update on the regulatory review in the European Union for blarcamesine for the treatment of early Alzheimer’s disease.
As previously communicated, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) informed Anavex of a negative trend vote following its oral examination in November. The CHMP has since adopted a negative opinion on the marketing authorization application for blarcamesine to treat Alzheimer’s disease. The Company intends to request a re-examination of the CHMP opinion. Under EMA procedures, such a request would be reviewed by a different set of rapporteurs who will conduct a new and independent evaluation.
“We believe that the initiated dialogue reinforces our shared commitment to addressing the urgent unmet need in Alzheimer’s disease,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “Our team remains committed to working in partnership with regulatory authorities to advance science and potentially deliver new oral treatment options for patients and their families.”
This release discusses investigational uses of an agent in development and is not intended to convey conclusions about efficacy or safety. There is no guarantee that any investigational uses of such product will successfully complete clinical development or gain health authority approval.
About Alzheimer’s Disease
Alzheimer’s disease is the most common cause of dementia, accounting for 60–80% of all dementia cases worldwide. Dementia is a general term for memory loss and other cognitive abilities serious enough to interfere with daily life. Alzheimer’s disease is progressive, with symptoms that worsen over time, presenting increasing challenges for individuals and their care partners. There remains a significant unmet need for new treatment options that can slow disease progression and reduce the overall burden on patients, caregivers, and society.
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for neurodegenerative, neurodevelopmental, and neuropsychiatric disorders, including Alzheimer’s disease, Parkinson’s disease, schizophrenia, Rett syndrome, and other CNS disorders, pain, and certain cancers. The Company’s lead drug candidate, ANAVEX®2-73 (blarcamesine), is an orally available therapy designed to restore cellular homeostasis by targeting SIGMAR1 and muscarinic receptors, including enhancement of autophagy. Further information is available at www.anavex.com.
Forward-Looking Statements
Statements in this press release that are not strictly historical are forward-looking statements based on current expectations and involve risks and uncertainties. Actual results may differ materially from those projected. Readers are cautioned not to place undue reliance on these statements, which speak only as of the date hereof.
For Further Information
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: info@anavex.com
Investors
Andrew J. Barwicki
Investor Relations
Tel: 516-662-9461
Email: andrew@barwicki.com