NEW YORK – December 18, 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 announced that it has requested the European Medicines Agency (EMA) to re-examine its opinion on blarcamesine for the treatment of early Alzheimer’s disease.
Anavex has requested the re-examination from the EMA and will work closely with the Agency throughout the process. The re-examination procedure will be led by a different rapporteur and co-rapporteur, who will conduct a new evaluation of the Company’s marketing authorization application for blarcamesine. Anavex has also requested that the EMA consult a Scientific Advisory Group as part of this process to provide an independent recommendation.
“There is a significant unmet need for new innovative oral treatment options that target disease pathology upstream by restoring autophagy,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “Alzheimer’s disease poses substantial challenges for people living with the disease, their care partners, and society. 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