NEW YORK – January 6, 2026
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 the U.S. Food and Drug Administration (FDA) invited the Company to present its Alzheimer’s disease clinical trial results, reflecting the Agency’s interest in the progress of Anavex’s clinical development efforts.
During the Type C meeting, the FDA expressed interest in and a collaborative approach toward Anavex’s development plans. The Company presented information related to the scientific rationale and profile of blarcamesine as an orally administered therapy, highlighting its convenience of administration and the absence of significant safety concerns observed in clinical trials to date, including the lack of amyloid-related imaging abnormalities (ARIA). Blarcamesine is designed to enhance autophagy through SIGMAR1 activation, supporting cellular homeostasis.
The meeting addressed potential pathways to support a New Drug Application (NDA) for the treatment of Alzheimer’s disease. To advance this process, the Company will submit existing data from the Phase IIb/III ANAVEX2-73-AD-004 program as requested by the Agency. Anavex committed to continuing its constructive dialogue with the FDA to facilitate timely evaluation and advance its Alzheimer’s disease program.
Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex, commented: “We are encouraged by the FDA’s constructive feedback and interest in our Alzheimer’s disease program. This collaborative dialogue reinforces our commitment to advancing innovative therapies for neurodegenerative diseases and positions us well for the next phase of regulatory interactions.”
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 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