Press release
Anavex Life Sciences Submitted Request for EMA to Re-Examine Its Opinion
NEW YORK, Dec. 18, 2025 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company
About this update from Anavex Life Sciences Corp.
[{"type":"text","content":"NEW YORK, Dec. 18, 2025 (GLOBE NEWSWIRE) -- 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 from the EMA the re-examination, and will work closely with the EMA during this process. The re-examination procedure is led by a different rapporteur and co-rapporteur, who will conduct a new evaluation of our 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 the pathology upstream by restoring autophagy,” said Christopher U Missling, PhD, President and Chief Executive Officer of Anavex. “Alzheimer's disease is a neurodegenerative disease that poses significant challenges to those living with Alzheimer's, their care partners and society and our team is committed to continue working in partnership with regulatory bodies in order to advance science and potentially 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 a progressive disease, where symptoms gradually worsen over time. Each stage of the disease presents different challenges for those living with the disease and their care partners. There is a significant unmet need for new treatment options that can ...