Dialogue continues with European Medicines Agency (EMA) to advance the development program of oral blarcamesine in early Alzheimer's disease
Additional data submitted to the U.S. FDA with the objective to discuss potential pathways towards a New Drug Application (NDA) for the treatment of early Alzheimer's disease
Additionally, Anavex has engaged in discussions with EU regulators regarding blarcamesine for Parkinson's disease and rare diseases, including Rett syndrome
NEW YORK, March 30, 2026 (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 provides a comprehensive regulatory update.
Following the withdrawal of the application for the marketing authorization of blarcamesine in the EU, Anavex will continue to gather additional data and conduct further analyses to advance the development program in early Alzheimer's disease. The dialogue continues with the EMA to address the points raised by the Committee for Medicinal Products for Human Use (CHMP).
As part of our ongoing interactions with the FDA, Anavex has submitted additional data to the regulatory agency with the objective of reaching alignment on the Alzheimer's disease development program for blarcamesine in the U.S.
Anavex is also advancing regulatory engagement with EU authorities for blarcamesine in Parkinson's disease and rare neurological conditions, including Rett syndrome, underscoring the breadth of the Company's clinical development portfolio.
"We remain committed about advancing the development of innovative oral therapies for patients living with both neurodegenerative diseases, including early Alzheimer's and Parkinson's disease and neurodevelopmental disorders as we continue our engagement with regulatory authorities," said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex.
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 Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative, neurodevelopmental, and neuropsychiatric disorders, including Alzheimer's disease, Parkinson's disease, schizophrenia, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex's lead drug candidate, blarcamesine (ANAVEX®2-73), has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer's disease, a Phase 2 proof-of-concept study in Parkinson's disease dementia, and both a Phase 2 and a Phase 3 study in adult patients and one Phase 2/3 study in pediatric patients with Rett syndrome. Blarcamesine is an orally available drug candidate designed to restore cellular homeostasis by targeting SIGMAR1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer's disease. Blarcamesine also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson's Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop blarcamesine for the treatment of Parkinson's disease. We believe that ANAVEX®3-71, which targets SIGMAR1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer's disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at www.anavex.com. You can also connect with the Company on Twitter, Facebook, Instagram, and LinkedIn.
Forward-Looking Statements
Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company's most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after 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
