Full Press Release Details
Anavex Life Sciences Provides Regulatory
Update on Blarcamesine for Early Alzheimer's Disease
Company plans to request re-examination
after CHMP opinion feedback following its oral explanation
FDA advises Company to meet and
discuss Company's Alzheimer's Disease clinical trial results
NEW YORK - November 14, 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 provides a regulatory update on blarcamesine
for early Alzheimer's disease.
The Company was informed by the Committee for Medicinal
Products for Human Use (CHMP) of the European Medicines Agency (EMA) of a negative trend vote on the Marketing Authorisation Application
(MAA) for blarcamesine following its CHMP oral explanation. The CHMP is expected to adopt a formal opinion on the MAA at its December
meeting. The Company intends to request a re-examination of the CHMP opinion upon its formal adoption, including providing relevant biomarker
data, based on feedback and continued guidance from the CHMP, EMA and the Alzheimer's disease community. The EMA procedures adopted
by the CHMP allow an applicant to request re-examination of its decision, which would be undertaken by a different set of reviewers that
conduct a new examination, independent from the first opinion.
In addition, after initial dialogue, the U.S. FDA's
Center for Drug Evaluation and Research (CDER) advised the Company to request a meeting to discuss the Company's Alzheimer's disease
clinical trial results.
"We appreciate the opportunity for a productive
dialogue and a meaningful exchange during the oral explanation meeting with the CHMP. The discussion provided valuable education and engagement
around our oral blarcamesine early Alzheimer's disease program, which merits continuation," said Juan Carlos Lopez-Talavera,
MD, PhD, Head of Research and Development of Anavex. "We are looking forward to working closely with the EMA and other stakeholders
to advance our investigational therapy for early Alzheimer's disease, to define the optimal regulatory path forward."
"Resounding voices from Alzheimer's patients
and caregivers makes it clear that new practicable treatment options are needed for early Alzheimer's disease. Oral blarcamesine
could represent a novel treatment opportunity in early Alzheimer's disease," said Marwan Noel Sabbagh, MD, Professor of Neurology,
and Chairman of the Anavex Scientific Advisory Board. "Coupled with a strong safety profile and no need for routine MRI monitoring,
oral blarcamesine's unique mechanism of action would also support a Precision Medicine approach."
"There is a growing unmet medical need for implementable
and service-ready options for early Alzheimer's disease patients, coupled with enhanced quality of life and a strong safety profile,"
said Prof. Dr. Timo Grimmer, MD, member of the Anavex Scientific Advisory Board and National Coordinating Investigator for the blarcamesine
Phase IIb/III ANAVEX 2-73-AD-004 study. "Blarcamesine's precision-based approach holds great promise to substantially
alleviate both the medical and economic impact of this disease."
"We believe that the initiated dialogue reinforced
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 is committed to continue working in partnership with global regulatory bodies in
order to advance science and potentially new 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 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, ANAVEX 2-73 (blarcamesine), 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. ANAVEX 2-73
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. ANAVEX 2-73 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 ANAVEX 2-73 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
Email: andrew@barwicki.com