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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): March
25, 2026
ANAVEX LIFE SCIENCES CORP.
(Exact name of registrant as specified in its charter)
| Nevada |
001-37606 |
98-0608404 |
| (State or other jurisdiction |
(Commission |
(IRS Employer |
| of incorporation) |
File Number) |
Identification No.) |
630 5th Avenue, 20th Floor, New York, NY
USA 10111
(Address of principal executive offices) (Zip Code)
1-844-689-3939
Registrant’s telephone number, including area
code
Check the appropriate box below if the Form 8-K filing
is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction
A.2. below):
☐ Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐ Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a -12)
☐ Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d -2(b))
☐ Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e -4(c))
Securities registered pursuant to Section 12(b) of
the Act:
| Title of Each Class |
|
Trading Symbol(s) |
|
Name of Each Exchange on which Registered |
| Common Stock, par value $0.001 per share |
|
AVXL |
|
Nasdaq Stock Market LLC |
Indicate by check mark whether the registrant is an
emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities
Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark
if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards
provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 8.01. Other Events.
On March 25, 2026, Anavex Life Sciences Corp. (the “Company”)
issued a press release announcing that it has withdrawn its application for the marketing authorization of blarcamesine in the EU as an
add-on therapy for the treatment of early Alzheimer’s disease in adults, which had been under review by the European Medicines Agency
(EMA).
A copy of the press release is furnished as Exhibit
99.1 and is incorporated herein by reference, including the cautionary statement on forward-looking statements included in the press release.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
| 99.1 |
|
Press Release of the Company dated March 25, 2026 |
| 104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURES
Pursuant to the requirements of
the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
| |
ANAVEX LIFE SCIENCES CORP. |
| |
|
| |
/s/ Christopher Missling |
| |
Name: |
Christopher Missling, PhD |
| |
Title: |
Chief Executive Officer |
| |
|
| Date: March 25, 2026 |
|
EXHIBIT 99.1
Anavex Life Sciences Provides Update
on Regulatory Review in the EU for Blarcamesine to Treat Early Alzheimer’s Disease
NEW YORK – March 25, 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 it has withdrawn its
application for the marketing authorization of blarcamesine in the EU as an add-on therapy for the treatment of early Alzheimer’s
disease in adults, which had been under review by the European Medicines Agency (EMA).
The decision to withdraw the application follows feedback
from the EMA’s Committee for Medicinal Products for Human Use (CHMP) indicating that it would not be in a position to issue a positive
opinion for the application at this time. The Company remains committed to the ongoing clinical development of blarcamesine and to advancing
potential therapeutic options addressing the significant unmet medical needs of patients living with early Alzheimer’s disease,
also motivated by the strong support received by Alzheimer’s disease patients and organizations, including Alzheimer Europe.
Anavex had submitted the application following encouragement
by the SME Office of the EMA in October 2023 when the EMA representatives encouraged Anavex “to immediately begin preparing”
for the application and that the “next step for Anavex in terms of interactions with EMA would be to apply for a marketing authorization
application.” Anavex now has to take note of the differing assessment of the CHMP at the EMA and will consider the constructive
feedback received from the CHMP and focus on gathering additional data and conducting further analyses to address the points raised by
the CHMP.
“We remain dedicated to advancing the development
of innovative oral therapies for patients living with early Alzheimer’s disease and to continuing 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 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 slow down the progression of Alzheimer’s disease and reduce the overall burden on
people affected and on 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 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
