Anavex（AVXL）获FDA放行脆性X综合征IND，可启动blarcamesine 2a期试验，但属预期内程序性进展

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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):
October
15, 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:
☐
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
The 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 October 15, 2026, Anavex Life Sciences Corp. (the “Company”)
issued a press release announcing that it received notification from the U.S. Food and Drug Administration that the Company may proceed
with its planned clinical study under its investigational new drug application for blarcamesine in Fragile X syndrome. A copy of the press
release is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference into this Item 8.01.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit No.
Description
99.1
Press Release dated October 15, 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/ Sandra Boenisch
Name: Sandra Boenisch, CPA, CGA
Title: Principal Financial Officer, Treasurer
Date: October 15, 2026

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EX-99.1
2
e8009_ex99-1.htm
EXHIBIT 99.1
EXHIBIT 99.1
Anavex Receives FDA Clearance of its IND Application
for Blarcamesine in Fragile X Syndrome
Anavex now has open INDs in all three core indications:
Alzheimer’s disease, Rett syndrome, and Fragile X syndrome
Phase 2a study will evaluate the safety, tolerability
and pharmacokinetics of blarcamesine oral solution in adult males with Fragile X syndrome
NEW YORK, NY, October 15, 2026 – Anavex Life Sciences Corp.
(“Anavex” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative treatments
for central nervous system diseases with significant unmet medical needs, today announced that it has received notification from the U.S.
Food and Drug Administration (FDA) that the Company may proceed with its planned clinical study under its Investigational New Drug Application
(IND) for
ANAVEX®2-73
(blarcamesine) for Fragile X syndrome (FXS), a genetic condition that is the most common inherited cause
of intellectual disability and developmental delay and the most commonly known single-gene cause of autism, for which no FDA-approved
treatment currently exists. The IND is now open, enabling clinical investigation of blarcamesine in FXS in the United States. Blarcamesine
has previously received Orphan Drug Designation from the FDA for the treatment of Fragile X syndrome.
“FDA clearance of the Fragile X IND is an important milestone that
gives Anavex open INDs in all three of our core indications: Alzheimer’s Disease, Rett syndrome, and Fragile X syndrome, and supports
our continued momentum of working closely with the FDA as we move our programs forward,” stated Terrie Kellmeyer, Ph.D., Interim
Chief Executive Officer. “With an open IND, we are positioned to advance ANAVEX2-73-FXS-001, a planned Phase 2a randomized, double-blind,
placebo-controlled, dose-ranging study of the safety, tolerability, and pharmacokinetics of blarcamesine oral solution in approximately
60 adult males with FXS, with behavioral (Aberrant Behavior Checklist revised for FXS “ABC
FX
”) and cognitive (NIH
Toolbox) measures included as secondary endpoints. We believe blarcamesine’s differentiated mechanism of action, including its targeting
of sigma-1 receptors, uniquely positions Anavex with the potential to pioneer a transformative treatment approach for patients and families
affected by Fragile X syndrome. Newly published peer-reviewed data in
Frontiers in Pharmacology
further strengthen the scientific
rationale for this program.”
ANAVEX®2-73 (blarcamesine) has been evaluated in the
Fmr1
knockout
mouse model of Fragile X syndrome in three peer-reviewed publications,
Scientific Reports
[i]
, the
American Journal
of Medical Genetics
[ii]
and most recently
Frontiers in Pharmacology
[iii]
.
New Publication in
Frontiers in Pharmacology
The peer-reviewed study, “Blarcamesine improves EEG biomarkers of
cortical dysfunction in a mouse model of Fragile X syndrome” published in
Frontiers in Pharmacology
in September 2026, extends
the preliminary data Anavex reported in 2024. 14 days of oral blarcamesine produced dose-related improvement in EEG abnormalities, including
elevated resting gamma power and impaired synchronization to auditory stimulation, which are shared between the mouse model and individuals
with FXS. These EEG biomarker findings support a translational bridge from preclinical research to clinical development in individuals
with FXS.
Blarcamesine is an investigational drug that has not been approved by the
FDA or any other regulatory authority for any indication, and its safety and efficacy in Fragile X syndrome have not been established.
About Fragile X Syndrome
Fragile X syndrome is a genetic disorder caused by a mutation in the
Fmr1
gene located on the X chromosome. This mutation disrupts the production of a protein called FMRP, which is essential for normal brain
development and functioning. As a result, individuals with FXS experience a range of cognitive, behavioral, and physical challenges. FXS
typically manifests in early childhood, with delayed speech and motor milestones being some of the first noticeable signs. The condition
affects both males and females, but males often experience more severe symptoms due to the single X chromosome. While there is no cure
for Fragile X syndrome, early intervention and tailored support can help improve outcomes for individuals and their families. An estimated
1 in 7,000 males and 1 in 11,000 females have been diagnosed with FXS. Based on available prevalence estimates, the number of affected
individuals could range from approximately 38,000 to 87,000 in the United States and from approximately 777,000 to 1.4 million worldwide
(National Fragile X Foundation, 2026).
About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded clinical
stage biopharmaceutical company engaged in the development of novel therapeutics for the treatment of central nervous system diseases
with high unmet medical need. Further information is available at www.anavex.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning
of the Private Securities Litigation Reform Act of 1995. Statements that are not historical facts, including statements regarding the
impact of the FDA’s clearance of the Company’s IND application for blarcamesine in Fragile X syndrome, the Company’s
clinical trial plans, including the design and timing of the planned Phase 2a study, preclinical data, clinical development programs business
prospects, blarcamesine’s potential, and the timing of site activation and enrollment, are forward-looking statements. These statements
can be identified by the use of forward-looking terminology, including the words “believes,” “anticipates,” “plans,”
“estimates,” “expects,” “intends,” “may,” “will,” “would,” “could”
and similar expressions, or the negative thereof. Many factors may cause actual results to differ materially from those projected in any
of such forward-looking statements, including the risk that preclinical results may not be predictive of results in humans; the risk that
the Phase 2a study may not be initiated, enrolled or completed on the anticipated timeline or at all, including due to delays in site
activation, institutional review board approvals, or patient recruitment; the risk that blarcamesine may not demonstrate an acceptable
safety or tolerability profile, or evidence of efficacy, in Fragile X syndrome; the risk that regulatory authorities may disagree with
the Company’s interpretation of its data; as well as the risks and uncertainties set forth under the heading “Risk Factors”
in the Company’s Annual Report on Form 10-K for the fiscal year ended September 30, 2025, filed with the Securities and Exchange
Commission (“SEC”) on November 25, 2025, the Company’s Quarterly Report on Form 10-Q for the quarterly period ended
December 31, 2025, filed with the SEC on February 9, 2026, the Company’s Annual Report on Form 10-K/A for the fiscal year ended
September 30, 2025, filed with the SEC on August 28, 2026, the Company’s Quarterly Report on Form 10-Q/A for the quarterly period
ended December 31, 2025, filed with the SEC on August 28, 2026, the Company’s Quarterly Report on Form 10-Q for the quarterly period
ended March 31, 2026, filed with the SEC on August 28, 2026, the Company’s Quarterly Report on Form 10-Q for the quarterly period
ended June 30, 2026, filed with the SEC on August 28, 2026, and subsequent filings and furnishings with the SEC, which should be considered
together with any forward-looking statement. 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 except as required by law.
Investor Relations:
SCR Partners, LLC
Alex Arzeno
Tel: 203-550-3972
Email: alex@scr-ir.com
Tripp Sullivan
Tel: 615-942-7077
Email: tsullivan@scr-ir.com
Media:
Sam Brown, LLC
Christy Curran
Tel: 615-414-8668
Email: christycurran@sambrown.com
[i]
Reyes ST, Deacon RMJ, Guo SG, et al. Effects of the sigma-1 receptor agonist blarcamesine in a murine model of Fragile X syndrome: neurobehavioral
phenotypes and receptor occupancy. Sci Rep. 2021;11(1):17150. Published 2021 Aug 25. doi:10.1038/s41598-021-94079-7
[ii]
Cogram P, Deacon RMJ, Klamer D, et al. Brain cell signaling abnormalities are detected in blood in a murine model of Fragile X syndrome
and corrected by Sigma-1 receptor agonist Blarcamesine. Am J Med Genet A. 2022;188(8):2497-2500. doi:10.1002/ajmg.a.62853
[iii]
Jonak CR, Assad SA, Binder DK, et al. Blarcamesine improves EEG biomarkers of cortical dysfunction in a mouse model of Fragile X syndrome.
Front Pharmacol. 2026;17:1786406. Published 2026 Sep 16. Doi:10.3389/fphar.2026.1786406