Anavex 宣布 blarcamesine 两项临床药理学研究（ADME/DDI）完成入组与临床执行，无疗效数据

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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
20, 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 20, 2026, Anavex Life Sciences Corp. (the “Company”)
issued a press release providing an update on the clinical development of blarcamesine (ANAVEX
®
2-73), including the completion
of the clinical conduct of two pharmacology studies: (i) an ADME (absorption, distribution, metabolism and excretion) study and (ii) a
DDI (drug-drug interaction) study. 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 20, 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 20, 2026

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EX-99.1
2
e8011_ex99-1.htm
EXHIBIT 99.1
EXHIBIT 99.1
Anavex Provides Corporate Update, Announces Completion
of Clinical Conduct of ADME and DDI Clinical Studies
Clinical conduct of both blarcamesine (ANAVEX®2-73)
studies in healthy volunteers is now complete, data are expected to support clinical pharmacology characterization across pipeline programs
NEW YORK, NY, October 20, 2026 – Anavex Life Sciences Corp.
(“Anavex” or the “Company”), a clinical-stage biopharmaceutical company developing innovative treatments for central
nervous system diseases with significant unmet medical needs, today provided a corporate update highlighting progress across its three
core indications for blarcamesine (ANAVEX 2-73): early Alzheimer’s disease, Rett syndrome and Fragile X syndrome. Recent Company
highlights include the completion of clinical conduct of the Drug-drug Interaction (DDI) and Absorption, Distribution, Metabolism and
Excretion (ADME) studies of blarcamesine, clearance by the U.S. Food and Drug Administration (FDA) of the Company’s Investigational
New Drug (IND) application in Fragile X syndrome, and an upcoming meeting with the FDA in November to discuss adding pediatric participants
to the Phase 3 Rett syndrome study.
“Completion of the DDI and ADME studies represents an important milestone
for blarcamesine, advancing the clinical pharmacology data package recommended by the FDA, which we expect to benefit our ongoing core
programs.” said Terrie Kellmeyer, Ph.D., Interim Chief Executive Officer. “Together with the FDA’s recent clearance
of our IND in Fragile X syndrome, these studies reflect positive progress and execution on timelines previously set forth. With these
achievements, we believe that we are well positioned to continue to move forward on our strategic objectives through the remainder of
the year.”
Alzheimer’s Disease
Program
Anavex has completed clinical
conduct of two clinical pharmacology studies of blarcamesine. The studies address clinical pharmacology data recommended by the FDA and
the data are expected to support the Company’s FDA-focused development program. The FDA’s recommendation is aligned with feedback
the Company received from the European Medicines Agency (EMA).
●
DDI
study: The last participant completed the study at the end of September, concluding clinical
conduct.
●
The
study was fully enrolled with 65 participants, all of whom received 30 mg of blarcamesine.
Based on preliminary observations, no serious adverse events were reported. Full safety and
pharmacokinetic data analysis is ongoing.
●
ADME
study: The last participant completed the study in mid-October, concluding clinical conduct.
●
The
study enrolled 8 participants, all of whom received 30 mg of blarcamesine. Based on preliminary
observations, no serious adverse events were reported. Full safety and pharmacokinetic data
analysis is ongoing.
●
Both
studies enrolled healthy volunteers and were designed to further characterize blarcamesine’s
clinical pharmacology profile. Their data are critical for the Alzheimer’s disease
program and are also expected to support development in the Company’s Rett syndrome
and Fragile X syndrome programs.
Rett Syndrome Program
●
The
Company has an FDA-aligned protocol for its Phase 3 study of blarcamesine in Rett syndrome
in adult participants (ANAVEX2-73-RS-005). As previously announced on September 9, 2026,
the FDA granted the Company a meeting to discuss adding pediatric participants to the Phase
3 protocol for November. Blarcamesine for the treatment of Rett syndrome has been granted
Orphan Drug Designation by the FDA. The program remains on track with study start-up activities
underway.
Fragile X Syndrome Program
●
The
Company submitted an (IND application for blarcamesine in Fragile X syndrome in September
2026, and, as
previously
announced
on October 15, 2026, the FDA has cleared the IND.
Blarcamesine for the treatment of Fragile X syndrome has been granted Orphan Drug Designation
by the FDA. Study start-up activities are underway.
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
Company’s clinical trial plans, preclinical and clinical data, clinical development programs and business prospects, blarcamesine’s
potential, the Company’s expectations that the clinical conduct of the ADME and DDI clinical studies will support the Company’s
FDA-focused development program, the Company’s plans to meet with the FDA in November to discuss
adding
pediatric participants to the Phase 3 protocol for blarcamesine in Rett syndrome,
the impact of the FDA’s clearance of the
Company’s IND application for Fragile X syndrome, 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 volatility in the Company’s stock price and the market in general; the Company’s ability to raise additional
capital; challenges seeking, and ultimately obtaining, regulatory approval for the Company’s product candidates; the ability of
Fast Track designation or breakthrough therapy designation to lead to a faster FDA review and approval process; the Company’s ability
to maintain any benefits associated with Orphan Drug Designation, including market exclusivity; undesirable side effects caused by the
Company’s product candidates; the Company’s ability to attract and retain highly qualified personnel; the Company’s
reliance on third-parties; the Company’s ability to obtain and maintain sufficient intellectual property protection for our product
candidates; the Company’s ability to defend against claims of intellectual property infringement; the Company’s ability to
compete in the highly competitive biotechnology and pharmaceutical industries; and other the risks and uncertainties set forth 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 Form 10-K/A for the fiscal year ended September 30, 2025, filed with
the SEC on August 28, 2026, the Company’s 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.
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