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Item 8.01 Other Events.
On November 14, 2025, Anavex Life Sciences Corp. (the “Company”) issued a press release announcing that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has rendered a negative trend vote following an oral explanation of the Company’s Marketing Authorization Application (MAA) for blarcamesine.
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.
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. |
| EXHIBIT NO. | DESCRIPTION | LOCATION | ||
| 99.1 | Press release dated November 14, 2025 | Filed herewith | ||
| 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. | ||
| By: | /s/ Christopher Missling | |
| Name: Christopher Missling, PhD |
||
| Title: Chief Executive Officer | ||
Date: November 14, 2025