Anavex Life Sciences Corp. ( AVXL ) shares are tumbling on Wednesday after the company announced it has withdrawn its application for marketing authorization of blarcamesine in the EU for treating early Alzheimer’s disease.

This decision follows feedback from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), which indicated it would not issue a positive opinion at this time.

European Thumbs Down For Anavex Lead Drug

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 feedback received from the CHMP and focus on gathering additional data and conducting further analyses to address the points raised by the CHMP.

In November 2025, EMA’s CHMP adopted a negative trend vote for blarcamesine.

In December, CHMP adopted a negative opinion on the marketing authorization application for blarcamesine.

Anavex requested from the EMA the re-examination in December 2025.

Alzheimer's Program Update

During a Type C meeting with the U.S. Food and Drug Administration (FDA) in January, Anavex Life Sciences ( AVXL ) discussed the potential pathways to support an NDA (New Drug Application) for Alzheimer's disease.

The company provided information related to the scientific rationale and profile of blarcamesine as an oral administration, being convenient to dispense, and the absence of significant safety concerns in clinical trials of blarcamesine conducted so far, extending to the lack of amyloid-related imaging abnormalities.

AVXL Stock Price Activity: Anavex Life Sciences ( AVXL ) shares were down 32.69% at $2.82 at the time of publication on Wednesday. The stock is trading at a new 52-week low, according to Benzinga Pro data.

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