AVXL · Anavex Life Sciences Corp.

Summary

Anavex Life Sciences Corp. withdrew its application for marketing authorization of blarcamesine in the EU as an add-on therapy for early Alzheimer’s disease in adults, following EMA CHMP feedback indicating no positive opinion. The company plans to gather additional data based on CHMP feedback while remaining committed to blarcamesine’s development.

Key takeaways

• Withdrew EU MAA for blarcamesine on March 25, 2026
• Application under review by European Medicines Agency (EMA)
• EMA CHMP indicated it would not issue positive opinion
• Submitted following EMA SME Office encouragement in October 2023
• Will conduct further analyses to address CHMP points
• CEO Christopher U. Missling stated dedication to advancing oral therapies for early Alzheimer’s