Question · Q4 2025
Michael Obadiah asked about the potential commercial impact of semaglutide's failure on Blarcamesine in Alzheimer's disease, the timeline for the next formal discussion of Blarcamesine with the FDA, and Anavex's near-term initiatives for Blarcamesine approval in regions beyond the European Union and the United States.
Answer
President and CEO Christopher Missling explained that semaglutide's setback underscores the complexity of Alzheimer's and the unmet medical need. He highlighted Blarcamesine's upstream mechanism, which restores autophagy, and its clinically meaningful efficacy in slowing cognitive decline (over 50% in some cases) with an acceptable safety profile (no ARIA) in the phase 2b/3 study. Regarding the FDA, he stated that updates on initial discussions would be provided as they become available. For global approvals, Anavex is exploring other regulatory geographies and addressing open questions.
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