What is Anavex's strategy to address the European Medicines Agency's negative trend vote on blarcamesine's Marketing Authorisation Application?

Anavex Life Sciences plans to request a re-examination of the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) negative trend vote on the Marketing Authorisation Application (MAA) for blarcamesine. The company received notification of this negative trend vote on November 14, 2025, following an oral explanation to the CHMP.1

Upon the formal adoption of the CHMP's opinion, Anavex intends to initiate the re-examination process.1 This strategy will involve providing relevant biomarker data, taking into account feedback and continued guidance from the CHMP, the EMA, and the broader Alzheimer's disease community.2 EMA procedures allow for such a re-examination, where a different set of reviewers conducts a new, independent assessment of the application.2 Anavex has expressed its commitment to working with the EMA to define the optimal regulatory path forward for blarcamesine.2