Anavex Life Sciences Corp (AVXL)

[12x]

The EMA likely referenced the subgroup findings from Pridopidine’s Phase 3 PROOF-HD trial—where functional benefit was observed in patients not taking antidopaminergic medications. However, even in this subgroup, the primary endpoint was not met—only a secondary endpoint showed statistical significance:
🔗 https://practicalneurology.com/news/proof-hd-trial-results-show-benefits-of-pridopidine-as-huntington-disease-treatment-in-those-not-taking-adms/2474032/?utm_source=chatgpt.com

Overall, the EMA’s refusal of Sigma-1 based Pridopidine has mild negative (ChatGPT now has the MAA approval probability at 55%) implications for Blarcamesine in two ways:

It confirms that a drug can pass Day 120 (Clock Stop 1) and still be rejected—a positive early regulatory signal doesn’t guarantee approval, especially if the pivotal trial failed its primary endpoint or efficacy is limited to subgroups.

As the first Sigma-1 receptor drug reviewed by EMA, Pridopidine’s Clock 1 pass enabled Prilenia to secure a €500M partnership with Ferrer. Now, with CHMP issuing a refusal, it casts doubt on whether AVXL can land a major EU partnership before CHMP renders its final decision.
🔗 https://news.prilenia.com/press-releases/press-release-details/2025/Prilenia-Enters-into-a-Collaboration-and-License-Agreement-with-Ferrer-for-the-Commercialization-and-Co-Development-of-Pridopidine-in-Europe-and-Other-Select-Markets/default.aspx

That said, Blarcamesine has a much stronger case—it met one co-primary and the secondary endpoint, with strong OLE support.