Anavex dips amid oral hearing scheduled for lead drug in EU

[An arrow pointing downwards on top of a pile of US dollar bills.]

* Shares of Anavex Life Sciences (AVXL [https://seekingalpha.com/symbol/AVXL]) fell as much as ~9% on Monday after the EU drug regulator, the European Medicines Agency (EMA), selected the company for an oral explanation regarding its lead drug ANAVEX 2-73 (blarcamesine).
* The hearing about blarcamesine’s use in Alzheimer’s disease and dementia is scheduled for Nov. 11 before the EMA’s Committee for Medicinal Products [https://www.ema.europa.eu/en/documents/agenda/agenda-chmp-meeting-10-13-november-2025_en.pdf] for Human Use (CHMP), according to this week’s CHMP meeting agenda released on Monday.
* In December 2024, EMA accepted the New York-based biotech’s Marketing Authorization Application for ANAVEX 2-73, targeted at Alzheimer’s disease, for review as part of the agency’s centralized procedure.
* The MAA was backed by data from a randomized, double-blind, placebo-controlled Phase 2b/3 clinical trial for the once-daily oral molecule in early Alzheimer’s disease and its open-label extension spanning up to 144 weeks. [https://seekingalpha.com/news/4390016-anavex-stock-rallies-30-on-business-updates]

MORE ON ANAVEX LIFE SCIENCES

* Anavex Life Sciences: Inching Closer To Binary Regulatory Outcome In The EU [https://seekingalpha.com/article/4837487-anavex-life-sciences-inching-closer-to-binary-regulatory-outcome-in-the-eu]
* Anavex: ANAVEX 3-71 Could Potentially Offer Disease-Modifying Effects For Schizophrenia [https://seekingalpha.com/article/4827519-anavex-could-potentially-offer-disease-modifying-effects-for-schizophrenia]
* Anavex: As The EMA Decision Nears, Key Risks Outweigh The Hype [https://seekingalpha.com/article/4812997-anavex-as-the-ema-decision-nears-key-risks-outweigh-the-hype]
* Anavex rises after trial data for schizophrenia candidate (update) [https://seekingalpha.com/news/4501217-anavex-posts-trial-data-schizophrenia-drug]
* Seeking Alpha’s Quant Rating on Anavex Life Sciences [https://seekingalpha.com/symbol/AVXL/ratings/quant-ratings]