Anavex Life Sciences Corp. has formally asked the European Medicines Agency to re‑examine its December 11, 2025 negative opinion on the marketing authorization application for blarcamesine, the company’s lead Alzheimer’s disease candidate. The request, filed under a new rapporteur and co‑rapporteur, also calls for the EMA to convene a Scientific Advisory Group to provide an independent recommendation.
The December 11 decision was based on several concerns: the pivotal Phase 2b/3 study failed to demonstrate effectiveness and safety of blarcamesine in early Alzheimer’s patients without a SIGMAR1 mutation; the company’s statistical analysis was deemed methodologically flawed; and the study could not rule out the formation of nitrosamine impurities, raising safety questions.
Anavex had a 15‑day window to submit the re‑examination request after receiving the negative opinion. The company filed its request on December 18, 2025, and has requested a fresh evaluation of the MAA, signaling its intent to address the EMA’s concerns and pursue approval in the European Union.
Financially, Anavex reported a Q4 2025 net loss of $9.8 million, or $0.11 per share, and a diluted EPS of –$0.54 for the year. The company has no revenue, no debt, and a robust current ratio of 11.6, underscoring its liquidity position as it navigates the regulatory process.
The company’s stock has declined 56% over the past six months, trading within a 52‑week range of $2.86 to $14.44. CEO Christopher U. Missling emphasized the unmet need for oral Alzheimer’s treatments that target upstream pathology and reiterated Anavex’s commitment to working closely with regulators to bring new options to patients.
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