Anavex Life Sciences disclosed that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a negative trend vote on its marketing authorization application for blarcamesine, the company’s lead candidate for early Alzheimer’s disease. The vote was issued on November 14 2025 and signals that the committee has identified concerns that must be addressed before a formal opinion can be adopted.
The CHMP is expected to adopt a formal opinion in its December meeting. In response, Anavex will request a re‑examination of the opinion and will submit additional biomarker data that the committee cited as insufficient. The company’s strategy is to demonstrate that the biomarker evidence now meets the regulatory threshold for efficacy and safety.
Anavex is also in dialogue with the U.S. Food and Drug Administration. The FDA has advised the company to schedule a meeting to discuss the results of the Phase 2b/3 trials. The meeting is intended to clarify the data and to explore potential pathways for U.S. approval, but it does not guarantee a positive outcome.
The regulatory setback could delay European approval and affect the company’s commercial timeline. Anavex’s financial statements for the third quarter of fiscal 2025 show a net loss of $13.2 million, up from $12.2 million in the same quarter of fiscal 2024. Research and development expenses fell year‑over‑year, while general and administrative costs rose. The company reported $101.2 million in cash and cash equivalents as of June 30 2025, giving it a runway of more than three years under current burn rates.
Blarcamesine remains the company’s flagship program, having completed Phase 2a and Phase 2b/3 trials that demonstrated sustained benefit in early Alzheimer’s patients. The company also continues development of candidates for Parkinson’s disease, schizophrenia, and Rett syndrome, underscoring its precision‑medicine approach that leverages genomic biomarkers.
Dr. Juan Carlos Lopez‑Talavera, head of research and development, said the CHMP dialogue provided “valuable education and engagement” and that the program “merits continuation.” Dr. Marwan Noel Sabbagh, chairman of the scientific advisory board, emphasized the unmet need for early Alzheimer’s treatments and the potential of blarcamesine to fill that gap.
While the negative trend vote represents a significant regulatory hurdle, Anavex remains committed to advancing its pipeline. The company’s next steps—re‑examination, additional biomarker data, and continued engagement with the FDA—are designed to address the committee’s concerns and to keep the path to market open.
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