Anavex Life Sciences Corp. (NASDAQ:AVXL) saw its stock plunge by 50% on Friday after revealing that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) delivered a negative trend vote on its Alzheimer’s drug candidate, blarcamesine.
The company said the CHMP is expected to issue a final opinion on the therapy’s Marketing Authorisation Application at its December meeting. Once that opinion is formalized, Anavex plans to request a re-examination—an appeal process that involves evaluation by a separate panel of reviewers.
Separately, Anavex noted that the U.S. Food and Drug Administration has advised the firm to schedule a meeting to further discuss the clinical results from its Alzheimer’s trials, indicating that conversations with American regulators remain active.
“We appreciate the opportunity for a productive dialogue and a meaningful exchange during the oral explanation meeting with the CHMP. The discussion provided valuable education and engagement around our oral blarcamesine early Alzheimer’s disease program, which merits continuation,” said Juan Carlos Lopez-Talavera, MD, PhD, Head of Research and Development at Anavex.
The company reiterated its view that blarcamesine has the potential to become a new therapeutic option for patients in the early stages of Alzheimer’s disease, citing its oral dosing, differentiated mechanism of action, and a safety profile that does not require ongoing MRI surveillance.
Beyond Alzheimer’s, Anavex is advancing other candidates targeting central nervous system disorders, including Parkinson’s disease, schizophrenia, and Rett syndrome.