Anavex Life Science Corp. (AVXL) announced that it has withdrawn its marketing authorization application for Blarcamesine in the European Union following feedback from regulators. The update reflects a change in the company's regulatory path for investigational Alzheimer's treatment.
Alzheimer's disease is the leading cause of dementia worldwide, accounting for 60-80% of cases. It is a progressive condition that worsens over time, affecting memory, thinking, and daily functioning. There remains a significant unmet need for treatments that can slow disease progression and reduce the burden on patients and caregivers.
Blarcamesine is Anavex's lead drug candidate, designed to target SIGMAR1 and muscarinic receptors with the goal of restoring cellular balance in neurodegenerative diseases. The therapy has completed multiple Phase 2 and Phase 3 studies across Alzheimer's disease, Parkinson's disease dementia, and Rett syndrome.
Regulators Said They Could Not Issue a Positive Opinion
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) informed Anavex that it would not be able to issue a positive opinion on the application at this time. In response, the company chose to withdraw the submission.Anavex originally filed the application after receiving encouragement from the EMA's SME Office in 2023, which advised the company to begin preparing for a marketing authorization filing. The company noted that the CHMP's current assessment differs from earlier guidance.
Company Plans to Gather Additional Data
Anavex said it will review the CHMP's feedback and focus on collecting additional data and conducting further analyses to address the issues raised. The company emphasized that it remains committed to advancing Blarcamesine and continues to receive strong support from Alzheimer's patients and advocacy groups, including Alzheimer Europe.
"We remain dedicated to advancing the development of innovative oral therapies for patients living with early Alzheimer's disease and to continuing our engagement with regulatory authorities," said Anavex President and CEO Christopher U. Missling, PhD.
AVXL has traded between $2.70 and $13.99 over the past year. The stock is currently trading at $2.87, down 31.56%. In today's session, shares touched a new 52-week low at $2.70.
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