Shares of Anavex Life Sciences Corp. (AVXL) surged 15.87% in pre-market trading on Monday, following the company's announcement that the European Medicines Agency (EMA) has accepted for review the Marketing Authorization Application (MAA) for its investigational drug, blarcamesine, as a potential treatment for Alzheimer's disease.

Blarcamesine is an orally administered small molecule designed to target the underlying pathology of Alzheimer's disease through autophagy enhancement. In clinical trials, the drug demonstrated clinically meaningful improvement in slowing cognitive decline in early Alzheimer's disease patients over 48 weeks, suggesting superior numerical clinical efficacy compared to approved therapies.

Importantly, blarcamesine exhibited a favorable safety profile, indicating no need for routine MRI monitoring. With its differentiated mechanism of action, the once-daily oral treatment could represent a novel and convenient treatment option, potentially complementary or an alternative to injectable anti-beta amyloid monoclonal antibody drugs.

The acceptance of the MAA by the EMA marks a significant milestone for Anavex, bringing the company a step closer to offering a broader patient access to a new treatment option in Europe. With an estimated 7 million people in Europe living with Alzheimer's disease, and the number expected to double by 2030, the potential market opportunity for an effective and accessible treatment is substantial.