Anavex Life Sciences Corp. (AVXL) shares went up by 11% on Tuesday following the announcement that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has approved their oral blarcamesine for Alzheimer's disease, making it eligible for submission of a Union Marketing Authorisation application in the EU.
AVXL is trading on the Nasdaq at $9.77, up 11.18% or $0.98 per share. It has traded between $4.90 and $11.93 in the past 52-week period.
The ANAVEX 2-73-AD-004 Alzheimer's disease placebo-controlled Phase 2b/3 trial showed that blarcamesine not only significantly improved dementia symptoms but also reduced pathological aggregation of amyloid in early Alzheimer's disease and brain volume loss, a well-known marker of neurodegeneration.
Blarcamesine has a broader potential market compared to monoclonal antibodies, as it only requires a physician-assessed diagnosis of Alzheimer's disease and not any invasive amyloid positron emission tomography (PET) scans or lumbar punctures (spinal tap).
Once approved, blarcamesine will be marketed in all EU member states. Anavex is planning to submit the Marketing Authorisation Application in 2024.
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