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Anavex (AVXL) Rises as CHMP Deems Blarcamesine Eligible for MAA
Zacks Equity Research
Wed, December 20, 2023 at 11:09 AM EST
Anavex Life Sciences Corp. AVXL announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) considers its pipeline candidate, oral blarcamesine, eligible for a centralized regulatory review in the EU.
This indicates that Anavex may file a single marketing application to the European Medicines Agency. The company initiated the regulatory submission of blarcamesine for the treatment of Alzheimer’s disease to the EMA in November 2023.
The marketing authorization application, upon potential approval, will grant the company direct access to the European Union market. Anavex is planning to submit a marketing authorization application for blarcamesine at the earliest possible date in 2024.
Shares of the Anavex were up 13.2% on Dec 19 following the announcement of the news. The stock has rallied 15.6% in the past year against the industry’s decline of 19.6%.
Per the company, blarcamesine is being evaluated in a IIb/III clinical study for Alzheimer's disease. Besides showing significant improvement in dementia symptoms in the study, treatment with blarcamesine also led to a reduction in pathological aggregation of amyloid in early Alzheimer’s disease and reduced brain volume loss, a renowned marker of neurodegeneration.
Anavex’s orally administered blarcamesine is an easier-to-use formulation. The oral treatment does not require complex logistics resources and added personnel for drug administration and monitoring for brain edema and brain bleeds.
Anavex is also evaluating blarcamesine in several other central nervous system indications. The candidate is being developed in mid-to-late-stage studies for treating Rett syndrome, Parkinson's disease, schizophrenia, Fragile X and other rare diseases.
Zacks Rank & Other Stocks to Consider
Anavex currently carries a Zacks Rank #2 (Buy).
