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Biotech stocks Facing FDA Decision in January 2023

Eisai
Eisai

Eisai Co. Ltd.’s (ESALY.OB) Lecanemab, proposed for the treatment of mild cognitive impairment due to Alzheimer’s disease and mild Alzheimer’s with confirmed presence of amyloid pathology in the brain, awaits the FDA decision on January 6, 2023.

Lecanemab is an investigational humanized monoclonal antibody, borne out of a strategic research alliance between BioArctic and Eisai.

This compound selectively binds to neutralize and eliminate soluble toxic amyloid beta aggregates (protofibrils) that are thought to contribute to the neurodegenerative process in Alzheimer’s disease.

Eisai and Biogen have a development and commercialization agreement for Lecanemab that was signed in March 2014.

Lecanemab is being reviewed under Priority Review.

If all goes well, Lecanemab will be the third Alzheimer’s drug of Eisai to be greenlighted.
Eisai's first Alzheimer's treatment, Aricept, received FDA approval in 1997. It was followed by Aduhelm, which received FDA approval in 2021.

ESALY.OB closed Friday’s trading at $65.06, down 2.58%.