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Biogen Plans To Submit BLA For Aducanumab In Alzheimer's Disease; Shares Jump

Biogen Inc. (BIIB) and Eisai, Co. Ltd. said, after consulting with the U.S. FDA, Biogen plans to pursue regulatory approval for aducanumab, an investigational treatment for early Alzheimer's disease. The decision is based on a new analysis, conducted by Biogen in consultation with the FDA, of a larger dataset from the Phase 3 clinical studies that were discontinued in March 2019.

Biogen plans to file a Biologics License Application in early 2020. The company said it will continue dialogue with regulatory authorities including those in Europe and Japan.

Biogen licensed aducanumab from Neurimmune under a collaborative development and license agreement. Since 2017, Biogen and Eisai have collaborated on the development and commercialization of aducanumab globally. Eisai Co., Ltd. is a global research and development-based pharmaceutical company headquartered in Japan.

Shares of Biogen Inc. were up more than 25% in pre-market trade on Tuesday.

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