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Oct. 22, 2019, 6:39 a.m. EDT

Biogen says it will pursue FDA approval of early Alzheimer's drug

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By Steve Goldstein

BIIB

Biogen /zigman2/quotes/201531540/composite BIIB -1.60% said it will pursue regulatory approval for aducanumab, an investigational treatment for early Alzheimer's disease after consulting with the U.S. Food and Drug Administration. A Phase 3 trial met its primary endpoint showing a significant reduction in clinical decline, and Biogen believes that results from a subset of patients in the study who received sufficient exposure to high dose aducanumab support the finding. The decision to file 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 following a futility analysis.

Read the full story:
Biogen’s stock blasts off after surprise reversal on Alzheimer’s drug, earnings beat

/zigman2/quotes/201531540/composite
US : U.S.: Nasdaq
$ 288.54
-4.68 -1.60%
Volume: 905,514
Aug. 13, 2020 4:00p
P/E Ratio
8.45
Dividend Yield
N/A
Market Cap
$46.42 billion
Rev. per Employee
$1.55M
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