Published: Oct 22, 2019 6:39 a.m. ET

Biogen BIIB, +33.32% 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.