Biogen soars 20% on plans to pursue Alzheimer's approval after FDA talks
Shares of Biogen are soaring after the company announced that, after consulting with the FDA, it plans to pursue regulatory approval for aducanumab, an investigational treatment for early Alzheimer's disease. "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. This new analysis of a larger dataset that includes additional data that became available after the pre-specified futility analysis shows that aducanumab is pharmacologically and clinically active as determined by dose-dependent effects in reducing brain amyloid and in reducing clinical decline as assessed by the pre-specified primary endpoint Clinical Dementia Rating-Sum of Boxes (CDR-SB). In both studies, the safety and tolerability profile of aducanumab was consistent with prior studies of aducanumab," The company plans to file a Biologics License Application in early 2020 and will continue dialogue with regulatory authorities in international markets including Europe and Japan. Shares of Biogen are up 21% in premarket trading, or $46.49, to $270.00.