Biogen Alzheimer's Filing Begins Months-Long FDA Process -- Market Talk 10:54 am ET July 8, 2020 (Dow Jones) Print 10:54 ET - The FDA approval process isn't usually watched so closely, but in the case of Biogen's aducanumab--the company's potential blockbuster Alzheimer's drug--each incremental step is a milestone. Biogen gains 5% after submitting an approval application to FDA, and the regulator now has two months to declare whether it will accept the filing and kick off another months-long review process before an approval decision sometime next year. If FDA accepts the fling, shares could move even higher, says Leerink, which "still believe that the FDA wants to approve this drug in early Alzheimer's," despite controversial data backing its effectiveness. R.W. Baird sees "review acceptance as likely but believe the application falls woefully short of being approvable," and predicts the FDA will ultimately reject the drug. ([email protected]) (END) Dow Jones Newswires July 08, 2020 10:54 ET (14:54 GMT) Copyright (c) 2020 Dow Jones & Company, Inc.