: Biogen Alzheimer’s drug appears to have setback as FDA advisers recommend not to approve

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Biogen Inc. BIIB appears to have suffered a setback on Friday at the hands of a Food and Drug Administration advisory panel over recommendation to approve its experimental Alzheimer’s disease treatment. On Friday, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee voted 8 to 1 against recommending approval of Biogen’s treatment aducanumab, while two members cast “undecided” votes, according to reports and multiple tweets Friday. Before markets opened, shares of Biogen were halted ahead of the panel meeting. While the FDA usually follows the recommendations of its advisory panels, the agency is not obliged to follow them. That’s important to note because FDA officials have already said clinical studies on the drug support approval. Shares of Biogen, which stood at $328.90 during the Friday halt, are up nearly 11% on the year, with a more than 30% gain over the past week alone. In comparison, the S&P 500 index SPX is up 8.6% for the year and 7.3% for the week.
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