Biogen’s stock soars 42% in advance of FDA meeting on its Alzheimer’s disease therapy candidate

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Shares of Biogen soared 42.2% in trading on Wednesday after the Food and Drug Administration said there is “substantial evidence” that the company’s experimental Alzheimer’s disease drug is an effective treatment option. The agency’s review of the drug, aducanumab, was shared in a document released Wednesday in advance of a planned meeting of an FDA advisory committee on Friday. (As part of the FDA approval process for new drugs, a committee made up of independent experts convenes for a public meeting and makes a recommendation whether or not the FDA should approve a therapy. The regulator is not required to follow the advice of the committee but often does.) Biogen’s road to a FDA submission for aducanumab has been bumpy; in early 2019, the company said it would scrap development of the investigational drug after a futility analysis revealed the drug would not meet the primary endpoints in a Phase 3 trial. The decision sunk the company’s stock. A year ago, Biogen surprised investors when it announced plans to resurrect the drug based on a new analysis, a decision that has raised questions about the plausibility of an FDA approval by some analysts. Biogen’s stock so far this year has jumped 16.6%, while the S&P 500 is up 2.4%.
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