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Biogen, Inc.

Company NameBiogen, Inc.
Stock SymbolBIIB

On October 22, 2019, the Company announced that it would seek regulatory approval from the U.S. Food and Drug Administration (“FDA”) for aducanumab “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.” According to Biogen, the new analysis “show[ed] 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).”

 

On November 6, 2020, Reuters reported that an FDA panel found it “cannot ignore unsuccessful trial data on Biogen Alzheimer’s drug.” The panel had also “voted that an earlier-stage study does not offer supportive evidence of Biogen’s application for the drug, aducanumab.”

 

On this news, the Company’s stock price fell $92.64 per share, or 28%, to close at $236.26 per share on November 9, 2020, thereby injuring investors.

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