Biogen, Inc.
Company Name | Biogen, Inc. |
Stock Symbol | BIIB |
Class Period | October 22, 2019 to November 06, 2020 |
Lead Plaintiff Motion Deadline | January 12, 2021 |
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.
The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (1) the larger dataset did not provide necessary data regarding aducanumab’s effectiveness; (2) the EMERGE study did not and would not provide necessary data regarding aducanumab’s effectiveness; (3) the PRIME study did not and would not provide necessary data regarding aducanumab’s effectiveness; (4) the data provided by the Company to the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee did not support finding efficacy of aducanumab; and (5) as a result, Defendants’ statements about its business, operations, and prospects, were materially false and misleading and/or lacked a reasonable basis at all relevant times.
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