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.
Submit Your Information
If you suffered a loss on your Biogen, Inc. investments or would like to inquire about joining an action to recover your loss under the federal securities laws, please complete the form below. Please note that submission of this form does not by itself form an attorney-client relationship nor does filing out this form mean you have joined any lawsuit.