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Biogen Inc.

Class Action
  • Active
Investigation
01/11/2022
Initial Lawsuit
02/07/2022
Lawsuit Progression
05/06/2022

Investigation

This investigation concerns Biogen’s statements made in connection with the approval of Aduhelm, its safety, efficiency, and subsequent marketability.

We have opened this page for investors to gather facts, and findings, and track related lawsuits. We invite investors and shareholders to read the events in the factual timeline below, add any and vote on their pertinence.

A lawsuit was subsequently filed. A judge might answer these questions in a court of justice. We will update this post as it unfolds.

  • Investigation Date
    01/11/2022
  • Hypothetical Affected Period
    June 7, 2021 to January 11, 2022
  • Hypothetical Transgression
    Securities Violation
Main Event

Medicare on Clinical Trials

01/11/2022

U.S. Agency

The Centers for Medicare & Medicaid Services (CMS) releases a proposed National Coverage Determination (NCD) decision memorandum covering the Food and Drug Administration (FDA) approved monoclonal antibodies that target amyloid for the treatment of Alzheimer’s disease through coverage with evidence development (CED). The NCD meant that FDA-approved drugs in this category “would be covered for people with Medicare only if they are enrolled in qualifying clinical trials.”

The stock impact compares the closing price immediately preceding the date of the event and the following closing price. The price difference also reflects the overall mix of information.

Stock Impact

Close Previous close Price variation Percentage variation
$225.34 $241.52 $-16.18 -6.7%
See more on Factual Timeline

Initial Lawsuit

First Complaint - 02/07/2022

A shareholder brought this securities class action on behalf of all investors who purchased or otherwise acquired defendant Biogen, Inc, common stock between June 7, 2021, and January 11, 2022, inclusive.

  • Filing Date
    02/07/2022
  • Class Period
    06/07/2021 to 01/11/2022
  • Transgression
    Securities Violation
  • Filing Firms
    Block & Leviton, LLP
  • Case Title
    Oklahoma Firefighters Pension and Retirement System v. Biogen Inc. et al
  • Docket Number
    1:22-cv-10200
  • Court
    Massachusetts District Court
  • Free File
    Complaint

Allegations

According to the complaint, 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 allegedly failed to disclose to investors that:

(i) in discussing the two Phase III studies, Biogen omitted to disclose that one of the studies was deemed a failure, and that the justification for approval came by disregarding that study;

(ii) the danger to patients was a key factor in both the Advisory Panel recommending against and later international regulators outright denying approval of Aduhelm;

(iii) entities had not committed to paying for Aduhelm treatment at any price given its questionable efficacy and safety issues, let alone at $56,000 per year;

(iv) Medicare coverage was a certainty when, in fact, it was not;

(v) the clinical data did not support a clinical benefit by taking Aduhelm and that side-effects were dangerous and serious . . . (see complaint for detailed allegations).

Defendants

  • Company
    Biogen Inc.
  • Chief Executive Officer
    Michael Vounatsos
  • Chief Financial Officer
    Michael McDonnell
  • Chief Financial Officer
    Jeffrey Capello
  • Chief Medical Officer
    Alfred Sandrock

Lawsuit progression

  • Docket Number
    1:22-cv-10200
  • Court
    Massachusetts District Court

Lead Counsel

05/06/2022

The court issued an order appointing the lead plaintiff and lead counsel.

Amended Complaint

06/27/2022

    Operative complaint

Factual Timeline

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