
Amicus Therapeutics, Inc. (FOLD)
Whether directors and officers of Amicus Therapeutics, Inc. (FOLD) breached their fiduciary duties to the company and its shareholders.
Investigation
01/11/2022
Initial Lawsuit
02/07/2022
Lawsuit Progression
05/06/2022
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.
01/11/2022
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.”
Stock Impact
Close | Previous close | Price variation | Percentage variation |
---|---|---|---|
$225.34 | $241.52 | $-16.18 | -6.7% |
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.
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).
05/06/2022
The court issued an order appointing the lead plaintiff and lead counsel.
06/27/2022
Operative complaint
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