Amicus Therapeutics, Inc. (FOLD)
Whether directors and officers of Amicus Therapeutics, Inc. (FOLD) breached their fiduciary duties to the company and its shareholders.
Investigation
04/26/2022
Initial Lawsuit
07/12/2022
Lawsuit Progression
09/12/2022
Did Molecular mislead investors regarding the effectiveness of ensovibep for the treatment of Covid-19 and the need for an additional Phase 3 study?
Were Covid-19 global rates impacting chances of receiving Emergency Use Authorization (EUA) for ensovibep from the U.S. Food and Drug Administration (FDA)?
Did the company mislead investors regarding the attractiveness of MP0310 to Amgen and the return of rights?
This post is open for investors to gather facts, and findings and track their exposure to related lawsuits. We invite investors and shareholders to contribute to this investigation for their own benefit, add events to the factual timeline below and vote on events’ pertinence.
A lawsuit was subsequently filed. We will update this post as it unfolds.
04/26/2022
Molecular’s partner Novartis’s CEO conducts their quarterly earnings call and provides an update on the EUA: “given the latest feedback . . . in our discussions with the [FDA], we would expect the agency to require a Phase 3 study before granting an EUA approval or a general approval” for ensovibep. Adding that they “need to make a kind of sober evaluation as to is it a doable study in light of the waning rates of COVID around the world.”
Molecular provides an update following comments provided by its partner Novartis:
“In the call, Novartis’ CEO, Vas Narasimhan stated that Emergency Use Application (EUA) for ensovibep, which is filed and in review with the U.S. Food and Drug Administration (FDA), may require additional clinical data to be authorized.“
Stock Impact
Close | Previous close | Price variation | Percentage variation |
---|---|---|---|
$13.89 | $16.57 | $-2.68 | -16.16% |
A Molecular Partners AG (MOLN) investor filed a federal securities class action lawsuit on behalf of a class consisting of all persons and entities (other than the defendants) that purchased or otherwise acquired:
(a) Molecular Partners American Depositary Shares (ADSs) pursuant and/or traceable to the offering documents issued in connection with the company’s initial public offering (IPO) conducted on or about June 16, 2021; and/or
(b) Molecular Partners securities between June 16, 2021, and April 26, 2022, both dates 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) ensovibep was less effective at treating COVID-19 than defendants had led investors to believe;
(ii) accordingly, the FDA was reasonably likely to require an additional Phase 3 study of ensovibep before granting the drug EUA;
(iii) waning global rates of COVID-19 significantly reduced the company’s chances of securing EUA for ensovibep;
(iv) as a product candidate, MP0310 was less attractive to Amgen than defendants had led investors to believe;
(v) accordingly, there was a significant likelihood that Amgen would return global rights of MP0310 to Molecular Partners;
(vi) as a result of all the foregoing, the clinical and commercial prospects of ensovibep and MP0310 were overstated; and
(vii) as a result, the offering document and defendants’ public statements throughout the class period were materially false and/or misleading and failed to state information required to be stated therein.
The lead plaintiff deadline has passed, we will update this page as the lawsuit progresses.
Last event retrieved on 09/26/2022.
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