
Kewaunee Scientific Corporation (KEQU)
Whether directors and officers of Kewaunee Scientific Corporation (KEQU) breached their fiduciary duties to the company and its shareholders.
Investigation
08/13/2021
Initial Lawsuit
08/19/2021
Lawsuit Progression
10/29/2021
Did Sesen mislead investors about the trials for Vicineum, subsequent violations, noncompliance and the Biologics License Application (BLA)?
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A lawsuit was subsequently filed. We will update this post as it unfolds.
08/13/2021
Sesen discloses the receipt of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its Biologics License Application (BLA) for Vicineum (oportuzumab monatox-qqrs) for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
“The FDA has determined that it cannot approve the BLA for Vicineum in its present form and has provided recommendations specific to additional clinical/statistical data and analyses in addition to Chemistry, Manufacturing and Controls (CMC) issues pertaining to a recent pre-approval inspection and product quality.”
Stock Impact
Close | Previous close | Price variation | Percentage variation |
---|---|---|---|
$1.22 | $2.11 | $-0.89 | -42.18% |
A Sesen Bio, Inc. investor filed a securities class action lawsuit on behalf of persons and entities that purchased or otherwise acquired Sesen Bio securities between December 21, 2020, and August 17, 2021, 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:
(1) that Sesen Bio’s clinical trial for Vicineum had more than 2,000 violations of trial protocol, including 215 classified as “major”;
(2) that three of Sesen Bio’s clinical investigators were found guilty of “serious noncompliance,” including “back-dating data”;
(3) that Sesen Bio had submitted the tainted data in connection with the BLA for Vicineum;
(4) that Sesen Bio’s clinical trials showed that Vicineum leaked out into the body, leading to side effects including liver failure and liver toxicity, and increasing the risks for fatal, drug-induced liver injury;
(5) that, as a result of the foregoing, the Company’s BLA for Vicineum was not likely to be approved;
(6) that, as a result of the foregoing, there was a reasonable likelihood that Sesen Bio would be required to conduct additional trials to support the efficacy and safety of Vicineum; and
(7) that, as a result of the foregoing, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.
10/29/2021
The court issued an order appointing the lead plaintiff and lead counsel.
12/06/2021
Lead plaintiffs bring this securities class action lawsuit on behalf of persons and entities that purchased or otherwise acquired Sesen Bio securities between December 21, 2020 and August 17, 2021, inclusive.
Operative complaint
03/07/2022
A motion to dismiss was filed with the court.
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