Pomerantz Law Firm Announces Class Action Filing Against Sesen Bio, Inc. and Certain Executives
Sep 21, 2021 2:33 PM ET
Legal Newswire POWERED BY LAW.COM
Pomerantz LLP announces that a class action lawsuit has been filed against Sesen Bio, Inc. and certain of its officers. The class action, filed in United States District Court of the Southern District of new York, and listed under 21-cv-07309, is in the name of a class consisting of all persons and entities other than the Defendants who have purchased or otherwise acquired securities of Sesen Bio between December 21, 2020 and August 17, 2021, inclusive (the âRecourse Periodâ). The plaintiff is pursuing actions against the defendants under the Securities Exchange Act of 1934 (the “Exchange Act”).
If you are a shareholder who purchased or otherwise acquired the securities of Sesen Bio during the Class Period, you have up to October 18, 2021 ask the court to appoint you as the principal plaintiff for the class. A copy of the complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby To [emailÂ protected] or 888.476.6529 (or 888.4-POMLAW), toll free, Ext. 7980. Those inquiring by e-mail are encouraged to provide their mailing address, telephone number and the number of shares purchased.
Sesen Bio is an advanced stage clinical company claiming to advance targeted fusion protein (âTFPâ) therapies for cancer treatments. Its most advanced product candidate is Vicineum (VB4-845), a topically administered PTF developed for the treatment of unresponsive Calmette-GuÃ©rin bacillus (âBCGâ) -muscular non-invasive bladder cancer (âNMIBCâ). Sesen Bio has published preliminary data on the efficacy of its ongoing Phase 3 clinical trial for Vicineum, the VISTA trial, in August 2019.
At December 21, 2020, the Company announced that it has submitted its biologic license application (âBLAâ) to the United States Food and Drug Administration (âFDAâ) for Vicineum for the treatment of NMIBCs not responding to BCG.
The complaint alleges that, throughout the Class Period, the Defendants made materially false and / or misleading statements, and failed to disclose material adverse facts regarding the business, operations and prospects of the Company. Specifically, the Defendants failed to disclose to investors: (1) that the clinical trial of Sesen Bio for Vicineum contained more than 2,000 trial protocol violations, of which 215 were classified as âmajorâ; (2) that three of Sesen Bio’s clinical investigators were found guilty of “serious non-compliance”, including “backdated data”; (3) that Sesen Bio had submitted flawed data related to the BLA for Vicineum; (4) that clinical trials of Sesen Bio have shown that Vicineum has entered the body causing side effects, including liver failure and liver toxicity, and increasing the risk of fatal drug-induced liver damage; (5) that due to the above, the Company’s BLA for Vicineum was not likely to be approved; (6) that due to the foregoing, there was a reasonable likelihood that Sesen Bio would be required to conduct additional trials to substantiate the efficacy and safety of Vicineum; and (7) that as a result of the foregoing, the Defendants’ positive statements regarding the activities, operations and prospects of the Company were substantially misleading and / or lacked reasonable basis.
At August 13, 2021, Sesen Bio has announced that the FDA has refused to approve its BLA for Vicineum in its current form. The FDA has provided some “specific recommendations for additional clinical / statistical data and analysis in addition to chemistry, manufacturing and controls (CMC) issues regarding a recent pre-approval inspection and product quality.”
Following this news, the Company’s share price fell $ 2.80, or 57%, to close at $ 2.11 per share on August 13, 2021, on an unusually high volume of transactions.
Then on August 16, 2021, Sesen Bio further revealed that “it appears that [the Company] will need to do a clinical trial to provide the additional efficacy and safety data needed by the FDA to assess the benefit-risk profile, which is the basis for approval. 2023.
Following this news, the Company’s share price fell $ 0.89, or 42%, to close at $ 1.22 per share on August 16, 2021, on an unusually high volume of transactions.
Then on August 18, 2021, ahead of the market opening, health and medicine news site STAT published an article titled “Sesen Bio Trial of Cancer Drug Marked by Misconduct and Worrisome Side Effects, According to Documents.” Citing “hundreds of pages of internal documents” and “three people familiar with the matter”, the article states that the clinical trial for Vicineum was “marked by thousands of violations of study rules, damning conduct by investigators and the worrying signs of toxicity from the company have not been publicly disclosed. “
Following this news, the Company’s share price fell $ 0.20, or 13%, to close at $ 1.31 per share on August 18, 2021, on an unusually high volume of transactions.
Pomerantz LLP, with offices in new York, Chicago, Los Angeles, Paris, and Tel Aviv, is recognized as one of the leading firms in the areas of corporate, securities and antitrust litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class actions bar, Pomerantz was a pioneer in the field of securities class actions. Today, more than 85 years later, Pomerantz continues the tradition he established, fighting for the rights of victims of securities fraud, breach of fiduciary duty and professional misconduct. The firm has recovered numerous multi-million dollar damages on behalf of the members of the group. See www.pomlaw.com.
Robert S. Willoughby
888-476-6529 ext 7980
Robert S. Willoughby
888-476-6529 ext 7980
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