Pomerantz Law Firm Announces the Filing of a Class Action Against Sesen Bio, Inc. and Certain Officers

New York, New York – (Newsfile Corp. – September 2, 2021) – Pomerantz LLP announces that a class action lawsuit has been filed against Sesen Bio, Inc. (“Sesen Bio” or the “Company”) (NASDAQ: SESN) and some of his officers. The class action lawsuit filed in the United States District Court for the Southern District of New York and filed on 21-cv-07309 is on behalf of a group consisting of all persons and entities other than the defendants, Sesen Bio bought or otherwise acquired securities between December 21, 2020 and August 17, 2021, inclusive (the “Class Period”). Plaintiff is pursuing claims against defendants under the Securities Exchange Act of 1934 (the “Exchange Act”).

If you are a shareholder who purchased or otherwise acquired Sesen Bio’s securities during the class action period, you have until October 18, 2021 to request the court to appoint you as the lead plaintiff for the class action. A copy of the complaint is available at www.pomerantzlaw.com. To discuss this promotion, contact Robert S. Willoughby at [email protected] or 888.476.6529 (or 888.4-POMLAW) toll free ext. 7980. Inquiries by email are encouraged to include their postal address, telephone number, and the number of shares purchased.

[Click here for information about joining the class action]

Sesen Bio is a late-stage clinical company purporting to be the advancement of targeted fusion protein (TFP) therapeutics for cancer treatments. Its most advanced product candidate is Vicineum (VB4-845), a topically administered TFP developed to treat Bacillus Calmette-Guérin (“BCG”) – non-responsive non-muscle invasive bladder cancer (“NMIBC”). In August 2019, Sesen Bio published preliminary efficacy data from its ongoing Phase 3 clinical trial for Vicineum, the VISTA study.

On December 21, 2020, the company announced that it has filed its Biologics License Application (“BLA”) for Vicineum for the treatment of NMIBC non-responsive to BCG with the US Food and Drug Administration (“FDA”).

The story goes on

The lawsuit alleges that during the class action period the defendants made materially false and / or misleading statements and failed to disclose material adverse facts about the company’s business, operations and prospects. Specifically, Defendants failed to disclose to investors: (1) that Sesen Bio’s clinical trial for Vicineum revealed more than 2,000 study protocol violations, including 215 rated “serious”; (2) that three of Sesen Bio’s clinical investigators have been found guilty of “serious non-compliance” including “backdated data”; (3) that Sesen Bio submitted the falsified data related to the BLA for Vicineum; (4) Sesen Bio’s clinical studies have shown that Vicineum leaks into the body, causing side effects such as liver failure and liver toxicity, and increasing the risk of fatal drug-induced liver damage; (5) that due to the foregoing, the Company’s BLA for Vicineum is unlikely to be approved; (6) that based on the foregoing, there was a reasonable likelihood that Sesen Bio would need to conduct additional studies to substantiate the efficacy and safety of Vicineum; and (7) that, based on the foregoing, Defendants’ positive statements about the business, operations, and prospects of the Company were materially misleading and / or improperly based.

On August 13, 2021, Sesen Bio announced that the FDA had rejected approval of their BLA for Vicineum in its current form. The FDA made certain “recommendations specific to additional clinical / statistical data and analysis in addition to chemistry, manufacturing and control (CMC) related to a recent pre-screening and product quality”.

As a result of this news, the company’s share price fell $ 2.80, or 57%, to close at $ 2.11 per share on August 13, 2021 with unusually high trading volume.

Then on August 16, 2021, Sesen Bio further revealed that “it appears that [the Company] will need to conduct a clinical trial to provide the FDA with the additional efficacy and safety data needed to assess the benefit-risk profile on which the approval is based. “As a result, the company expected to deliver its BLA first after 2023.

Based on this news, the company’s share price fell $ 0.89, or 42%, on an unusually high trading volume, to close at $ 1.22 per share on August 16, 2021.

Then, on August 18, 2021, ahead of the market opening, the health and medical news site STAT published an article titled “Sesen Bio-Study of Cancer Drug Characterized by Malpractice and Worrying Side Effects, Documents Show”. Citing “hundreds of pages of internal documents” and “three people familiar with the matter”, the article detailed that the clinical trial for Vicineum “was characterized by thousands of study rule violations, devastating test behavior and worrying signs of toxicity” not announced publicly. “

As a result of this news, the company’s share price fell $ 0.20, or 13%, due to an unusually high trading volume, and closed at $ 1.31 per share on August 18, 2021.

Pomerantz LLP, with offices in New York, Chicago, Los Angeles, Paris and Tel Aviv, is one of the leading law firms in corporate, securities and antitrust litigation. Founded by the late Abraham L. Pomerantz, best known as the Dean of the Class Action Chamber, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues the tradition he founded and fights for the rights of victims of securities fraud, breaches of duty of loyalty and corporate misconduct. The company has collected numerous millions of dollars in damages on behalf of class members. See www.pomlaw.com.

Robert S. Willoughby
Pomerantz LLP
[email protected]
888-476-6529 ext. 7980

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/95485

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