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Sesen Bio, Inc.


Scott+Scott Attorneys at Law LLP (“Scott+Scott”), an international shareholder and consumer rights litigation firm, announces the filing of class action lawsuits against Sesen Bio, Inc. (“Sesen Bio” or the “Company”) (NASDAQ: SESN) and certain of its officers and directors alleging violations of federal securities laws.  If you purchased Sesen Bio securities between December 21, 2020 and August 17, 2021, inclusive (the “Class Period”) you are encouraged to contact Scott+Scott attorney Rhiana Swartz at rswartz@scott-scott.com or 844-818-6980 for more information. 

Sesen Bio is a late-stage clinical company that purports to advance targeted fusion protein (“TFP”) therapeutics for cancer treatments. Its most advanced product candidate is Vicineum.  Sensen Bio reported preliminary efficacy data from its ongoing Phase 3 clinical trial for Vicineum, the VISTA trial, in August 2019. 

On December 21, 2020, the Company announced that it had submitted its Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for Vicineum. 

The lawsuit alleges that Sesen Bio and the other defendants made materially false and/or misleading statements about the Vicineum and the BLA, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects.  Specifically, defendants failed to disclose that: (1) Sesen Bio’s clinical trial for Vicineum had more than 2,000 violations of trial protocol, including 215 classified as “major”; (2) three of Sesen Bio’s clinical investigators were found guilty of “serious noncompliance,” including “back-dating data”; (3) Sesen Bio had submitted the tainted data in connection with the BLA for Vicineum; (4) 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) as a result of the foregoing, the Company’s BLA for Vicineum was not likely to be approved; (6) 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) 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. 

On August 13, 2021, Sesen Bio announced that the FDA declined to approve its BLA for Vicineum in its current form. The FDA provided certain “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.” 

On this news, Sesen Bio’s share price fell $2.80, or 57%, to close at $2.11 per share on August 13, 2021. 

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 necessary for the FDA to assess the benefit-risk profile, which is the basis for approval.” As a result, the Company expected that it could not resubmit its BLA until 2023. 

On this news, Sesen Bio’s share price fell $0.89, or 42%, to close at $1.22 per share on August 16, 2021. 

Then, on August 18, 2021, before the market opened, the health and medicine news site STAT published an article entitled “Sesen Bio trial of cancer drug marked by misconduct and worrisome 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 “marked by thousands of violations of study rules, damning investigator conduct, and worrying signs of toxicity the company did not publicly disclose.” 

On this news, Sesen Bio’s share price fell $0.20, or 13%, to close at $1.31 per share on August 18, 2021, on unusually heavy trading volume. 

What You Can Do 

If you purchased Sesen Bio securities between December 21, 2020 and August 17, 2021, and you wish to discuss this lawsuit, please contact attorney Rhiana Swartz at (844) 818-6980, or at rswartz@scott-scott.comThe deadline to file for lead plaintiff is October 18, 2021. 

About Scott+Scott Attorneys at Law LLP 

Scott+Scott has significant experience in prosecuting major securities, antitrust, and employee retirement plan actions throughout the United States.  The firm represents pension funds, foundations, individuals, and other entities worldwide with offices in New York, London, Amsterdam, Connecticut, Virginia, California, and Ohio. 

Attorney Advertising 

CONTACT: 

Rhiana Swartz 

Scott+Scott Attorneys at Law LLP 

230 Park Ave, 17th Fl, NY, NY 10169 

(844) 818-6980 

rswartz@scott-scott.com 

On this news, the Company’s share price fell $0.89, or 42%, to close at $1.22 per share on August 16, 2021, thereby injuring investors further.

Then, on August 18, 2021, before the market opened, STAT published an article entitled “Sesen Bio trial of cancer drug marked by misconduct and worrisome 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 “marked by thousands of violations of study rules, damning investigator conduct, and worrying signs of toxicity the company did not publicly disclose.”

On this news, the Company’s share price fell $0.20, or 13%, to close at $1.31 per share on August 18, 2021, thereby injuring investors further.

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Securities