Press release
Lawsuit filed for Investors in Sesen Bio, Inc. (NASDAQ: SESN) over alleged Violations of Securities Laws
An investor, who purchased shares of Sesen Bio, Inc. (NASDAQ: SESN), filed a lawsuit over alleged Securities Laws violations by Sesen Bio, Inc.
Investors who purchased shares of Sesen Bio, Inc. (NASDAQ: SESN) have certain options and for certain investors are short and strict deadlines running. Deadline: October 18, 2021. NASDAQ: SESN investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.
Cambridge, MA based Sesen Bio, Inc., a late-stage clinical company, focuses on designing, engineering, developing, and commercializing targeted fusion protein therapeutics (TFPTs) for the treatment patients with cancer.
On December 21, 2020, Sesen Bio, Inc. announced that it had submitted its Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for Vicineum for the treatment of BCG-unresponsive NMIBC.
On August 13, 2021, Sesen Bio, Inc. announced that FDA declined to approve its Biologics License Application for its bladder cancer treatment 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 August 16, 2021, Sesen Bio, Inc 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 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.”
Shares of Sesen Bio, Inc. (NASDAQ: SESN) declined from $6.04 per share on August 13, 2021, to as low as $0.922 per share on August 20, 2021.
The plaintiff claims that between December 21, 2020 and August 17, 2021, the Defendants failed to disclose to investors, that Sesen Bio’s clinical trial for Vicineum had more than 2,000 violations of trial protocol, including 215 classified as “major”, that three of Sesen Bio’s clinical investigators were found guilty of “serious noncompliance,” including “back-dating data”, that Sesen Bio had submitted the tainted data in connection with the BLA for Vicineum, 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, that, as a result of the foregoing, the Company’s BLA for Vicineum was not likely to be approved, 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 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.
Those who purchased shares of Sesen Bio, Inc. (NASDAQ: SESN) have certain options and should contact the Shareholders Foundation.
Contact:
Michael Daniels
Shareholders Foundation, Inc.
3111 Camino Del Rio North
Suite 423
San Diego, CA 92108
Tel: +1-(858)-779-1554
E-Mail: mail@shareholdersfoundation.com
About Shareholders Foundation, Inc.
The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, and an investor advocacy group, which does research related to shareholder issues and informs investors of securities lawsuits, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigations, and/or settlements are not filed/initiated/reached and/or are not related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.
Investors who purchased shares of Sesen Bio, Inc. (NASDAQ: SESN) have certain options and for certain investors are short and strict deadlines running. Deadline: October 18, 2021. NASDAQ: SESN investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.
Cambridge, MA based Sesen Bio, Inc., a late-stage clinical company, focuses on designing, engineering, developing, and commercializing targeted fusion protein therapeutics (TFPTs) for the treatment patients with cancer.
On December 21, 2020, Sesen Bio, Inc. announced that it had submitted its Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for Vicineum for the treatment of BCG-unresponsive NMIBC.
On August 13, 2021, Sesen Bio, Inc. announced that FDA declined to approve its Biologics License Application for its bladder cancer treatment 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 August 16, 2021, Sesen Bio, Inc 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 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.”
Shares of Sesen Bio, Inc. (NASDAQ: SESN) declined from $6.04 per share on August 13, 2021, to as low as $0.922 per share on August 20, 2021.
The plaintiff claims that between December 21, 2020 and August 17, 2021, the Defendants failed to disclose to investors, that Sesen Bio’s clinical trial for Vicineum had more than 2,000 violations of trial protocol, including 215 classified as “major”, that three of Sesen Bio’s clinical investigators were found guilty of “serious noncompliance,” including “back-dating data”, that Sesen Bio had submitted the tainted data in connection with the BLA for Vicineum, 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, that, as a result of the foregoing, the Company’s BLA for Vicineum was not likely to be approved, 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 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.
Those who purchased shares of Sesen Bio, Inc. (NASDAQ: SESN) have certain options and should contact the Shareholders Foundation.
Contact:
Michael Daniels
Shareholders Foundation, Inc.
3111 Camino Del Rio North
Suite 423
San Diego, CA 92108
Tel: +1-(858)-779-1554
E-Mail: mail@shareholdersfoundation.com
About Shareholders Foundation, Inc.
The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, and an investor advocacy group, which does research related to shareholder issues and informs investors of securities lawsuits, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigations, and/or settlements are not filed/initiated/reached and/or are not related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.
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