Kirby McInerney LLP Reminds Investors That a Class Action Lawsuit Has Been Filed on Behalf of Sesen Bio, Inc. (SESN) Investors and Encourages Investors to Contact the Firm Before October 18, 2021
NEW YORK, Aug 25, 2021 (GLOBE NEWSWIRE) – Law firm Kirby McInerney LLP reminds investors that a class action lawsuit has been filed in the U.S. District Court for the southern borough of New York on behalf of the acquirers of Sesen Bio, Inc. (” Sesen Bio ”or the“ Company ”) (NASDAQ: SESN) securities from December 21, 2020 through August 17, 2021 (the“ Class Period ”) inclusive. Investors have until October 18, 2021 to apply to the court to be named as the main plaintiff in the legal dispute.
Sesen Bio, a late-stage clinical company, is focused on the design, construction, development and commercialization of Targeted Fusion Protein Therapeutics (“TFPTs”) for the treatment of cancer patients. The company’s most advanced product candidate is Vicinieum, a locally administered, targeted fusion protein developed for the treatment of BCG-nonresponsive non-muscle invasive bladder cancer (“NMIBC”).
On August 13, 2021, Sesen Bio announced that the U.S. Food and Drug Administration (FDA) had declined to approve its biologics filing for its bladder cancer treatment Vicineum in its current form. The FDA issued certain “Recommendations specifically for additional clinical / statistical data and analysis in addition to Chemistry, Manufacturing and Control (” CMC “) related to a recent pre-screening and product quality.” , $ 80 per share, or about 57%, and closed 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 conduct a clinical trial to provide the additional efficacy and safety data the FDA needs to assess the benefit-risk profile on which the approval is based. ”On the basis of this news, the company’s share price fell $ 0.89 per share, or about 42%, and closed at $ 1.22 per share on August 16, 2021.
Then, on August 18, 2021, before the market opened, the health and medical news site STAT published an article entitled “Sesen Bio-Study with a cancer drug characterized by malpractice and worrying side effects, as 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 violations of study rules, devastating test behavior and worrying signs of toxicity” so the company did not publicly disclose it. “
The story goes on
The lawsuit alleges that defendants made materially false and / or misleading information and failed to disclose material adverse facts about the business, operations and prospects of the company during the class action period. Specifically, Defendants failed to disclose to investors: (1) that Sesen Bio’s clinical study for Vicineum revealed more than 2,000 study protocol violations, including 215 classified as 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 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.
If you have purchased or otherwise acquired securities from Sesen Bio, have information or would like to learn more about these claims, please contact Thomas W. Elrod of Kirby McInerney LLP at 212-371-6600, by email at research @ kmllp .com or by filling out this contact form to discuss your rights or interests in relation to these matters at no cost to you.
Kirby McInerney LLP is a New York based law firm focused on securities, antitrust, whistleblower and consumer disputes. The company’s efforts on behalf of shareholders in securities disputes have resulted in total returns of billions of dollars. For more information about the company, please visit the Kirby McInerney LLP website: http://www.kmllp.com.
This press release may be viewed as a solicitation in some jurisdictions subject to applicable laws and ethical rules.
Kirby McInerney LLP
Thomas W. Elrod, Esq.