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SESEN BIO DEADLINE ALERT Bragar Eagel & Squire, P.C. Reminds Investors that a Class Action Lawsuit Has Been Filed Against Sesen Bio, Inc. and Encourages Investors to Contact the Firm

Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, reminds investors that a class action lawsuit has been filed against Sesen Bio, Inc. (“Sesen Bio” or the “Company”) (NASDAQ: SESN) in the United States District Court for the Southern District of New York on behalf of all persons and entities who purchased or otherwise acquired Sesen Bio securities between December 21, 2020, and August 17, 2021, both dates inclusive (the “Class Period”). Investors have until October 18, 2021, to apply to the Court to be appointed as lead plaintiff in the lawsuit.

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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 for the treatment of BCG-unresponsive NMIBC.

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, the Company’s share price fell $2.80, or 57%, to close at $2.11 per share on August 13, 2021, on unusually heavy trading volume.

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, the Company’s share price fell $0.89, or 42%, to close at $1.22 per share on August 16, 2021, on unusually heavy trading volume.

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.”

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Nachrichtenquelle: Business Wire (engl.)
16.10.2021, 03:00  |  112   |   |   

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SESEN BIO DEADLINE ALERT Bragar Eagel & Squire, P.C. Reminds Investors that a Class Action Lawsuit Has Been Filed Against Sesen Bio, Inc. and Encourages Investors to Contact the Firm Bragar Eagel & Squire, P.C., a nationally recognized stockholder rights law firm, reminds investors that a class action lawsuit has been filed against Sesen Bio, Inc. (“Sesen Bio” or the “Company”) (NASDAQ: SESN) in the United States District Court …

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