Sesen Bio, Inc.
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It is alleged in this complaint that Sesen failed to disclose to investors: (1) that Sesen Bio’s clinical trial in relation to Vicineum had more than 2,000 violations of trial protocol, which included 215 classified as “major”; (2) that three of Sesen Bio’s clinical investigators were convicted of “serious noncompliance,” which included “back-dating data”; (3) that Sesen Bio had submitted the tainted data in relation to the BLA for Vicineum; (4) that Sesen Bio’s clinical trials found that Vicineum leaked out into the body, which led to side effects including liver failure and liver toxicity, and increasing the risks for fatal, drug-induced liver injury; (5) that, as a result of the foregoing, t was not likely Sesen’s BLA for Vicineum would be approved; (6) that, as a result of the foregoing, there was a reasonable likelihood that additional trials would be required to be conducted to support the efficacy and safety of Vicineum; and (7) that, as a result of the foregoing, Sesen’s positive statements in regard to Sesen’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis.