According to the lawsuit, defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that:
- Sesen Bio’s clinical trial for Vicineum (VB4-845), a locally administered targeted fusion protein (“TFP”) developed as a treatment of bacillus Calmette-Guérin (“BCG”)-unresponsive non-muscle invasive bladder cancer (“NMIBC”) had more than 2,000 violations of trial protocol, including 215 classified as “major”;
- three of Sesen Bio’s clinical investigators were found guilty of “serious noncompliance,” including “back-dating data”;
- Sesen Bio had submitted the tainted data in connection with the Biologics License Application (“BLA”) for Vicineum;
- 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;
- as a result of the foregoing, the Company’s BLA for Vicineum was not likely to be approved;
- 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
- 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.
No Class Has Been Certified. Until a class is certified, you are not represented by counsel unless you retain one. You may select counsel of your choice. You may also remain an absent class member and do nothing at this point. An investor’s ability to share in any potential future recovery is not dependent upon serving as lead plaintiff.
Attorney Advertising. Prior results do not guarantee a similar outcome.
