Gibbs Law Group Investigates Potential Securities Law Violations
Sesen Bio, Inc. shares plummeted after a STAT News report claimed the FDA’s recent rejection of the company’s clinical trial for its drug Vicineum was due to “thousands of violations of study rules” and “damning investigator misconduct.” Previously, Sesen Bio dropped nearly 60% upon announcing this rejection from the FDA via a complete response letter (CRL) for its bladder cancer drug on Friday, August 13, 2021. Gibbs Law Group is investigating a potential Sesen Bio Securities Class Action Lawsuit on behalf of investors who lost money in Sesen Bio, Inc. (NASDAQ: SESN).
To speak with an attorney regarding this class action lawsuit investigation, click here or call (888) 410-2925.
On August 13, 2021, Sesen Bio reported its bladder cancer drug Vicineum failed to receive approval from the FDA. The company had received a complete response letter (CRL) that included recommendations addressing “additional clinical/statistical data and analyses” as well as “Chemistry, Manufacturing and Controls (CMC) issues.” Sesen Bio’s CEO claimed the result was “unexpected.”
Then on August 18, 2021, STAT News said it received internal documents allegedly revealing that the drug Vicineum had caused a patient death, and Sesen Bio had concealed this death in its reports on the drug. STAT further alleged that multiple doctors acting as investigators in the study had been found to be engaging in unethical behavior, including “back-dating data” and worse, “[placing] subjects at risk of harm.”
The patient death in Sesen Bio’s study allegedly occurred in 2016 and was “drug-related,” but STAT claims Sesen Bio failed to mention this death in subsequent reports, including a presentation at a major urology conference in 2018. Further, STAT reported in 2017 and 2018, an outside firm hired by Sesen Bio found three doctors in the Vicineum study were engaging in “serious noncompliance” that “placed subjects at risk of harm.” Another doctor in the study allegedly had his clinic closed in 2017 by his hospital’s disciplinary committee, and a separate doctor was found to be “back-dating data.” STAT further alleges Sesen Bio used data from these doctors in its application for FDA approval of Vicineum, despite being advised by an outside investigator that their data “cannot be used in any data analysis.”
Following STAT’s report, Sesen Bio’s stock price dropped 13% on August 18, 2021, causing significant harm to investors.
What Should Sesen Bio Investors Do?
If you invested in Sesen Bio, visit our website or contact our securities team directly at (888) 410-2925 to discuss how you may be able to recover your losses. Our investigation concerns whether Sesen Bio has violated federal securities laws by providing false or misleading statements to investors.
About Gibbs Law Group
Gibbs Law Group represents investors throughout the country in securities litigation to correct abusive corporate governance practices, breaches of fiduciary duty, and proxy violations. The firm has recovered over a billion dollars for its clients against some of the world’s largest corporations, and our attorneys have received numerous honors for their work, including “Best Lawyers in America,” “Top Plaintiff Lawyers in California,” “California Lawyer Attorney of the Year,” “Class Action Practice Group of the Year,” “Consumer Protection MVP,” and “Top Women Lawyers in California.”
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