Philadelphia, Pennsylvania--(Newsfile Corp. - September 17, 2021) - Berger Montague is investigating securities fraud allegations against Sesen Bio, Inc. ("Sesen" or the "Company"). The Firm is investigating these claims on behalf of investors who purchased Sesen securities (NASDAQ: SESN) between December 21, 2020 and August 17, 2021 (the "Class Period").
If you purchased Sesen securities during the Class Period, would like to discuss Berger Montague's investigation, or have questions concerning your rights or interests, please contact attorneys Andrew Abramowitz at firstname.lastname@example.org or (215) 875-3015, or Michael Dell'Angelo at email@example.com or (215) 875-3080.
Whistleblowers: Anyone with non-public information regarding Sesen is encouraged to confidentially assist Berger Montague's investigation or take advantage of the SEC Whistleblower program. Under this program, whistleblowers who provide original information may receive rewards totaling up to thirty percent (30%) of recoveries obtained by the SEC. For more information, contact us.
Sesen is a late-stage clinical company that purports to advance targeted fusion protein ("TFP") therapeutics for cancer treatments. Its most advanced product candidate is Vicineum (VB4-845), a locally administered TFP developed as a treatment of bacillus Calmette-Guérin ("BCG")-unresponsive non-muscle invasive bladder cancer ("NMIBC"). On December 21, 2020, the Company announced that it had submitted its Biologics License Application ("BLA") to the FDA for Vicineum for the treatment of BCG-unresponsive NMIBC.
On August 13, 2021, Sesen announced that the FDA declined to approve its BLA for Vicineum in its current form, and that 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.
On August 16, 2021, Sesen revealed that it 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. As a result, the Company expected that it could not resubmit the 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.
Then, on August 18, 2021, health news site STAT published an article entitled "Sesen Bio trial of cancer drug marked by misconduct and worrisome side effects, documents show." The article cited "hundreds of pages of internal documents" in reporting 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." On this news, Sesen's shares fell $0.20, or 13%, to close at $1.31 per share on August 18.
Berger Montague, with offices in Philadelphia, Minneapolis, Washington, D.C., and San Diego, has been a pioneer in securities class action litigation since its founding in 1970. Berger Montague has represented individual and institutional investors for over five decades and serves as lead counsel in courts throughout the United States.
Andrew Abramowitz, Senior Counsel
Michael Dell'Angelo, Managing Shareholder
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