SESEN BIO INVESTORS 120 0 Kommentare October 18, 2021 Filing Deadline in Class Action – Contact Lieff Cabraser - Seite 2

On August 13, 2021, Sesen Bio revealed that the FDA declined to approve its BLA for Vicineum. In its complete response letter (“CRL”), the FDA outlined “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 stock price fell $2.80 per share, or 57%, from its closing price of $4.91 on August 12, 2021, to close at $2.11 per share on August 13, 2021, on unusually heavy trading volume.

Then, on August 16, 2021, Sesen Bio announced it needed “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 stock price fell $0.89 per share, or 42%, from its closing price of $2.11 on August 12, 2021, to close at $1.22 per share on August 16, 2021, on unusually heavy trading volume.

Finally, on August 18, 2021, before the market opened, the health and medicine news site STAT published an article revealing “thousands of violations of study rules, damning investigator conduct, and worrying signs of toxicity the company [Sesen] did not publicly disclose” regarding its clinical trial for Vicineum. The STAT article was reportedly based on cited “hundreds of pages of internal documents” and “three people familiar with the matter.” On this news, the Company’s stock price fell $0.20 per share, or 13%, from its closing price of $1.51 on August 17, 2021, to close at $1.31 per share on August 18, 2021, on unusually heavy trading volume.

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