UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
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Item 8.01 - Other Events.
On August 13, 2021, Sesen Bio, Inc. (the “Company”) issued a press release announcing that it had received a complete response letter from the US Food and Drug Administration regarding its Biologics License Application (“BLA”) for Vicineum™ for the treatment of BCG-unresponsive non-muscle invasive bladder cancer. The letter indicates that the FDA has determined that it cannot approve the BLA for Vicineum in its present form, and has provided recommendations specific to additional clinical/statistical data and analyses in addition to Chemistry, Manufacturing and Controls issues pertaining to a recent pre-approval inspection and product quality.
A copy of the press release is attached as Exhibit 99.1 to this report and is incorporated herein by reference.
Item 9.01 - Financial Statements and Exhibits.
(d) Exhibits.
Exhibit No. | Description | |
99.1 | Press Release dated August 13, 2021 | |
104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: August 13, 2021
Sesen Bio, Inc. | ||
By: |
/s/ Thomas R. Cannell, D.V.M. | |
Thomas R. Cannell, D.V.M. | ||
President and Chief Executive Officer |