SESN Sesen Bio Inc

By Josh Beckerman

Shares of Sesen Bio Inc. were down 75% to $1.21 as it received a Complete Response Letter from the U.S. Food and Drug Administration regarding its Biologics License Application for Vicineum.

The company said it is "deeply disappointed by this unexpected result."

The FDA provided recommendations specific to additional clinical/statistical data and analyses in addition to Chemistry, Manufacturing and Controls issues, the company said.

Sesen previously said it believed it was on track for an decision by Aug. 18 on the application for Vicineum for treatment of BCG-unresponsive non-muscle invasive bladder cancer. It said Wednesday that it was expanding its executive leadership team in support of its "continued transformation into a commercial-stage company."

Shares have risen sharply in recent days. Before the stock was halted for pending news, it was up 20% to $5.90.

Write to Josh Beckerman at josh.beckerman@wsj.com

(END) Dow Jones Newswires

August 13, 2021 15:42 ET (19:42 GMT)

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