Sesen Bio Shares Down 75% on Unfavorable FDA Decision
August 13 2021 - 2:43PM
Dow Jones News
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)
Copyright (c) 2021 Dow Jones & Company, Inc.
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