Sesen Bio Gets Unfavorable FDA Decision -- Update
August 13 2021 - 3:27PM
Dow Jones News
By Josh Beckerman
Sesen Bio Inc. said it is "deeply disappointed" after it
received a Complete Response Letter from the U.S. Food and Drug
Administration regarding its Biologics License Application for
Vicineum.
The company's shares were recently halted.
Sesen previously said it believed it was on track for an
decision by Aug. 18 for its Biologics License Application for
Vicineum for treatment of BCG-unresponsive non-muscle invasive
bladder cancer.
Shares have risen sharply in recent days. Prior to the halt
Friday, the stock was up 20% to $5.90.
Sesen said Wednesday that it was expanding its executive
leadership team in support of its "continued transformation into a
commercial-stage company."
The company said Friday that the FDA 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.
Sesen plans to request a Type A meeting with the FDA as soon as
possible.
Write to Josh Beckerman at josh.beckerman@wsj.com
(END) Dow Jones Newswires
August 13, 2021 15:21 ET (19:21 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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