Sesen Down After Outlining Regulatory Path for Vicineum in Bladder Cancer
December 09 2021 - 9:48AM
Dow Jones News
By Michael Dabaie
Sesen Bio Inc. shares were down 20% to 87 cents in premarket
trading after the late-stage clinical company outlined its
anticipated regulatory path forward for Vicineum for the treatment
of bladder cancer.
Sesen said it plans to conduct an additional clinical trial for
potential resubmission of a biologics license application.
The company said this followed a meeting with the U.S. Food and
Drug Administration.
Sesen said the anticipated randomized trial design is aligned
with guidance it received from the European Medicines Agency, which
may help to coordinate the regulatory paths forward for Vicineum in
the U.S. and the European Union.
The company said it expects to hold a meeting with the FDA in
early 2022 to discuss the protocol for the additional clinical
trial.
Sesen in August said it received a rejection letter from the FDA
regarding its application for Vicineum in bladder cancer.
Write to Michael Dabaie at michael.dabaie@wsj.com
(END) Dow Jones Newswires
December 09, 2021 09:33 ET (14:33 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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