Sesen Bio 'Pleased' by Oct. 29 FDA Meeting on Lead Product Candidate Rejected in August
November 01 2021 - 3:05PM
Dow Jones News
By Josh Beckerman
Sesen Bio Inc. said it is "pleased" by the meeting it had with
the U.S. Food and Drug Administration on Oct. 29 related to an
August rejection letter for its lead product candidate
Vicineum.
The Type A meeting focused on questions related to Chemistry,
Manufacturing and Controls raised in the FDA's Complete Response
Letter for the company's Vicineum application for the treatment of
BCG-unresponsive non-muscle invasive bladder cancer. There will
also be a Clinical Type A meeting.
Sesen "believes it has a clear understanding" of what additional
information is required for resubmission.
The FDA also confirmed that Vicineum manufactured using the
proposed commercial process is comparable to Vicineum used in prior
clinical trials, Sesen said.
In August, Sesen said it was expanding its leadership team in
support of its "continued transformation into a commercial-stage
company." Shares fell sharply on Aug. 13 following the Complete
Response Letter. The stock was recently down 4%, to $1.16.
Write to Josh Beckerman at josh.beckerman@wsj.com
(END) Dow Jones Newswires
November 01, 2021 14:50 ET (18:50 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
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