Sesen Bio Up 33% After Regulatory Updates
October 20 2021 - 4:12PM
Dow Jones News
By Josh Beckerman
Sesen Bio Inc. shares were recently up 33% to $1.34 after it
provided updates on U.S. and Europe drug approval steps in
securities filings.
Sesen said Tuesday that the Food & Drug Administration
granted its request for a Type A meeting to discuss the chemistry,
manufacturing and controls issues raised in the FDA's complete
response letter for Vicineum.
On Wednesday, Sesen said the European Medicines Agency issued a
withdrawal assessment report for the company's Vysyneum
application.
"Due to the high concordance between FDA and European Commission
approvals, the company believes that the probability of success of
future approval in the European Union for Vysyneum increases if FDA
approval for Vicineum has already been obtained," the company
said.
Sesen shares fell sharply in August when the FDA issued a CRL on
its application for Vicineum for treatment of BCG-unresponsive
non-muscle invasive bladder cancer.
Write to Josh Beckerman at josh.beckerman@wsj.com
(END) Dow Jones Newswires
October 20, 2021 15:57 ET (19:57 GMT)
Copyright (c) 2021 Dow Jones & Company, Inc.
Sesen Bio (NASDAQ:SESN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Sesen Bio (NASDAQ:SESN)
Historical Stock Chart
From Apr 2023 to Apr 2024
