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)

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