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)

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