Benzinga | Feb 16, 2021 09:13AM EST

Sesen Bio's Vicineum US Application For Bladder Cancer Accepted For Review; Shares Spike

* Under priority review status, the FDA has accepted Sesen Bio Inc's (NASDAQ: SESN) marketing application for review seeking approval for Vicineum for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer.

* Additionally, the FDA stated that it is not currently planning to hold an advisory committee meeting to discuss the application.

* The agency's target action date is August 18.

* Vicineum is a locally administered fusion protein that targets epithelial cell adhesion molecule antigens on tumor cells' surface to deliver a potent protein payload, Pseudomonas Exotoxin A.

* Price Action: SESN gained 23.2% at $3.45 during premarket trading on the last check Tuesday.