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

by Vandana Singh, Benzinga Editor

February 16, 2021 9:13 AM | 1 min read |

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.