- 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.
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Comments
Loading...
Benzinga simplifies the market for smarter investing
Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.
Join Now: Free!
Already a member?Sign in
