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

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  • 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.
 

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Posted-In: bladder cancerBiotech News Penny Stocks Small Cap FDA General

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