Sesen Bio (NASDAQ:SESN) is up 12% premarket on light volume in response to its announcement that the FDA has designated lead candidate Vicinium for Fast Track review for the treatment of BCG-unresponsive high-grade non-muscle invasive bladder cancer.
A Phase 3 clinical trial, VISTA, for the indication is in process.
Fast Track status provides for more frequent interaction with the FDA review team and a rolling review of the marketing application.
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