Benzinga | Jul 14, 2021 08:59AM EDT

Sesen Bio Announces Positive Outcome From Late-Cycle FDA Meeting For Vicineum Application

* Sesen Bio Inc (NASDAQ:SESN) participated in a Late-Cycle Meeting with the FDA regarding the marketing application seeking approval for Vicineum for BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

* The FDA confirmed that there is no Advisory Committee meeting planned at this time.

* No issues related to risk management have been identified to date.

* No post-marketing requirements, including a confirmatory trial, have been identified as necessary at this time.

* The Company believes the application remains on track for an anticipated regulatory decision by August 18, under the Priority Review status.

* Vicineum Sesen Bio's lead candidate is a locally administered fusion protein.

* Price Action: SESN shares are down 1.30% at $3.84 during the premarket session on the last check Wednesday.

* Related content: Benzinga's Full FDA Calendar.