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

Sesen Bio Inc 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.