Sesen Bio Shares Gain On FDA Type A Meeting On Issues From Vicineum Response Letter

The FDA has granted Sesen Bio Inc's SESN request for a Type A meeting to discuss the Chemistry, Manufacturing, and Controls (CMC) issues raised in the Complete Response Letter for Vicineum for BCG-unresponsive non-muscle invasive bladder cancer.
Related: Sesen Bio Stock Crashes As FDA Shoots Down Its Bladder Cancer Pitch.
The CMC Type A Meeting has been scheduled for October 29.
The Company is also preparing for a separate Type A meeting to discuss the recommendations specific to additional data and analyses raised in the CRL.
The Company expects the Clinical Type A Meeting to happen later in Q4 of 2021.
Also Read: Sesen Bio's Bladder Cancer Trial Wrecked By Misconduct: Stat News.
Related content: Benzinga's Full FDA Calendar.
Price Action: SESN shares are up 11.9% at $1.13 during the premarket session on the last check Wednesday.