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

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  • The FDA has granted Sesen Bio Inc's (NASDAQ: 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.

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