After FDA Rejection Troubled Biotech Pulls Europe Application For Bladder Cancer Drug

  • Two weeks ago, Sesen Bio Inc SESN was on the cusp of winning FDA approval for the cancer drug Vicineum.
  • It was working toward authorization in Europe. Now, with the FDA rejecting Vicineum for bladder cancer, Sesen has pulled its filing to the European Medicines Agency (EMA). 
  • Read: Sesen Bio's Bladder Cancer Trial Wrecked By Misconduct: Stat News.
  • Sesen said in an SEC filing that "certain components" of the EMA are "interrelated with elements" of the FDA's decision to reject Vicineum without providing further details. 
  • Sesen has halted plans to seek European approval until it has "more clarity" on the next steps in the U.S. Sesen expects to "better synchronize" the two reviews once it gets feedback from the FDA. 
  • Related content: Benzinga's Full FDA Calendar
  • Price Action: SESN shares are down 3.74% at $1.03 during the market session on the last check Thursday.
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