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Two weeks ago, Sesen Bio Inc (NASDAQ: 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).
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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