Sesen Bio tanks as it pauses development of Vicineum in the USA

19 July 2022

Shares of US biotech firm Sesen Bio (Nasdaq: SESN) plunged nearly 32% to $0.62 yesterday, after it announced that it has made the strategic decision to voluntarily pause further development in the USA of its lead asset, Vicineum (oportuzumab monatox-qqrs).

The decision was based on a thorough reassessment of Vicineum, which included the incremental development timeline and associated costs for an additional Phase III clinical trial for the treatment of non-muscle invasive bladder cancer (NMIBC), following recent discussions with the US Food & Drug Administration (FDA).

Last year, Sesen, previously known as Eleven Biotherapeutics, announced that it received a Complete Response Letter (CRL) from the US FDA on its Biologics License Application (BLA) for Vicineum for the treatment of NMIBC.

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