Sesen Bio decimated as it gets CRL for Vicineum

16 August 2021

Shares of USA-based oncology specialist Sesen Bio (Nasdaq: SESN) were all but annihilated on Friday, after the company revealed a major setback for its lead drug candidate, with the stock falling 57% by close of trading and a further 17.5% to $1.74 in after-hours trading.

Sesen, previously known as Eleven Biotherapeutics, announced that it received a Complete Response Letter (CRL) from the US Food and Drug Administration its Biologics License Application (BLA) for Vicineum (oportuzumab monatox-qqrs) for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).

The FDA has determined that it cannot approve the BLA for Vicineum in its present form and has provided recommendations specific to additional clinical/statistical data and analyses in addition to Chemistry, Manufacturing and Controls (CMC) issues pertaining to a recent pre-approval inspection and product quality.

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