FDA Declines to Approve Sesen Bio’s Bladder Cancer Treatment, Shares Plunge

Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Md., on Aug. 29, 2020. Andrew Kelly/Reuters

The Food and Drug Administration (FDA) has declined to approve Sesen Bio Inc’s lead therapy candidate for a type of bladder cancer, the company said on Friday, sending its shares down more than 80 percent.

The FDA notified the drug developer that it cannot approve the marketing application for the drug, Vicineum, in its present form.