Shares of Sesen Bio (NASDAQ: SESN) were 10.2% higher as of 11:48 a.m. EST on Tuesday. The big jump came after the company announced that the Food and Drug Administration accepted its Biologics License Application (BLA) filing for Vicineum in treating bladder cancer. The FDA also granted Priority Review status for the application.
Acceptance of the BLA for Vicineum clears one more hurdle toward Sesen’s lead candidate winning FDA approval. The agency also said that it doesn’t plan to convene an advisory committee to review the BLA for Vicineum. That removes yet another potential hurdle.