Shares of Sesen Bio (SESN -6.47%) 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.
The biggest news for the biotech, though, was the FDA's decision to grant it Priority Review status. Normally, it takes 10 months from acceptance of a regulatory filing for the FDA to make an approval decision for a new drug. But Priority Review shortens the period to six months. Sesen expects the FDA will announce its approval decision for Vicineum by Aug. 18.
CEO Thomas Cannell said that the company has "reached an inflection point" with the FDA decisions announced today. The BLA acceptance, the decision to not require an advisory committee meeting, and the granting of Priority Review status appear to put Sesen on track to shift from being a clinical-stage biotech to a commercial-stage biotech.
FDA approval of Vicineum this summer could be a huge catalyst for the biotech stock. But it's also possible that Sesen's shares could receive a bump sooner than that. The company anticipates submission of its European regulatory filing for Vicineum within the next one to two months.