SESN stock rose more than 9% in pre-market trading on February 16, 2021, after the company announced that it has received priority review from the FDA for its Vicineum.
Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, announced today that the U.S. Food and Drug Administration (FDA) accepted for filing the Company’s Biologics License Application (BLA) for Vicineum for the treatment of high-risk, BCG-unresponsive non-muscle invasive bladder cancer (NMIBC), and granted the application Priority Review. In addition, the FDA stated that it is not currently planning to hold an advisory committee meeting to discuss the BLA for Vicineum.
The FDA grants Priority Review for medicines that treat a serious condition and, if approved, would be a significant improvement in the safety or effectiveness of the treatment, diagnosis, or prevention of such serious condition. Priority Review designation shortens the review period goal from the standard ten months to six months from the filing acceptance of the BLA. With Priority Review, the anticipated target Prescription Drug User Fee Act (PDUFA) date for a decision on the BLA is August 18, 2021.
“We have been meeting with the FDA regularly for the past two years on the application for Vicineum,” said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. “We understand the FDA’s position and guidance very clearly and have found the review process to be collaborative and engaging. With these critical FDA decisions, we have reached an inflection point for the Company. In addition to a clear regulatory path forward, we have continued to strengthen our balance sheet in preparation for the potential launch of a product we believe represents a significant advancement over available therapies. We remain focused on the patient and our mission to save and improve lives and expect to continue to make progress around the world in the coming months.”
In the next one to two months, the Company expects to submit its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for Vicineum for the treatment of high-risk, BCG-unresponsive NMIBC and receive an update from the Company’s partner, Qilu Pharmaceutical, regarding the possible approval of the Investigational New Drug (IND) application for Vicineum in China by the Center for Drug Evaluation (CDE).