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sesen bio Sesen Bio Reports First Quarter 2021 Financial Results and Commercial Launch Readiness Update in the US for Vicineum ™ May 10 , 2021 Strengthened balance sheet with $ 110M in cash and cash equivalents as of March 31 , 2021 Company remains on track for potential approval in the US in August 2021 and in Europe in early 2022 Company to host conference call at 8am ET CAMBRIDGE , Mass .-- ( BUSINESS WIRE ) -- May 10 , 2021-- Sesen Bio ( Nasdaq : SESN ) , a late - stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer , today reported operating results for the first quarter ended March 31 , 2021. The Company's Biologics License Application ( BLA ) for the Company's lead program , Vicineum , is currently under Priority Review with the Food and Drug Administration ( FDA ) for the treatment of BCG - unresponsive non - muscle invasive bladder cer ( NMIBC ) with a target Prescription Drug User Fee Act date of August 18 , 2021 . " We are very pleased with the tremendous progress we continue to make in our four biggest global markets : the US , Europe , the Middle East and North Africa region and China , ” said Dr. Thomas Cannell , president and chief executive officer of Sesen Bio . " In the US , we continue to work with the FDA as we approach our target PDUFA date , and we are making substantial progress toward launch readiness . We are laser focused on bringing a product to market that we believe will improve patient outcomes while reducing overall healthcare costs to patients globally , and we expect to continue to make progress around the world in the coming months . ” US and OUS Regulatory Update US : • In February 2021 , Sesen Bio received notice from the FDA that the BLA for Vicineum was accepted for filing . Along with the acceptance , the Company was granted Priority Review with a target PDUFA date of August 18 , 2021 for a decision on the BLA . The FDA also stated that an advisory committee meeting was not currently planned to discuss the BLA . Europe : • On March 25 , 2021 , the Company was notified by the European Medicines Agency ( EMA ) that the Company's Marketing Authorization Application ( MAA ) for Vysyneum ™ was found to be valid and that the review procedure had officially started . Sesen Bio submitted the MAA on March 5 , 2021 , and the Company remains on - track for potential approval of Vysyneum in the EU in early 2022 . • On March 31 , 2021 , the Company received notice from the Committee for Medicinal Products for Human Use ( CHMP ) of the EMA that the CHMP has conditionally accepted the proprietary brand name Vysyneum for the Company's product candidate , oportuzumab monatox , in the EU . The Company believes Vysyneum is a brand name with strong marketing potential given its identical pronunciation to the US proprietary brand name Vicineum . Final approval of the Vysyneum brand name is conditional on EMA product approval . China : • The Investigational New Drug ( IND ) application for Vicineum for the treatment of BCG - unresponsive NMIBC submitted to the Center for Drug Evaluation ( CDE ) of the China National Medical Products Administration ( NMPA ) was approved on March 19 , 2021 ahead of the original timeline of April 2021. This approval triggers a $ 3M milestone payment to the Company , and authorizes Qilu Pharmaceutical , the Company's partner in China , to conduct the proposed clinical trial to assess the efficacy and safety of Vicineum in China , at the sole cost of Qilu Pharmaceutical . Assuming a successful trial , Qilu Pharmaceutical anticipates submission of the product market application for Vicineum in 2022 , with potential approval in China expected in 2023 .