Shares of Sesen Bio Inc. (NASDAQ: SESN) were trading sharply higher following a company announcement that the FDA granted its request for a Type A Meeting to discuss the issues brought up within the complete response letter (CRL) response to Vicineum.
Sesen Bio received a CRL response to their bladder cancer candidate Vicineum back on August 16th due to a combination of manufacturing issues and requests for additional data and statistical analyses. Previously, the FDA gave Sesen Bio priority review regarding its Vicineum program, which attempts to target specific antigens on the surface of tumor cells to treat cancers.
During the meeting, the company intends to align on a path forward with the FDA regarding the issues brought up within the CRL. Additionally, Sesen Bio is also preparing for a separate Clinical Type A meeting with the FDA in order to discuss recommendations specific to the requests for additional data and statistical analyses.
Sesen Bio Inc. is a late-stage clinical company engaged in next-generation antibody-drug conjugate therapies for the treatment of cancer based on the company’s Targeted Protein Therapeutics platform.
At the time of publication, shares of Sesen Bio Inc. were trading 16.8% higher during after hours at $1.18, extending gains on the day following a 7.60% rally during market hours.
The stock has a 52-week low of $0.70 and a 52-week high of $6.04.
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