- The stock price of Sesen Bio Inc (NASDAQ: SESN) increased by over 15% pre-market. This is why it happened.
The stock price of Sesen Bio Inc (NASDAQ: SESN) increased by over 15% pre-market. The company had announced the FDA has granted its request for a Type A meeting in order to discuss issues in the complete response letter that was received for the marketing application for Vicineum, the company’s lead product candidate being developed for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
The Chemistry, Manufacturing and Controls (CMC) Type A Meeting is now scheduled for October 29. And the company is also planning to set up a separate Clinical Type A Meeting, which will likely happen in Q4 2021.
Back in August, Sesen Bio revealed that the FDA determined that it cannot approve the Biologics License Application (BLA) for Vicineum in its present form and has provided recommendations specific to additional clinical/statistical data and analyses in addition to Chemistry, Manufacturing and Controls (CMC) issues pertaining to a recent pre-approval inspection and product quality.
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