- The stock price of Sesen Bio Inc (NASDAQ: SESN) increased by over 7% pre-market today. This is why it happened.
The stock price of Sesen Bio Inc (NASDAQ: SESN) increased by over 7% pre-market today. This is a continuation of momentum as the company shares increased 25.74% yesterday.
Investors are responding positively to a recent filing from the company.
Sesen Bio reported that pn the morning of October 19, 2021, the US Food & Drug Administration (FDA) granted them a request for a Type A meeting to discuss the Chemistry, Manufacturing and Controls (CMC) issues raised in the FDA’s Complete Response Letter (CRL) regarding their Biologics License Application (BLA) for Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer. The CMC Type A Meeting has been scheduled for October 29, 2021.
During the CMC Type A Meeting, the company intends to align on a path forward with the FDA related to the CMC issues raised in the CRL. The company is also preparing for a separate Type A meeting to discuss the recommendations specific to additional clinical/statistical data and analyses that the FDA raised in the CRL. And the company expects the Clinical Type A Meeting to occur later in the fourth quarter of 2021.
As previously disclosed, Sesen Bio plans to use the information from the CMC Type A Meeting and the Clinical Type A Meeting to synchronize the regulatory reviews of Vicineum for the treatment of BCG-unresponsive NMIBC in the US and the European Union. And Sesen Bio looks forward to continuing to work collaboratively with regulators to determine the appropriate path forward.
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