Sesen Bio (NASDAQ:SESN) stock is rising higher on Wednesday after revealing plans to meet with the U.S. Food and Drug Administration (FDA).
According to an 8-K filing with the U.S. Securities and Exchange Commission (SEC), Sesen Bio is taking part in a CMC Type A Meeting with the FDA on Oct. 29. This will have it going over what needs to happen for Vicineum to get approval in the U.S.
To go along with this, Sesen Bio notes it has also pulled its marketing authorization application (MAA) to the European Medicines Agency (EMA) for Vysyneum. It did this so that it can have FDA approval first before attempting to enter the European market.
Sesen Bio notes that approval in Europe is more likely to happen if its treatment is already approved in the U.S. Vicineum is its treatment for BCG-unresponsive non-muscle invasive bladder cancer.
Sesen Bio stated the following in the SEC filing.
‘As previously disclosed, Sesen Bio intends to use information from its CMC Type A Meeting, which has been scheduled for October 29, 2021, and the Clinical Type A Meeting anticipated to occur later in the fourth quarter to determine the appropriate path forward with regulators.”
SESN stock is seeing heavy trading following the FDA news today. As of this writing, more than 153 million shares of the stock have been traded. That’s a massive surge compared to its daily average trading volume of 21 million shares.
SESN stock was up 32.6% as of Wednesday afternoon.
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On the date of publication, William White did not have (either directly or indirectly) any positions in the securities mentioned in this article. The opinions expressed in this article are those of the writer, subject to the InvestorPlace.com Publishing Guidelines.
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