Sesen Bio (NASDAQ:SESN) stock is taking a beating on Monday following a letter from the U.S. Food and Drug Administration (FDA).
The letter from the FDA is in regards to the company’s Biologics License Application for Vicineum. It was seeking to use targeted fusion protein therapeutics for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC).
Unfortunately for SESN stock, the FDA said it’s unable to approve the company’s Biologics License Application. However, there is still hope. The FDA outlined some requirements it has for the company that might assist it with a future submission.
Sesen Bio intends to seek a Type A meeting with the FDA as soon as possible. This will allow it to discuss the letter as well as learn what needs to change before attempting another submission.
Dr. Thomas Cannell, president and CEO of Sesen Bio, said this about the news hammering SESN stock today.
“We are deeply disappointed by this unexpected result, and it is an unfortunate day for patients suffering from BCG-unresponsive NMIBC. We remain dedicated to our mission to save and improve the lives of patients by bringing new treatment options to patients, and we intend to work closely with the FDA to understand next steps.”
SESN stock is also seeing heavy trading today following the FDA news. That has more than 75 million shares of the stock changing hands as of this writing. This is a major jump compared to its daily average trading volume of about 9 million shares.
SESN stock was down 34.8% as of Monday morning but is still up 4.2% since the start of the year.
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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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