Investors in Sesen Bio (NASDAQ:SESN) are certainly disappointed today. The biotech company is sharing some bad news with investors today, as the Food and Drug Administration (FDA) shoots down the company’s newest cutting-edge therapeutic. SESN stock is seeing a significant downturn in the midst of this rejection.
Sesen Bio is a small cap biotech player based out of Massachusetts. The company develops fusion proteins medicines — medicines made from the combination of multiple genes. Specifically, Sensen combines tumor-combatting antibodies with a cytotoxic product in order to selectively kill cancer cells.
The company’s most recent cancer-treatment product is Vicineum, a medicine meant to treat bladder cancer. Earlier in the week, investors were getting excited about the treatment. The company has been looking to advance it to the market, and it believes the treatment is ready. Sensen has approached the FDA about approval for Vicineum, and investors have been expecting to hear back by early next week.
SESN Stock Plummets on Unanticipated Rejection
Well, things didn’t quite go as planned. The company is announcing today that it has heard back from the FDA, and Vicineum is not receiving approval. A complete response letter from the governing board to the company says it cannot approve the treatment in its present form. The letter also apparently comes with recommendations specific to clinical trial data the company is posting, as well as several chemical, manufacturing and control issues related to the treatment.
The company is obviously disappointed by the letter, which is a huge blow to the treatment. It is especially devastating given the medicine had received fast-track designation by the FDA as far back as 2018. The company remains steadfast in its goal to get the cancer treatment to the market as soon as possible. Speaking on the future of the drug, CEO Dr. Thomas Cannell says Sensen will collaborate closely with the FDA:
“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 having quite the rough day as investors deal with this disappointing revelation. The stock is plummeting over 57%, and it continues to lose after hours. Over 102 million shares of SESN are exchanging during today’s session, above the daily average volume of just 7 million.
On the date of publication, Brenden Rearick 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 biedexmarkets.com.com Publishing Guidelines.