new-recommended-broker-banner new-recommended-broker-banner
Practice Stock Trading Your Capital Is At Risk

Sesen Bio (SESN) Continues Decline Following Complete Response Letter

Updated: 16 Aug 2021

Sesen Bio (NASDAQ: SESN) shares have continued to decline on Monday following Friday's announcement that it received a complete response letter from the FDA regarding its Biologics License Application (BLA) for Vicineum.

new-recommended-broker-banner

Sesen Bio shares plunged over 57% on Friday, closing at $2.11 per share, and they are down another 17% premarket on Monday at $1.75.

Vicineum was being used as a potential treatment of BCG-unresponsive non-muscle invasive bladder cancer.

The FDA determined that it cannot approve the BLA for Vicineum and provided recommendations specific to additional clinical/statistical data and analyses and chemistry, manufacturing and controls issues about a recent pre-approval inspection and product quality.

“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,” stated Thomas Cannell on Friday, the President and CEO of Sesen Bio.

H.C. Wainwright analyst Swayampakula Ramakanth downgraded Sesen Bio to Neutral from Buy without a price target on Monday following the complete response letter. However, the analyst believes approval could be granted within the next 12 months.

Should You Invest in Sesen Bio Shares?

One of the most frequently asked questions we receive is, “what stocks are best to buy right now?” It's a wide-ranging question, but one that we have answered… Our AskTraders stock analysts regularly review the market and compile a list of which companies you should be adding to your portfolio, including short and longer-term positions. Here are the best stocks to buy right now

CFDs are complex instruments and come with a high risk of losing money rapidly due to leverage . 75 % of retail investor accounts lose money when trading CFDs with this provider . You should consider whether you understand how CFDs work, and whether you can afford to take the high risk of losing your money .