Sesen Bio Inc SESN is trading significantly lower Monday after the U.S. Food and Drug Administration issued a Complete Response Letter for the company's bladder cancer candidate Vicineum.
The FDA determined that it cannot approve Sesen Bio's Biologics License Application for Vicineum in its present form and provided recommendations specific to additional clinical and statistical data and analyses.
Sesen Bio plans to request a meeting with the FDA as soon as possible to discuss the next steps that are needed before the application may be approved.
“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," said Thomas Cannell, president and CEO of Sesen Bio.
Sesen Bio is a late-stage clinical company engaged in next-generation antibody-drug conjugate therapies for the treatment of cancer.
Price Action: Sesen Bio has traded as high as $6.04 and as low as 70 cents over a 52-week period.
At last check Monday, the stock was down 36% at $1.35.
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