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.
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.
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