Sesen Bio, Inc. (SESN) shares are falling on Monday morning trade after the FDA determined that it cannot approve the BLA for Vicineum in its present form and has provided additional clinical/statistical data recommendations in addition to chemistry, manufacturing, and controls issues.
The Company plans to request a Type A meeting as soon as possible with the FDA to discuss the next steps for the compound intended for patients suffering from BCG-unresponsive NMIBC. Sesen Bio CEO said, "we are deeply disappointed by this unexpected result."
Sesen Bio shares are currently at $1.35, down 36.01 percent from the previous close of $2.11 on a volume of 53,021,158. For the 52-week period, the shares have traded in a range of $0.70-$6.04 on average volume of 9,078,320.
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