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Sesen Bio Stock Skyrockets Ahead of FDA Bladder Cancer Drug Decision

Sesen Bio's stock climbs as the company says it expects to hear from the FDA next week.
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Sesen Bio  (SESN) - Get Sesen Bio, Inc. Report surged Friday to its highest level in five years after the biotech company said it expects a decision from federal regulators next week about its bladder cancer treatment.

Shares of the Cambridge, Mass., company were climbing 21.2% to $5.95. The stock reached its highest intraday level since September 2016.

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Sesen Bio said that in February the Food and Drug Administration accepted the company's Biologics License Application for Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer and granted the application priority review with a target Prescription Drug User Fee Act date of Aug. 18.

"We remain focused on executing a world-class launch in the US if Vicineum is approved, and we also continue to support our partners outside of the United States, as part of our commitment to deliver a therapy we believe can improve patient outcomes globally while reducing overall healthcare costs for patients," Thomas Cannell, president and CEO, said in a statement.

The American Cancer Society estimates there will be about 83,730 new cases of bladder cancer in 2021, with 17,200 deaths.

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Bladder cancer is the fourth most common cancer in men, but it's less common in women, the society said.

BCG refers to Bacillus Calmette-Guerin and is the most common intravesical immunotherapy for treating early-stage bladder cancer.

In addition, Sesen Bio said it believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors.

The company said Vicineum's activity in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s  (AZN) - Get Astrazeneca PLC Sponsored ADR Report immune checkpoint inhibitor durvalumab.

The company said it hired John Knighton as vice president and chief compliance officer, effective Monday, ahead of the FDA decision. He joins Sesen Bio from TherapeuticsMD  (TXMD) - Get TherapeuticsMD, Inc. Report.

On Monday, Sesen Bio posted a wider-than-expected second-quarter loss and missed revenue expectations.