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FDA accepts Sesen Bio's plan to ensure flagship drug vicinium’s manufacturing quality; shares jump

Sesen’s Canada facility produced vicinium for its Phase 2 and 3 clinical trials, but FUJIFILM Diosynth Biotechnologies USA will make the drug for commercial use
bladder health
Vicinium treats patients with high-risk, non-muscle invasive bladder cancer

Shares of Sesen Bio (NASDAQ:SESN) jumped by double-digits Tuesday after announcing the Food and Drug Administration has accepted its analytic comparability plan as the company seeks to commercialize its flagship drug vicinium to treat bladder cancer.

The analytic comparability plan is designed to ensure the consistency of vicinium’s manufacturing quality. Sesen’s facility in Winnipeg, Manitoba produced vicinium for its Phase 2 and 3 clinical trials. But FUJIFILM Diosynth Biotechnologies USA will manufacture the drug for commercial use.

Sesen Bio’s stock recently traded up 24% to $2.71 a share on heavier-than-average volume.

READ: Sesen Bio to present Phase 3 data of its bladder cancer drug

Sesen, based in Cambridge, Massachusetts, said in a statement that it met with the FDA on Monday, and no additional clinical studies will be required.

The company said it will meet the FDA again on June 6 to discuss the registration strategy for vicinium, which treats patients with high-risk, non-muscle invasive bladder cancer who have been treated previously with bacillus Calmette-Guérin.

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