Clovis Oncology Inc. shares surged 50% in premarket trade Monday after the company said its late-stage trial for a cancer drug met its primary endpoint and a key secondary endpoint. Clovis said it plans to try for Food and Drug Administration approval for the drug, rucaparib, within the next four months for second line and later maintenance treatment for women with platinum-sensitive ovarian cancer who have responded to their most recent platinum therapy. Leerink analyst Michael Schmidt described the latest results as "bull case plays out." "The outcome looks to be the best-case-scenario for CLVS," he said, adding "the results look particularly impressive when compared to previous competitor data," including companies like Tesaro and AstraZeneca , which are also developing a class of cancer drugs called PARP inhibitors. "If approved, Rubraca would have the broadest label of any PARP inhibitor in ovarian cancer... which we think should bode well for the commercial uptake of the drug," Schmidt said, calling the company a prime takeout candidate. In three sub-groups of women with ovarian, fallopian tube, or primary peritoneal cancer, patients on rucaparib had improved progression-free survival, the phase 3 trial's primary endpoint. Progression-free survival was also improved in patient on the drug as compared with placebo, a key secondary endpoint, Clovis Oncology said. The trial enrolled 564 women. Clovis Oncology shares have dropped 15.9% to $59.97 over the last three months, compared with a 2.3% rise in the S&P 500 .
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