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How Clovis Scored Big on a Milestone FDA Approval

About 17.26 million shares of Clovis Oncology traded hands today, well above the stock’s average trading volume of roughly 861,217 shares per day.

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Mizuho Securities gave shares of Clovis Oncology Inc a price target of 23 indicating a potential decrease of -0.13% from Clovis Oncology Inc’s current price of 23.03.

sCLVS shares shot up 27.2% on news that the FDA has granted priority review status to the company’s regulatory application for its experimental cancer drug, rucaparib.

Rucaparib is a PARP inhibitors, a new type of medicine that blocks a particular enzyme that’s used by our cells to fix DNA so that tumors can’t survive. Since then, Pfizer has snapped up a rival treatment through its $14 billion Medivation acquisition.

Rucaparib earlier secured a breakthrough therapy designation from the FDA for the proposed indication in April 2015.

President and CEO Patrick J. Mahaffy stated that this approval marks an important milestone for the company. Studies of Clovis’s treatment rucaparib showed 54% of patients with recurring ovarian cancer responded to the treatment. He added that the company looks forward to working with the FDA in the NDA review, and explained that there is a huge need for more therapeutic options for advanced ovarian cancer patients with advanced mutant BRCA.

According to The American Cancer Society, ovarian cancer ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system.

“Recurrent ovarian cancer remains a very hard disease to treat, even among women who carry, or whose tumours have a mutation in the BRCA genes”.

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Clovis Oncology’s application is based on data from 106 patients across 2 trials, including the ARIEL2 study. The patients who were enrolled had already gone through at least two prior chemotherapies, and the median number of prior chemotherapy rounds was three.

Clovis Oncology Inc Stock Spikes as FDA Agrees to Priority Review of Rucaparib’s NDA