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Clovis Oncology spikes; receives early FDA approval for advanced cancer drug

Shares of Clovis Oncology closed up 8.82 percent Monday as the company received early approval for its advanced ovarian cancer drug Rubraca (rucaparib).

The stock was initially up 15 percent to $42.86 before being halted for volatility. After reopening, it continued to climb and jumped as much as 22 percent before paring its gains and finishing the day up less than 9 percent.

Clovis Oncology intraday chart

The U.S. Food and Drug Administration's decision was not expected until February, but was expedited through its accelerated approval program. Specifically, the process allows early approval of a drug to treat a serious or life-threatening disease based on clinical data.

The drug is meant for women with advanced ovarian cancer who have already been treated with two or more chemotherapies. Their tumors also need to have a specific gene mutation that leads to the repair of cancerous cells.

Ovarian cancer will be diagnosed in 22,280 women in 2016, and an estimated 14,240 will die of the disease, according to the National Cancer Institute. The newly approved drug would target about 15 to 20 percent of ovarian cancer patients who have the specific gene mutation, known as deleterious BRCA.

Clovis also was exploring the possibility of using Rubraca to fight other diseases, including prostate, breast and gastroesophageal cancers. The Colorado-based biopharmaceutical company owns the worldwide rights to the drug.


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