Clovis shares surge on FDA news

Shares of Boulder-based Clovis Oncology were up on news that the Food and Drug Administration accepted the drugmaker’s application for an accelerated review of rucaparib, a drug to treat advanced ovarian cancer.

The stock surged as much as 27 percent on Tuesday, closing the day at $23.03, up from Monday’s $18.10 close. Shares were trading up again Wednesday morning but finished down 2.91 percent at $22.36.

The medication treats patients who suffer from advanced, mutant ovarian cancer and have been treated with two or more chemotherapies, Clovis said in a statement.

“Recurrent ovarian cancer remains a very difficult disease to treat, even among women who carry or whose tumors have a mutation,” said Robert L. Coleman, one of the principal investigators in the clinical trial.

The FDA granted the company’s new drug application priority review status, with a decision set for Feb. 23.

Priority review speeds up the approval process and is often reserved for therapies treating a group of patients with few other options, Colorado Bioscience Association president April Giles said.

“Assuming FDA approval, it allows that (drug) to go out to market faster,” she said.

In a study of 106 women who had undergone prior chemotherapy, 54 percent of patients responded favorably to the rucaparib treatment.

It was welcome news for Clovis. The company’s stock has been hammered over the past several months since the FDA declined to approve a lung cancer drug, causing Clovis to abandon the project.

In May, the company announced it would lay off 35 percent of its 309-person global workforce. Clovis employs 90 people in Boulder.

Giles said that FDA approval of rucaparib could “absolutely” turn things around for Clovis.

“If Clovis progresses through review and gets full approval, that’s hugely significant not just in Colorado but in drug development across the country,” she said.