BOULDER — Clovis Oncology Inc.’s stock price soared as much as 26 percent Monday, after word that the U.S. Food and Drug Administration had approved its Rubraca (rucaparib) tablets for treatment of ovarian cancer.
Trading in Clovis was halted temporarily due to the spike, but trading resumed Monday afternoon.
Clovis shares reached almost $47 but had settled down to $41.22 as of 12:40 p.m. Mountain Time, up 10.81 percent.
News of the FDA approval came as a surprise to many analysts, as a ruling was not expected until February.
“We believe that today’s approval of Rubraca provides an important new therapy for advanced ovarian cancer patients …” said Patrick J. Mahaffy, chief executive and president of Clovis Oncology. “We look forward to launching Rubraca with the support of our established U.S. commercial and medical affairs organizations and bringing this much-needed precision medicine to women with advanced ovarian cancer as quickly as possible.”
Rubraca was approved under the FDA’s accelerated approval program, allowing for earlier approval of drugs that treat serious conditions and that fill an unmet medical need. The FDA approved Rubraca for patients who have been treated with two or more chemotherapies and selected for therapy based on an FDA-approved companion diagnostic test. It’s available to patients who have tumors with a genetic mutation called “deleterious BRCA.”
Clovis reported a loss of $65.6 million, or $1.70 per share for its third quarter that ended Sept. 30, and a loss of $278.4 million, or $7.24 per share, for the first nine months of the year.