Clovis Oncology stock rises 10% after 'breakthrough' designation from FDA

Clovis Oncology Inc. shares rose nearly 10% in Tuesday morning trade after the company's cancer drug Rubraca got a "breakthrough therapy" designation from the Food and Drug Administration. The designation could expedite the development and review of Rubraca by the FDA for BRCA1/2-mutated metastatic castration-resistant prostate cancer. The company plans to present data from the phase 2 trial, called Triton2, which "served as the basis of our [breakthrough therapy designation] at the [European Society for Medical Oncology] conference later this month," Clovis Chief Executive Patrick Mahaffy said. The FDA designation "hints at efficacy ahead of TRITON2 data," RBC Capital Markets analyst Kennen MacKay said, noting that investor concerns about the data prompted the stock to sell off after earnings. (Clovis shares dropped 10.7%, 8.4% and nearly 4% in the three days after its second-quarter earnings release on August 1.) Metastatic castration-resistant prostate cancer refers to a type of cancer that has spread beyond the prostate and continues to spread in spite of treatments intended to manage the disease. Called mCRPC, it is incurable and usually associated with poor prognosis, according to Clovis. Clovis is also testing Rubraca in a number of other types of cancer, including in combination with a Bristol-Myers Squibb immunotherapy; Rubraca has not been approved in the U.S. Clovis shares have dropped 28.3% over the last three months, compared with a 7.1% rise in the S&P 500 and a 9.7% rise in the Dow Jones Industrial Average .

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