Clovis Oncology Shares Soar on Positive FDA News

Shares of biopharmaceutical company Clovis Oncology were soaring on Wednesday after the company said the supplemental new drug application (sNDA) for its prostate cancer treatment Rubraca has been granted priority review status by the Food and Drug Administration.

Rucaparib is an oral, small molecule inhibitor of PARP1, PARP2 and PARP3 being developed in multiple tumor types, including ovarian and metastatic castration-resistant prostate cancers, as monotherapy, and in combination with other anti-cancer agents. Exploratory studies in other tumor types are also underway.

Clovis Oncology shares moved 22% in premarket trading on Wednesday. The company has seen its stock explode 177% in the past three months.

“Recently presented data suggests that Rubraca may play a meaningful role in the treatment of patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer, and this filing represents an important milestone for Clovis as it brings us one step closer to potentially making this valuable therapy available,” said Chief Executive Patrick Mahaffy.

“We are encouraged by the FDA’s decision to grant priority review to the Rubraca application, which focuses on eligible patients with advanced prostate cancer, for whom new treatment options are very much needed.”
The American Cancer Society estimated that more than 175,000 men in the United States would be diagnosed with prostate cancer in 2019, and the GLOBOCAN Cancer Fact Sheets estimated that approximately 450,000 men in Europe were diagnosed with prostate cancer in 2018.

Disclaimer: We have no position in Clovis Oncology Inc. (NASDAQ: CLVS) and have not been compensated for this article.