FDA accepts Clovis application for new use of Rubraca; shares up

Under Priority Review status, the FDA has accepted Clovis Oncology’s (NASDAQ:CLVS) supplemental marketing application seeking approval to use Rubraca (rucaparib) to treat adult men with recurrent, metastatic BRCA1/2 mutation-positive castration-resistant prostate cancer. The agency’s action date is May 15.

The PARP inhibitor was approved in the U.S. in December 2016 for ovarian cancer.

Shares up 13% premarket on robust volume.

https://seekingalpha.com/news/3531967-fda-accepts-clovis-application-for-new-use-of-rubraca-shares-up-13-premarket