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Biotech Stocks Facing FDA Decision in April

Clovis Oncology
Clovis Oncology

Clovis Oncology Inc.’s (CLVS) supplemental New Drug Application for Rubraca is under priority review by the FDA, with a decision expected on April 6, 2018.

The Company is seeking expanded approval of Rubraca as maintenance treatment in women with platinum-sensitive recurrent ovarian cancer, regardless of a patient’s BRCA mutation status.

Rubraca, also known as rucaparib, was first approved in December 2016 for the treatment of women with advanced ovarian cancer with a BRCA gene mutation, and who have received two or more prior chemotherapies.

The annual net product revenue for Rubraca was $55.5 million in 2017 compared to $78 thousand in 2016.

CLVS closed Tuesday’s (Mar.27) trading at $53.67, down 4.84%.