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Clovis jumps on Priority Review for rucaparib

August 23, 2016 7:00 AM UTC

Clovis Oncology Inc. (NASDAQ:CLVS) gained $4.93 (27%) to $23.03 on Tuesday after it said FDA accepted and granted Priority Review to an NDA seeking accelerated approval of rucaparib ( CO-338) as monotherapy in patients with germline or somatic BRCA-mutated advanced ovarian cancer who have received multiple prior chemotherapies. Its PDUFA date is Feb. 23, 2017.

The oral inhibitor of PARP-1 and PARP-2 has breakthrough therapy designation from FDA for the indication (see BioCentury Extra, April 6, 2015). ...