Regulatory milestones

Gilead Sciences Inc. (NASDAQ:GILD) was up $0.03 to $72.23 on Monday after FDA accepted and granted Priority Review for an NDA for an oral, once-daily, fixed-dose combination of the company's Sovaldi sofosbuvir and ledipasvir (GS-5885) to treat chronic HCV genotype 1 infection. The PDUFA date is Oct. 10. An MAA for the combination is under accelerated assessment in the EU.