Announced positive top-line results from its KALM-2 global pivotal Phase 3 trial of KORSUVA Injection in hemodialysis patients with moderate-to-severe CKD-aP.

Trial met the primary endpoint, with a statistically significant proportion of patients on KORSUVA Injection achieving a three-point or greater improvement in the weekly mean Worst Itching Intensity Numeric Rating Scale (NRS) versus placebo (p=0.02) at week 12.

The Company remains on track to submit an NDA to the U.S. Food and Drug Administration (FDA) for KORSUVA Injection in the second half of 2020.

The Company remains on track to conduct an End of Phase 2 Meeting with the FDA to enable initiation of a Phase 3 program in the second half of 2020.