Cara Therapeutics (NASDAQ:CARA) announces positive topline results from a Phase 3 clinical trial, KALM-1, evaluating KORSUVA (difelikefalin) Injection in hemodialysis patients with moderate-to-severe chronic kidney disease-associated pruritis (itchy skin).
KORSUVA demonstrated a statistically significant separation from placebo after one week of treatment that was sustained through 12 weeks.
Results from a second Phase 3, KALM-2, should be available in H2. If all goes well, a U.S. marketing application will be filed “as quickly as possible.”
Shares, currently halted, will resume trading at 7:30 am ET.
Update: Shares are up 17% premarket on average volume.
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