See Why Cara Therapeutics (CARA) Stock Is Moving Higher On Tuesday

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  • The FDA has approved Cara Therapeutics Inc CARA and Vifor Pharma AG’s Korsuva (difelikefalin) injection for severe-to-moderate pruritis (itching) in patients with chronic kidney disease (CKD) undergoing dialysis.
  • Difelikefalin is an opioid agonist that targets the kappa opioid receptor in the peripheral nervous system.
  • The companies expect to launch Korsuva in Q1 of 2022 and hope to gain reimbursement and patient access through Medicare and Medicaid in 1H of 2022.
  • Related content: Benzinga's Full FDA Calendar
  • The nod was based on two Phase 3 studies of 1,300 CKD dialysis patients with moderate-to-severe pruritis, which showed that 40% and 37% of Korsuva recipients logged a four-point improvement from baseline on a measure of their most severe itch compared to 21% and 26% for those who received placebo.
  • The drug’s data package included results from an additional 32 trials.
  • Price Action: CARA shares are up 22.2% at $17.45 during the premarket session on the last check Tuesday.
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Posted In: BiotechLong IdeasNewsHealth CareSmall CapFDAMoversTrading IdeasGeneralBriefsChronic Kidney Disease
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