Cara Therapeutics Inc. (NASDAQ: CARA) stock gained by 4.23% at last close while the CARA stock price surges by 26.05% in the after-hours trading session. Cara Therapeutics is a clinical-stage pharmaceutical business focusing on discovering and selling novel chemical entities that address peripheral kappa opioid receptors, or KORs, to relieve pruritus.
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CARA stock Significant Development
KORSUVA (difelikefalin) for injection has been authorized by the US Food and Drug Administration to treat mild-to-severe pruritus linked with chronic kidney disease in people receiving hemodialysis, according to Cara Therapeutics. KORSUVA injectable is a first-in-class kappa opioid receptor (KOR) agonist for the peripheral nervous system. The FDA granted Priority Review to the KORSUVA injectable new drug application (NDA). It is contingent on the fact that, if authorized, the therapy will provide significant advances in the safety or efficacy of the treatment, diagnosis, or prevention of severe diseases when compared to existing treatments.
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Positive findings from two key Phase 3 trials – KALM-1, conducted in the United States (New England Journal of Medicine 2020; 382:222-232), and the worldwide KALM-2 – as well as supporting data from an additional 32 clinical investigations, led to its clearance. The injection of KORSUVA was typically well-tolerated.
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In the United States, Vifor Pharma and Cara have signed to an exclusive license to sell KORSUVA. In non-Fresenius Medical Care clinics in the United States, that deal includes a 60 percent Cara, 40 percent Vifor Pharma profit-sharing structure. Vifor Fresenius Medical Care Renal Pharma and Cara Therapeutics previously agreed to offer KORSUVA injectable to Fresenius Medical Care North America dialysis clinics in the United States under a Cara 50%, Vifor Pharma 50% profit-sharing deal.
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To guarantee prompt reimbursement and patient access to KORSUVA injectable, Vifor Pharma and Cara Therapeutics are in the process of submitting the appropriate documents to the US Centers for Medicare and Medicaid Services. Vifor Pharma anticipates starting to promote KORSUVA Injection in Q1 2022, with reimbursement expected in H1 2022, depends on CMS timeline.