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Cara Therapeutics, Inc. (Nasdaq: CARA) is a pioneering biotechnology company focused on developing innovative treatments for pain, inflammation, and pruritus (itching). The company aims to address unmet medical needs with its proprietary therapeutic approaches and cutting-edge drug screening technology. Cara's flagship compound, CR845, is undergoing clinical trials for acute pain and uremic pruritus, demonstrating analgesic, anti-inflammatory, and antipruritic properties that could serve multiple therapeutic purposes.
Cara Therapeutics has recently made significant strides in its clinical programs. Despite the discontinuation of its clinical trial for pruritus associated with atopic dermatitis, the company remains optimistic about other late-stage clinical programs involving oral difelikefalin for indications such as notalgia paresthetica and chronic kidney disease. The company is also collaborating with HealthCare Royalty to secure financial backing and support for its ongoing and future developments.
Financially, Cara expects to end 2023 with approximately $100 million in cash, bolstered by milestone payments from HealthCare Royalty and efficient management of expenses. The company continues to focus on its goal of bringing first-in-class therapeutics to market, leveraging its proprietary drug-screening technology to expand its pipeline of innovative molecules targeting novel analgesic and anti-inflammatory pathways.
Cara Therapeutics, Inc. (Nasdaq: CARA) will hold a conference call on May 9, 2022, at 4:30 p.m. ET to discuss first quarter 2022 financial results and provide a corporate update. The company is known for its KORSUVA™ injection, the sole FDA-approved treatment for moderate-to-severe pruritus linked to chronic kidney disease in adults undergoing hemodialysis. Cara is also developing an oral version of difelikefalin and has initiated Phase 3 programs targeting pruritus in patients with chronic kidney disease and atopic dermatitis.
On April 28, 2022, the European Commission granted marketing authorization for Kapruvia® (difelikefalin), the first therapy in Europe for treating chronic kidney disease (CKD)-associated pruritus in adult hemodialysis patients. This approval follows the FDA approval of KORSUVA™ in August 2021. The first launches in Europe are expected in the second half of 2022, addressing a significant unmet medical need. The authorization is based on pivotal data from two phase-III trials showing significant improvements in pruritus severity and quality of life for patients.
Cara Therapeutics and Vifor Fresenius Medical Care Renal Pharma announced that the European Commission has granted marketing authorization for Kapruvia® (difelikefalin). This is the first approved therapy for chronic kidney disease-associated pruritus in hemodialysis patients across Europe. Following FDA approval in August 2021, Kapruvia® is set to launch in the second half of 2022. Clinical data from phase-III trials demonstrated significant reductions in pruritus severity and improved quality of life for patients. The drug addresses a substantial unmet need in CKD management.
Cara Therapeutics (Nasdaq: CARA) announced participation by CEO Christopher Posner in a fireside chat at the 21st Annual Needham Virtual Healthcare Conference on April 11, 2022, at 1:30 p.m. ET. Attendees can access the event via the company’s website under 'Events & Presentations,' with an archived recording available for 30 days post-event. Cara is recognized for its FDA-approved KORSUVA™ (difelikefalin) injection, the first treatment for moderate-to-severe pruritus in chronic kidney disease patients undergoing hemodialysis. The company is advancing additional formulations and ongoing clinical trials.
Cara Therapeutics (Nasdaq: CARA) announced the presentation of biomarker data from the KALM-1 and KALM-2 clinical trials for KORSUVA (difelikefalin) at the National Kidney Foundation Spring Clinical Meetings 2022. The poster highlights a reduction in itch intensity correlated with decreased inflammatory markers in patients with chronic kidney disease-associated pruritus undergoing hemodialysis. Presentations will take place on April 7, 2022, with additional posters addressing treatment effects on itch severity and sleep disruption. KORSUVA is the first FDA-approved treatment for this condition.
Cara Therapeutics, Inc. (Nasdaq: CARA) presented late-breaking data at the 2022 AAD Annual Meeting, highlighting the effectiveness of Oral KORSUVA™ (difelikefalin) in treating pruritus and inflammation in patients with moderate-to-severe atopic dermatitis. The KARE Phase 2 trial sub-study involved 40 patients, revealing significant downregulation of pruritus-related genes after 12 weeks of treatment. This indicates difelikefalin's potential as a dual-action therapy, addressing both itch and inflammation. Quality of life improvements were also noted, enhancing the overall treatment landscape for patients.
Cara Therapeutics (NASDAQ: CARA) announced that biomarker data from the KARE Phase 2 clinical trial of Oral KORSUVA™ (difelikefalin) for treating moderate-to-severe pruritus in atopic dermatitis will be presented at the 2022 AAD Annual Meeting on March 26, 2022. The company will also host a virtual R&D event on March 11, 2022, to discuss Phase 3 programs for pruritus in advanced chronic kidney disease and atopic dermatitis. The KORSUVA injection is the first FDA-approved treatment for chronic kidney disease-related pruritus.
Cara Therapeutics reported financial results for Q4 and full-year 2021, highlighting a significant drop in revenue to $0.8 million from $112.1 million year-over-year. The net loss for Q4 was $33.4 million, or $(0.63) per share, compared to a profit in the prior year.
The company is preparing for the U.S. launch of KORSUVA injection in April 2022 and has initiated Phase 3 trials for Oral KORSUVA in chronic kidney disease and atopic dermatitis. Cara's cash reserves stand at $236.8 million, sufficient for operations through 2023.
The Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Kapruvia® (difelikefalin) for treating chronic kidney disease-associated pruritus in hemodialysis patients. This therapy would be the first of its kind in
Cara Therapeutics and Vifor Fresenius Medical Care Renal Pharma announced that the Committee for Medicinal Products for Human Use (CHMP) has recommended approval of Kapruvia® (difelikefalin) for treating chronic kidney disease-associated pruritus (CKD-aP) in hemodialysis patients in Europe. This marks a significant advance as Kapruvia would be the first therapy available for this condition in Europe. An official decision from the European Commission is anticipated in Q2 2022. The drug is already approved in the U.S. under the name KORSUVA™.
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