Welcome to our dedicated page for Cara Therapeutic news (Ticker: CARA), a resource for investors and traders seeking the latest updates and insights on Cara Therapeutic stock.
Cara Therapeutics, Inc. (CARA) is a biopharmaceutical company whose public communications focus on pruritus, or chronic itch, and on the development and commercialization of difelikefalin-based therapies. News about Cara Therapeutics often centers on its clinical programs, commercial collaborations, and corporate actions that affect shareholders.
Company press releases describe the development of an IV formulation of difelikefalin, which is approved in the United States, European Union, and multiple other countries for moderate-to-severe pruritus associated with advanced chronic kidney disease in adults undergoing hemodialysis, with this IV formulation out-licensed worldwide. News items also discuss the company’s efforts to develop an oral formulation of difelikefalin for chronic pruritus associated with notalgia paresthetica, including details of the Phase 2/3 KOURAGE clinical program and the outcome of the KOURAGE-1 Part A study.
Investors following CARA-related news will see updates on clinical trial enrollment and readouts, such as announcements that oral difelikefalin did not demonstrate a meaningful clinical benefit compared to placebo in notalgia paresthetica and the resulting decision to discontinue that program. News releases also cover financial results, revenue from KORSUVA injection and related collaborations, and information about royalty and milestone arrangements.
Cara Therapeutics’ news flow additionally includes corporate and capital structure developments, such as reverse stock splits, plans to regain compliance with Nasdaq listing requirements, exploration of strategic alternatives, and a proposed merger with Tvardi Therapeutics, Inc. The company has announced a 1-for-12 reverse stock split and a later 1-for-3 reverse stock split in connection with the proposed merger, with expectations regarding a transition to a new company name and ticker symbol after the anticipated closing of that merger.
This news page allows readers to review these types of updates in one place, including clinical, commercial, financial, and corporate announcements related to Cara Therapeutics and the historical CARA ticker.
Cara Therapeutics has launched KORSUVA™ injection in the U.S. for chronic kidney disease-related pruritus, with early performance meeting expectations. European approval for Kapruvia® triggers a $15M milestone payment. The company reports Q1 2022 revenues of $4.8M, up from $1.9M YoY, but incurs a net loss of $27.7M. R&D and G&A expenses have risen significantly. Ongoing Phase 3 studies for Oral KORSUVA address multiple pruritus indications. Financial guidance indicates funding through H1 2024, bolstered by the recent milestone payment.
Cara Therapeutics (Nasdaq: CARA), a biopharmaceutical company focused on treatments for pruritus, announced that CEO Christopher Posner will present at two investor conferences in May 2022. The first event is the BofA Securities 2022 Healthcare Conference on May 10 at 2 p.m. PT / 5 p.m. ET, followed by the H.C. Wainwright Global Investment Conference on May 25 at 2:30 p.m. ET. Webcasts of the presentations will be available on the company's website for 30 days. Cara is known for its FDA-approved KORSUVA™ (difelikefalin) injection for treating pruritus in chronic kidney disease.
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.