Core Insights - Cara Therapeutics announced disappointing results from its KOURAGE-1 study, indicating that none of the tested doses of oral difelikefalin showed meaningful clinical benefit over placebo [1][6] - Following the announcement, CARA stock experienced a significant decline of 26.7% on Thursday, contributing to a year-to-date drop of 10.6% [2][5] Company Developments - The company plans to wind down the Phase 2/3 clinical program in neuropathic pain (NP) and is exploring strategic alternatives to maximize shareholder value, which raises concerns about its future viability [6][8] - There is speculation that the company may face bankruptcy or consider selling parts or all of its business due to the poor clinical trial results [8]

Core Insights - Cara Therapeutics announced that oral difelikefalin did not show meaningful clinical benefit compared to placebo in the KOURAGE-1 Part A study, leading to the decision to discontinue the clinical program for notalgia paresthetica (NP) [3][4][8] Company Overview - Cara Therapeutics is a development-stage biopharmaceutical company focused on improving the lives of patients suffering from pruritus, with an IV formulation of difelikefalin approved for treating moderate-to-severe pruritus associated with advanced chronic kidney disease in adults undergoing hemodialysis [2] Clinical Study Details - The KOURAGE-1 Part A study was a multicenter, randomized, double-blind, placebo-controlled trial involving 214 patients, assessing the efficacy of oral difelikefalin at doses of 2 mg, 1 mg, and 0.25 mg twice daily over 8 weeks [1] - The primary endpoint was the proportion of patients achieving a ≥4-point improvement in the weekly mean of the daily 24-hour Itch-Numeric Rating Scale (I-NRS) score at Week 8 [1] Financial Position - As of March 31, 2024, the company reported approximately $70 million in cash, cash equivalents, and marketable securities [9] Future Directions - Following the disappointing results, the company plans to wind down the Phase 2/3 clinical program in NP and explore strategic alternatives to maximize shareholder value [8]

– Oral difelikefalin did not demonstrate meaningful clinical benefit compared to placebo – STAMFORD, Conn., June 12, 2024 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a development-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced the outcome from the dose-finding Part A of the KOURAGE1 study evaluating the efficacy and safety of oral difelikefalin for moderate-to-severe pruritus in adult patients with no ...

Cara Therapeutics (CARA) came out with a quarterly loss of $0.56 per share versus the Zacks Consensus Estimate of a loss of $0.38. This compares to loss of $0.49 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -47.37%. A quarter ago, it was expected that this biotechnology company would post a loss of $0.57 per share when it actually produced a loss of $0.59, delivering a surprise of -3.51%. Over the last four quarters, the c ...

● the length of time required to enroll eligible patients; ● the number of doses that patients receive; ● the drop-out or discontinuation rates of patients; ● potential additional safety monitoring or other studies requested by regulatory agencies; ● the duration of patient follow-up; and ● the efficacy and safety profile of the product candidate. injection commenced on April 1, 2024. The unfavorable CMS reimbursement codified in the final CY2024 4l Table of Contents In addition, the probability of success ...

– Topline ef icacy and safety results from KOURAGE 1 Part A portion of notalgia paresthetica (NP) pivotal program now expected by the end of 2Q24 – In March 2024, the Company hosted a virtual event, Meet the NP Experts, featuring a panel of leading dermatologists and key opinion leaders to discuss the unmet need in NP and the potential of oral difelikefalin. A replay of the webcast is available under "Events & Presentations" in the Investors section of the Company's website, www.CaraTherapeutics.com. First ...

"Our notalgia paresthetica (NP) pivotal clinical program is progressing ahead of schedule and we now expect to report topline efficacy and safety results from KOURAGE 1 Part A by the end of the second quarter of 2024," said Christopher Posner, President and Chief Executive Officer of Cara Therapeutics. "We believe the medical dermatology community's interest in our clinical program underscores the significant unmet need for an effective and safe anti-pruritic treatment for the sizeable NP patient population ...

STAMFORD, Conn., May 06, 2024 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (NASDAQ:CARA), a development-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced the Company will report first quarter 2024 financial results on Monday, May 13, 2024, after the U.S. markets close. The press release will be available under "Press Releases" in the Investors section of the Company's website at www.CaraTherapeutics.com. About Cara Thera ...

Cara Therapeutics to Present at the 23rd Annual Needham Virtual Healthcare ConferenceCara Therapeutics, Inc. (Nasdaq: CARA), a development-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced that Christopher Posner, President and Chief Executive Officer, will present at the 23rd Annual Needham Virtual Healthcare Conference on Tuesday, April 9, 2024, at 8:40 a.m. EDT.A webcast of the presentation can be accessed under “Eve ...

STAMFORD, Conn., April 02, 2024 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (NASDAQ:CARA), a development-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced that Christopher Posner, President and Chief Executive Officer, will present at the 23rd Annual Needham Virtual Healthcare Conference on Tuesday, April 9, 2024, at 8:40 a.m. EDT. A webcast of the presentation can be accessed under "Events & Presentations" in the Inves ...