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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) announced results from its KARE Phase 2 clinical trial of oral difelikefalin for treating moderate-to-severe pruritus in atopic dermatitis (AD) patients during the EADV Congress on October 2, 2021. The trial involved 401 subjects over 12 weeks, with a significant improvement in itch observed in the subgroup with BSA <10%. Although the primary endpoint was not met for the overall population, 32% of the difelikefalin group achieved a ≥4-point improvement in itch score. Difelikefalin was well-tolerated with mostly mild adverse events.
Cara Therapeutics (Nasdaq: CARA) announced the presentation of results from the KARE Phase 2 clinical trial of Oral KORSUVA™ for treating moderate-to-severe pruritus in atopic dermatitis patients. This late-breaking presentation will be held at the European Academy of Dermatology and Venereology Congress from September 29-October 2, 2021. The presentation, titled Oral Difelikefalin Reduces Pruritus in Atopic Dermatitis, is scheduled for October 2, 2021, at 10:45 CEST, and will be presented by Dr. Brian S. Kim from Washington University School of Medicine.
Cara Therapeutics, Inc. (Nasdaq: CARA) will participate in a fireside chat at the 2021 Cantor Virtual Global Healthcare Conference on September 28, 2021, at 3:20 p.m. ET. The event will feature Derek Chalmers, Ph.D., D.Sc., President and CEO. A live webcast can be accessed through the company's website, with an archived recording available for 30 days. Cara focuses on developing therapies for pruritus by targeting peripheral kappa opioid receptors. Their leading product, KORSUVA, was approved by the FDA on August 23, 2021, to treat pruritus in adults undergoing hemodialysis.
Cara Therapeutics (Nasdaq:CARA) announced FDA approval for KORSUVA™ (difelikefalin) injection, aimed at treating moderate-to-severe pruritus in chronic kidney disease patients on hemodialysis. This first-in-class kappa opioid receptor agonist received Priority Review, indicating significant therapeutic advancements. The approval is backed by positive data from pivotal phase-III trials, KALM-1 and KALM-2. Cara has partnered with Vifor Pharma for U.S. commercialization, with plans to launch in Q1 2022 and seek timely reimbursement from Medicare. The drug addresses a critical unmet need in CKD-aP patients.
Cara Therapeutics has received FDA approval for KORSUVA™ injection, the first treatment for pruritus associated with chronic kidney disease in adults undergoing hemodialysis. This first-in-class kappa opioid receptor agonist targets the peripheral nervous system. The promotional launch is expected in Q1 2022, with reimbursement anticipated in H1 2022. The approval is based on positive data from pivotal Phase 3 clinical trials, KALM-1 and KALM-2, which showed the product to be generally well tolerated. Vifor Pharma collaborates with Cara for commercializing KORSUVA in the U.S.
Cara Therapeutics reported Q2 2021 financial results, highlighting the New Drug Application (NDA) for KORSUVA™ Injection under Priority Review by the FDA, targeting a PDUFA date of August 23, 2021. The company incurred a net loss of $30.7 million, or $0.61 per share, compared to a loss of $25.1 million in Q2 2020. Revenue was absent for the quarter, down from $5.6 million a year prior. R&D expenses decreased to $25.2 million. Despite cash reserves declining to $207.4 million, the firm expects to fund operations into 2023.
Cara Therapeutics (Nasdaq: CARA) will host a conference call on August 9, 2021, at 4:30 p.m. ET to discuss its second quarter 2021 financial results and provide a corporate update. The live audio webcast will be available on the company’s website, and an archived recording will be accessible shortly after the call. The company is focused on developing treatments for pruritus, particularly with its product KORSUVA, which has shown promise in clinical trials for patients with chronic kidney disease. The FDA has granted Priority Review for KORSUVA's NDA.
SWK Holdings Corporation (Nasdaq: SWKH) announced that its subsidiary, Enteris BioPharma, received a $10 million milestone payment from Cara Therapeutics (Nasdaq: CARA) related to the licensing of Peptelligence technology for Oral KORSUVA. Enteris will retain $3.9 million from this payment. This payment follows the completion of an End-of-Phase 2 Meeting with the FDA regarding Oral KORSUVA for chronic kidney disease. Enteris has previously received milestone payments totaling $5 million and is eligible for more as development milestones are achieved.
Cara Therapeutics (Nasdaq: CARA) has announced Derek Chalmers, CEO, will engage in a fireside chat during the Jefferies Healthcare Conference on June 1, 2021, at 11:00 a.m. ET. Interested parties can watch the live webcast on the company's website, with an archived version available for 30 days post-event. Cara Therapeutics focuses on developing solutions to alleviate pruritus using KORSUVA (CR845/difelikefalin), which has made significant progress in clinical trials and has received FDA Priority Review for moderate-to-severe pruritus treatment.
Cara Therapeutics announced FDA's acceptance of its NDA for KORSUVA™ Injection with Priority Review status, targeting chronic kidney disease-associated pruritus. The expected PDUFA date is August 23, 2021. Financial results show a net loss of $23.3 million for Q1 2021, a decrease from $28.9 million the previous year, but revenues fell to $1.9 million from $8.1 million. The company plans to proceed with Phase 3 studies for various indications, including potential treatments for atopic dermatitis and chronic liver disease-associated pruritus.
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