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About Cara Therapeutics
Cara Therapeutics, Inc. (NASDAQ: CARA) is a biopharmaceutical company pioneering the development of novel therapies to address significant unmet needs in the treatment of pain, inflammation, and pruritus. Headquartered in the United States, Cara leverages its proprietary drug screening technology to create first-in-class molecules targeting innovative pathways. The company's mission is to transform how pruritus and related conditions are managed, offering patients safer and more effective treatment options.
Core Business Areas
Cara Therapeutics focuses on the development and commercialization of therapeutics for conditions that are often underserved by existing treatments. Its most advanced compound, difelikefalin, is a first-in-class kappa opioid receptor agonist with demonstrated analgesic, anti-inflammatory, and antipruritic properties. The company has developed both intravenous (IV) and oral formulations of difelikefalin, targeting distinct patient populations and therapeutic needs.
The IV formulation of difelikefalin is approved in the United States, European Union, and several other countries for the treatment of moderate-to-severe pruritus associated with chronic kidney disease in adults undergoing hemodialysis. This formulation is out-licensed globally, reflecting Cara’s strategy to expand its reach through strategic partnerships. Meanwhile, the oral formulation is undergoing clinical trials for additional indications, including pruritus associated with notalgia paresthetica (NP), a sensory neuropathy characterized by chronic itching.
Innovative Pipeline and Proprietary Technology
Cara’s proprietary drug screening platform underpins its commitment to innovation. This technology enables the identification and development of novel compounds targeting pain and inflammation pathways that are distinct from traditional opioid-based therapies. By focusing on kappa opioid receptors, Cara aims to minimize the risks associated with conventional opioids, such as addiction and respiratory depression, while delivering effective relief for patients.
Beyond difelikefalin, Cara is actively exploring additional first-in-class molecules to expand its pipeline. These efforts are aimed at addressing a broader range of conditions associated with pain and inflammation, further solidifying the company’s position as a leader in this niche segment of the biopharmaceutical industry.
Market Position and Competitive Landscape
Cara Therapeutics operates within the competitive and highly regulated biopharmaceutical sector. The company differentiates itself by focusing on pruritus, a condition that has historically been underdiagnosed and undertreated, despite its significant impact on patient quality of life. This focus positions Cara as a trailblazer in addressing a critical gap in medical dermatology and sensory neuropathy.
Key competitors include pharmaceutical companies developing treatments for pain and pruritus, as well as those with broader dermatology portfolios. Cara’s emphasis on kappa opioid receptor agonists and its proprietary technology provide a unique competitive edge, enabling it to offer therapies that are both effective and safer than traditional options.
Strategic Vision
Looking ahead, Cara Therapeutics aims to expand its therapeutic footprint by advancing its clinical pipeline and exploring new indications for its existing compounds. The company’s dual strategy of in-house development and out-licensing ensures a diversified approach to revenue generation and market penetration. By maintaining a strong focus on innovation and addressing unmet medical needs, Cara continues to build its reputation as a trusted name in biopharmaceutical innovation.
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.
Cara Therapeutics, Inc. (Nasdaq: CARA) will have its President and CEO, Derek Chalmers, participate in a fireside chat at the BofA Securities 2021 Virtual Health Care Conference on May 13, 2021, at 11:00 a.m. ET. Investors can access a live webcast on the company's website, with an archived version available for 30 days post-event. Cara focuses on developing treatments for pruritus, with its lead candidate, KORSUVA™ (difelikefalin), showing significant results in Phase 3 trials. The FDA has set a target action date of August 23, 2021, for KORSUVA's NDA.
Cara Therapeutics, Inc. (Nasdaq: CARA) announced a conference call for May 10, 2021, at 4:30 p.m. ET to report first quarter 2021 financial results and company updates. Interested parties can join the call by dialing (855) 445-2816 or through the live audio webcast on the company's website. Cara is advancing KORSUVA™ (CR845/difelikefalin), a first-in-class KOR agonist targeting pruritus, with two Phase 3 trials showing significant itch reduction in CKD patients. The FDA has accepted the NDA for KORSUVA with a target action date of August 23, 2021.
Cara Therapeutics (CARA) announced the results of its KARE Phase 2 clinical trial for Oral KORSUVA (difelikefalin), targeting moderate-to-severe pruritus in atopic dermatitis (AD) patients. The trial enrolled 401 participants, but it did not achieve its primary endpoint for the overall population. However, significant improvements were noted in the mild-to-moderate AD subgroup, with 32% of patients showing a ≥4-point reduction in itching vs. 19% in placebo (p=0.033). KORSUVA was well tolerated, and the company plans to discuss registration with the FDA soon.
Cara Therapeutics, Inc. (Nasdaq: CARA) will have its CEO, Derek Chalmers, participate in a fireside chat at the 20th Annual Needham Healthcare Conference on April 14, 2021, at 2:15 p.m. ET. Attendees can access a live webcast via the company's website, with an archived replay available for 30 days. The company is focused on developing treatments for pruritus by targeting peripheral kappa opioid receptors, having advanced KORSUVA™ for moderate-to-severe pruritus in hemodialysis patients, with a PDUFA date set for August 23, 2021.
Cara Therapeutics, Inc. (Nasdaq: CARA) will hold a virtual R&D event on April 7, 2021, from 1:00 p.m. to 3:00 p.m. ET. This event will showcase KORSUVA™ (difelikefalin), a first-in-class KOR agonist aimed at treating chronic pruritus across various indications. Notable presenters include Dr. Brian Kim and Dr. Mark Lebwohl. Attendees can access a live audio webcast through Cara's website, which will later include a replay. KORSUVA has shown significant results in Phase 3 trials for chronic kidney disease-related itching and is under FDA Priority Review with a target action date of August 23, 2021.
Cara Therapeutics and Vifor Fresenius Medical Care Renal Pharma have submitted a Marketing Authorization Application (MAA) for difelikefalin to the European Medicines Agency (EMA). If approved, this injection will be the first treatment for pruritus associated with chronic kidney disease in hemodialysis patients in Europe. The application is backed by positive data from pivotal phase-III trials, KALM-1 and KALM-2, and a total of 32 studies. The EMA’s decision is anticipated in Q2 2022, marking a significant step toward addressing an underdiagnosed condition in kidney patients.
The FDA has accepted the New Drug Application (NDA) for KORSUVA™ (difelikefalin) from Cara Therapeutics (Nasdaq:CARA), granting it Priority Review with a PDUFA target action date of August 23, 2021. If approved, KORSUVA would become the first treatment for moderate-to-severe pruritus in hemodialysis patients. The NDA is supported by positive results from two pivotal Phase 3 trials, KALM-1 and KALM-2, alongside additional supportive studies. The product aims to address the significant unmet medical need for patients suffering from this debilitating condition.
Vifor Pharma and Cara Therapeutics announced that the FDA has accepted and granted Priority Review for the New Drug Application for KORSUVA™ injection aimed at treating moderate-to-severe pruritus in hemodialysis patients. The PDUFA target action date is August 23, 2021. The FDA’s Priority Review designation indicates KORSUVA may offer significant therapeutic advancements compared to standard treatments. This decision follows positive outcomes from pivotal phase-III trials KALM-1 and KALM-2, impacting up to 40% of dialysis patients suffering from this debilitating condition.
Cara Therapeutics announced the FDA's acceptance of the NDA filing for KORSUVA Injection targeting moderate-to-severe pruritus in hemodialysis patients. This marks a potential first treatment for CKD-associated pruritus. In 2020, the company reported a net income of $78.9 million with total revenues of $112.1 million, a substantial increase from $4.5 million in Q4 2019. Furthermore, an agreement with Vifor provides Cara with significant upfront payments and profit-sharing opportunities. Upcoming data releases in 2021 for KORSUVA programs and other indications are eagerly anticipated.
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