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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 reported net revenue of $16.2 million for Q3 2022, with $7.4 million from KORSUVA® injection profit-sharing. The company witnessed a significant demand increase, shipping approximately 184,440 vials during the quarter. An FDA meeting is scheduled for Q4 2022 to discuss a potential pivotal program for notalgia paresthetica. However, the net loss widened to $23.2 million from $1.0 million in Q3 2021. Cash reserves decreased to $179.5 million due to higher operational costs, but guidance suggests adequate funding through the first half of 2024.
Cara Therapeutics (Nasdaq: CARA) has appointed Lisa von Moltke, M.D., to its Board of Directors, enhancing its clinical development expertise. Dr. von Moltke, who is currently the Chief Medical Officer at Seres Therapeutics, brings significant experience from previous roles at Alkermes, Sanofi/Genzyme, and Takeda Oncology. Her leadership is expected to support the advancement of oral difelikefalin for treating pruritus. This appointment aligns with Cara's strategy to expand therapeutic applications of its FDA-approved KORSUVA®.
Cara Therapeutics, Inc. (Nasdaq: CARA) announced investor conference presentations by its Executive Leadership Team. Key dates include the Stifel Healthcare Conference on November 15, the Jefferies London Healthcare Conference on November 16, the Evercore ISI Healthcare Conference on November 29, and the Piper Sandler Healthcare Conference on December 1, 2022. Webcasts will be available in the 'Events & Presentations' section of the Cara website, with recordings accessible for 30 days. The company focuses on innovative pruritus treatments, including the FDA-approved KORSUVA®.
Cara Therapeutics, Inc. (Nasdaq: CARA) will host a conference call on November 7, 2022, at 4:30 p.m. ET to discuss third quarter 2022 financial results and provide a corporate update. The company is known for its innovative KORSUVA® (difelikefalin) injection, the first FDA-approved treatment for moderate-to-severe pruritus associated with chronic kidney disease in hemodialysis patients. Cara is also developing an oral version of difelikefalin and has initiated Phase 3 programs for pruritus in non-dialysis dependent advanced chronic kidney disease and atopic dermatitis.
SWK Holdings Corporation announced a $5 million milestone payment received by its subsidiary, Enteris BioPharma, from Cara Therapeutics related to the clinical progress of Oral KORSUVA. This payment stems from the license agreement for the Peptelligence® technology, crucial for the oral formulation of CR845/difelikefalin. Enteris retains $2.5 million of this amount, adding to the previous $33 million received from Cara since the license's inception. Enteris remains eligible for further milestone payments and royalties based on developmental achievements.
Cara Therapeutics (CARA) has announced that its licensing partner, Maruishi Pharmaceutical, submitted a New Drug Application (NDA) in Japan for difelikefalin, aimed at treating pruritus in hemodialysis patients. The NDA is based on a Phase 3 study with 178 patients showing significant improvement in itch severity compared to placebo. Difelikefalin is already FDA-approved for similar indications in the U.S. The licensing agreement with Maruishi allows Cara to receive milestone payments and royalties from potential sales in Japan.
Cara Therapeutics (CARA) has appointed Ryan Maynard as the new Chief Financial Officer, effective immediately. Maynard's prior experience includes serving as CFO at LetsGetChecked and Rigel Pharmaceuticals, where he significantly contributed to revenue growth and product launches. His role will be pivotal in executing Cara's growth strategy, particularly in maximizing the launch of KORSUVA™ (difelikefalin) and advancing their oral pipeline for chronic pruritus. The company aims to lead in treating chronic pruritus, with various ongoing clinical programs.
Cara Therapeutics announced positive results from the KOMFORT Phase 2 trial of oral difelikefalin for treating moderate-to-severe pruritus in notalgia paresthetica. The study achieved its primary endpoint, showing a significant reduction in itch intensity at Week 8 (p=0.001). Notably, 41% of patients on difelikefalin experienced a ≥4-point improvement in itch scores compared to 18% on placebo (p=0.007). Additionally, 22% of patients achieved a complete response with difelikefalin versus 5% with placebo (p<0.01). The treatment was generally well tolerated with mild to moderate adverse events.
Cara Therapeutics, Inc. (Nasdaq: CARA) has announced that President and CEO Christopher Posner will present at the H.C. Wainwright 24th Annual Global Investment Conference on September 13, 2022, at 8:30 a.m. ET. This event highlights the company's commitment to improving the lives of patients with pruritus. Cara’s KORSUVA™ (difelikefalin) injection is the first FDA-approved treatment for moderate-to-severe pruritus in adults on hemodialysis. The company is also advancing oral formulations and conducting Phase 2 and 3 programs for various pruritus conditions.
Cara Therapeutics announced a virtual event on September 20, 2022, focusing on the treatment of notalgia paresthetica (NP) using oral difelikefalin. This presentation will share data from the KOMFORT Phase 2 clinical trial and feature key opinion leaders discussing the significant unmet clinical need in treating NP. The event will include a live audio webcast and a subsequent Q&A session. Cara Therapeutics is advancing its oral difelikefalin, having already gained FDA approval for its injectable form for chronic pruritus in patients undergoing hemodialysis.
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