Cara Therapeutics, Inc. - CARA STOCK NEWS

Cara Therapeutics (Nasdaq: CARA) will present at the 39th Annual J.P. Morgan Healthcare Conference on January 13, 2021, at 2:00 p.m. ET. CEO Derek Chalmers will lead the presentation, which can be accessed via a live webcast on the Cara Therapeutics website. The company focuses on developing KORSUVA™ (CR845/difelikefalin), targeting peripheral kappa opioid receptors to alleviate pruritus, particularly in hemodialysis patients. KORSUVA Injection has received Breakthrough Therapy Designation from the FDA, with a New Drug Application submitted for review.

Cara Therapeutics has submitted its first New Drug Application (NDA) for KORSUVA™ Injection (difelikefalin) to the FDA, targeting moderate-to-severe pruritus in hemodialysis patients. The submission includes a request for Priority Review under Breakthrough Therapy Designation, potentially expediting the review process. Supported by positive data from pivotal Phase 3 trials, the NDA could lead to a six-month review if accepted. This milestone is significant for patients suffering from chronic kidney disease-associated pruritus, which severely impacts their quality of life.

Cara Therapeutics (CARA) announced the completion of full enrollment in its KARE Phase 2 clinical trial for Oral KORSUVA™, targeting moderate-to-severe pruritus in atopic dermatitis patients. The trial enrolled 400 patients across the U.S., surpassing the original target of 320 to ensure optimal statistical power. Topline data is expected in the first half of 2021, marking a significant milestone. The efficacy and safety of Oral KORSUVA will be assessed over a 12-week period, alongside a 4-week extension phase. This development is crucial in addressing unmet medical needs in pruritus treatment.

Cara Therapeutics (Nasdaq: CARA) announced that Dr. Derek Chalmers, its CEO, will participate in several virtual investor conferences in November and December 2020. Key events include the Stifel 2020 Virtual Healthcare Conference (Nov 16-18), Jefferies Virtual London Healthcare Conference (Nov 17-19), and Piper Sandler Virtual Healthcare Conference (Dec 1-3). Dr. Chalmers will engage in fireside chats, with recordings accessible on the company's website for 30 days post-event. Cara is focused on new treatments for pruritus through its KORSUVA product line.

Cara Therapeutics (CARA) reported its third-quarter 2020 financial results with a net loss of $16.5 million, improving from a net loss of $32.8 million year-over-year. Total revenue rose to $9.3 million, compared to $5.8 million in Q3 2019, mainly from licensing agreements. The company announced significant progress in its KORSUVA programs, including a commercial license agreement with Vifor for KORSUVA Injection and plans for an NDA submission to the FDA in Q4 2020. Cash and cash equivalents stood at $131.4 million, decreased from $218.2 million at year-end 2019, but are expected to fund operations into 2023.

Cara Therapeutics (Nasdaq: CARA) announced a conference call scheduled for November 9, 2020, at 4:30 p.m. ET to discuss its Q3 2020 financial results and provide a corporate update. The call can be accessed through domestic and international phone lines, and a live webcast will be available on the company’s website. Cara focuses on developing treatments for pruritus, particularly KORSUVA™, which has shown promising results in clinical trials targeting kidney disease-associated itching. The FDA has conditionally accepted KORSUVA as the trade name for its investigational drug.

Cara Therapeutics (CARA) announced that results from the KALM-2 pivotal Phase 3 trial of KORSUVA™ Injection will be presented at ASN Kidney Week 2020. The trial achieved its primary and key secondary endpoints, demonstrating significant improvements in itching intensity for hemodialysis patients with chronic kidney disease-associated pruritus. KORSUVA Injection was well-tolerated, with a safety profile consistent with previous trials. The company is on track to submit a New Drug Application for KORSUVA Injection to the FDA in Q4 2020.

Cara Therapeutics has entered a licensing agreement with Vifor Pharma for the commercialization of IV Korsuva in non-Fresenius Medical Care dialysis clinics, covering approximately 66% of the U.S. market. Cara will receive an upfront payment of $100 million and a $50 million equity investment, along with potential milestone payments totaling up to $290 million. The NDA submission for IV Korsuva is expected in Q4 2020. This partnership allows Cara to concentrate on its clinical programs for Oral Korsuva, addressing significant unmet medical needs in chronic kidney disease-associated pruritus.

Cara Therapeutics (Nasdaq: CARA) has appointed Thomas Reilly as its new Chief Financial Officer, effective October 1, 2020. Reilly joins from Allergan, where he managed the U.S. General Medicine Commercial Business. His extensive biopharmaceutical experience is expected to support the advancement of KORSUVA Injection towards its NDA filing. KORSUVA aims to treat pruritus in chronic kidney disease patients and has shown promising results in clinical trials. The company is poised for growth as it transitions into a commercial-stage organization.