Cara Therapeutics, Inc. - CARA STOCK NEWS

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.

Cara Therapeutics (CARA) announced a conference call on February 25, 2021, at 4:30 p.m. ET, to discuss its fourth quarter and full year 2020 financial results. Investors can join by dialing (855) 445-2816 (domestic) or (484) 756-4300 (international). The call will also be accessible via a live audio webcast on the company's website. Notably, Cara is advancing KORSUVA™ (difelikefalin) for pruritus treatment, having submitted a New Drug Application (NDA) to the FDA, requesting Priority Review, which could expedite the review process.