Cara Therapeutics, Inc. - CARA STOCK NEWS

Kapruvia (difelikefalin) has received approval in Switzerland as the first therapy for treating pruritus associated with chronic kidney disease (CKD) in hemodialysis patients. This follows previous approvals in the U.S., EU, UK, and Canada. The approval was based on positive data from two pivotal phase-III trials and other studies. Cara Therapeutics aims to make this treatment accessible globally, addressing a significant unmet medical need in CKD patients suffering from severe itching. Regulatory decisions for Australia and Singapore are expected soon.

Kapruvia® (difelikefalin) has received approval from the Swiss Agency for Therapeutic Products for treating chronic kidney disease (CKD)-associated pruritus in hemodialysis patients. This follows approvals from agencies in the U.S., Canada, and Europe. The approval is backed by positive results from pivotal phase-III trials, including KALM-1 and KALM-2, and 32 supportive studies. Regulatory decisions in Australia and Singapore are anticipated soon. The therapy aims to address a significant unmet medical need for those suffering from moderate-to-severe pruritus, potentially improving their quality of life.

Cara Therapeutics reported $23 million in net revenue for Q2 2022, driven by $8 million from KORSUVA injection profit-sharing and a $15 million milestone from the European Commission approval of Kapruvia. The KOMFORT Phase 2 trial for oral difelikefalin in treating notalgia paresthetica met its primary endpoint, leading to a planned FDA meeting in H2 2022. The company ended Q2 with $204.7 million in cash and equivalents. While R&D expenses decreased to $19.9 million, G&A expenses rose to $7.6 million, affecting net loss, which narrowed to $4.2 million, or $(0.08) per share.

Cara Therapeutics (Nasdaq: CARA) will have its CEO, Christopher Posner, present at the Canaccord Genuity 42nd Annual Growth Conference on August 10, 2022, at 9:30 a.m. ET. The presentation will focus on the company's innovative treatment for pruritus, notably its FDA-approved KORSUVA™ injection for kidney disease patients. An archived recording will soon be available on the company’s website for 30 days. Cara is also developing an oral difelikefalin formulation and conducting clinical trials for various pruritus-related conditions.

Cara Therapeutics (Nasdaq: CARA) will host a conference call on August 8, 2022, at 4:30 p.m. ET to discuss its Q2 2022 financial results and provide a corporate update. The call will be available via audio webcast, with a replay accessible on the company's website. Cara Therapeutics specializes in developing treatments for pruritus, notably with KORSUVA™ (difelikefalin) injection, the first FDA-approved treatment for moderate-to-severe pruritus in kidney disease patients undergoing hemodialysis. The company is also advancing oral formulations for other conditions.

Cara Therapeutics announced positive topline results from its Phase 2 trial evaluating oral difelikefalin for treating moderate-to-severe pruritus associated with notalgia paresthetica. The study met its primary endpoint, showing a significant change in the Worst Itch-Numeric Rating Scale score by Week 8 (p=0.001). Results indicated an early onset of action by Week 1, sustained through Week 8, and a favorable safety profile. With no existing approved treatments for notalgia paresthetica, these findings represent a potential breakthrough in managing this condition.

Cara Therapeutics (Nasdaq: CARA) announced that its CEO, Christopher Posner, will present at two upcoming investor conferences. The H.C. Wainwright Global Investment Conference is scheduled for May 25, 2022, at 10:30 a.m. ET, followed by the Jefferies Healthcare Conference on June 8, 2022, at 3:30 p.m. ET. Investors can access webcasts of these presentations on the company's website under 'Events & Presentations.' Cara is known for its FDA-approved treatment, KORSUVA™, aimed at alleviating pruritus in patients with chronic kidney disease.

Cara Therapeutics has launched KORSUVA™ injection in the U.S. for chronic kidney disease-related pruritus, with early performance meeting expectations. European approval for Kapruvia® triggers a $15M milestone payment. The company reports Q1 2022 revenues of $4.8M, up from $1.9M YoY, but incurs a net loss of $27.7M. R&D and G&A expenses have risen significantly. Ongoing Phase 3 studies for Oral KORSUVA address multiple pruritus indications. Financial guidance indicates funding through H1 2024, bolstered by the recent milestone payment.

Cara Therapeutics (Nasdaq: CARA), a biopharmaceutical company focused on treatments for pruritus, announced that CEO Christopher Posner will present at two investor conferences in May 2022. The first event is the BofA Securities 2022 Healthcare Conference on May 10 at 2 p.m. PT / 5 p.m. ET, followed by the H.C. Wainwright Global Investment Conference on May 25 at 2:30 p.m. ET. Webcasts of the presentations will be available on the company's website for 30 days. Cara is known for its FDA-approved KORSUVA™ (difelikefalin) injection for treating pruritus in chronic kidney disease.