Business
Cara Therapeutics Announces Fourth Quarter and Full Year 2023 Financial Results
–Announced prioritization of clinical programs to focus on late-stage development of oral difelikefalin for notalgia paresthetica (NP)– –Completed enrollment
About this update from Tvardi Therapeutics, Inc.
[{"type":"text","content":"–Announced prioritization of clinical programs to focus on late-stage development of oral difelikefalin for notalgia paresthetica (NP)– –Completed enrollment of KOURAGE 1 Part A portion of NP pivotal program ahead of schedule; topline efficacy and safety results now expected in 3Q24– –Extended cash runway into 2026 with clinical prioritization strategy and reduction in force– –Conference call today at 4:30 p.m. EST– STAMFORD, Conn., March 04, 2024 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a development-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced financial results and operational highlights for the fourth quarter and full year ended December 31, 2023. “Earlier this year, we announced the decision to focus all our resources on our late-stage notalgia paresthetica (NP) clinical program, which we believe puts us on the path to significant near-term value creation,” said Christopher Posner, President and Chief Executive Officer of Cara Therapeutics. “We completed enrollment in KOURAGE 1 Part A, the dose-finding portion of our pivotal program, earlier than anticipated and now expect to report topline efficacy and safety results in the third quarter of 2024. With a sizeable patient population and no approved or effective therapies on the market, we are excited about the commercial potential for oral difelikefalin in NP. Importantly, our cash runway into 2026 gives us the resources necessary to reach all potential key value-inflection milestones in our NP clinical program.” 2023 and Recent Highlights Completed enrollment in KOURAGE 1 Part A with 214 patientsPrioritized late-stage NP clinical program, extending cash runway into 2026Entered into Royalty Purchase and Sale Agreement with HealthCare Royalty for up to $40 million and received $37.5 million, less $1.0 million of transaction costs and advisory fees, in 4Q23CY 2024 End Stage Renal Disease Prospective Payment System (ESRD PPS) final rule issued by CMS outlining post-TDAPA reimbursementHelen M. Boudreau appointed to the Company’s Board of Directors and serving as Chair of the Audit CommitteeResults from the KOMFORT Phase 2 proof-of-concept study of oral difelikefalin in NP published in the New England Journal of Medicine KOURAGE Update In the first quarter of 2024, the ...