secwatch.observer — SEC 8-K summary ====================================== Issuer: Tvardi Therapeutics, Inc. (TVRD) CIK: 0001346830 Form: 8-K Filed at: 2024-06-12T23:59:59+00:00 Accession: 0001104659-24-070914 Event type: other_material Sentiment: negative Materiality: 0.85 Item codes: 7.01, 8.01, 9.01 LLM model: deepseek-v4-flash:cloud@v2 Cara Therapeutics discontinues NP program after oral difelikefalin fails Part A of KOURAGE-1 study -------------------------------------------------------------------------------- - Oral difelikefalin did not demonstrate meaningful clinical benefit at any dose vs. placebo in Part A of KOURAGE-1 study for notalgia paresthetica. - Company discontinues clinical program in NP and will explore strategic alternatives to maximize shareholder value. - Cash, cash equivalents, and marketable securities were approximately $70 million as of March 31, 2024. - Drug was well tolerated; safety profile similar to prior trials. Part A enrolled 214 patients across four arms. Source: EDGAR index: https://www.sec.gov/Archives/edgar/data/1346830/000110465924070914/0001104659-24-070914-index.htm Primary doc: https://www.sec.gov/Archives/edgar/data/1346830/000110465924070914/tm2416682d3_8k.htm HTML page: https://secwatch.observer/filing/0001104659-24-070914 License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer