{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-098676","form_type":"8-K","ticker":"TRVI","cik":"0001563880","company_name":"Trevi Therapeutics, Inc.","filed_at":"2026-03-09T23:59:59+00:00","discovered_at":"2026-05-14T18:02:35.450452+00:00","generated_at":"2026-05-15T17:41:52.705824+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Trevi Therapeutics gains FDA alignment on Phase 3 plan for nalbuphine ER in IPF cough; first trial Q2 2026","bullets":["End-of-Phase 2 FDA meeting: overall alignment on IPF-related chronic cough development program including two pivotal Phase 3 trials and Phase 1 studies for NDA support.","First Phase 3 trial (~300 patients, 52-week dosing, primary endpoint at 24 weeks) expected to start Q2 2026; second Phase 3 (~130 patients, 12-week dosing) in H2 2026.","Both trials randomized, double-blind, placebo-controlled, global, evaluating nalbuphine ER 54 mg BID vs placebo with 2:1 randomization.","Primary endpoint for both: relative change from baseline in 24-hour cough frequency measured by objective cough monitor.","Trial designs are subject to final FDA protocol review."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-098676","json":"https://secwatch.observer/filing/0001193125-26-098676.json","markdown":"https://secwatch.observer/filing/0001193125-26-098676.md","text":"https://secwatch.observer/filing/0001193125-26-098676.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1563880/000119312526098676/0001193125-26-098676-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1563880/000119312526098676/trvi-20260309.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T17:41:52.705824+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}