TRVI Trevi Therapeutics, Inc.
FY2025 10-K
Trevi Therapeutics, Inc. (TRVI) filed its fiscal year 2025 10-K annual report with the SEC on Mar 17, 2026. This page provides AI-powered analysis of the filing, including business overview, management discussion, risk factors, and key financial metrics from XBRL data.
AI Filing AnalysisFY2025 10-K
Business Overview
- • Core business: Clinical-stage biopharmaceutical developing oral nalbuphine ER (Haduvio) for chronic cough in IPF, non-IPF ILD, and refractory chronic cough patients
- • New emphasis: Initiation of two pivotal Phase 3 trials for IPF-related chronic cough in 2026 after positive Phase 2b CORAL results showing 47.9%-60.2% reduction in cough frequency
Management Discussion & Analysis
- • Revenue $0, no change YoY; no commercial product sales reported
- • Net loss $130M, operating margin not applicable due to no revenues
Risk Factors
- • Regulatory risk: ongoing FDA review of Phase 3 trials for Haduvio dosing; first trial to enroll ~300 patients starting Q2 2026
- • Geopolitical/macro risk: planned Phase 2b RCC trial across UK, Canada, and Europe, subject to international regulatory approvals
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