The company plans to request an End-of-Phase 2 meeting with the FDA in Q4 2025 and to initiate a Phase 3 IPF chronic cough program in H1 2026. Trevi ended Q3 2025 with $194.9 million in cash and expects a cash runway into 2028. With multiple clinical programs advancing and strong cash position, Trevi is positioned to move toward commercialization in its lead indication.
Cyborg Score Rationale
Trevi demonstrates solid clinical progress with positive Phase 2b data and FDA runway extending into 2028. However, as a clinical-stage biotech, execution risk remains significant, and the company faces substantial development costs ahead with no approved products generating revenue.
Top Insights
Lead asset Haduvio (nalbuphine ER) has demonstrated clinical efficacy with positive Phase 2b CORAL trial results in IPF chronic cough
Phase 3 initiation planned for H1 2026 with FDA End-of-Phase 2 meeting targeted for Q4 2025
Multiple development programs reduce single-asset risk: IPF chronic cough, refractory chronic cough, and prurigo nodolaris programs ongoing
Strong balance sheet with $194.9M cash and runway into 2028 provides adequate runway for clinical development
Named Competitors
IPF/Chronic Cough Therapeutics — GI and respiratory therapeutics
Lung Disease Treatments — Liver and lung disease focus
Oncology/Pulmonary — Broad therapeutics platform
Recent Developments
(November 2025) Reported Q3 2025 results with $194.9M cash position and positive safety data from Phase 1 IPF safety study
(October 2025) Presented efficacy and safety results from Phase 2b CORAL trial and patient-reported outcomes from Phase 2a RIVER trial at CHEST 2025
(Q2 2025) Announced positive Phase 2b CORAL trial results for Haduvio in chronic cough in IPF patients
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