Traders should monitor upcoming clinical trial initiations in 2026 as key catalysts; any interim data readouts or regulatory designations (e.g., Breakthrough Therapy) could drive further upside. The lack of current treatment options increases commercial potential if efficacy is confirmed.
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Executive Summary
Trevi Therapeutics announced positive feedback from its End-of-Phase 2 meeting with the FDA, confirming the development path for Haduvio™ (nalbuphine ER) in IPF-related chronic cough. The company plans to initiate two parallel Phase 3 trials in 2026, marking a significant step toward a potential NDA submission for a condition with no approved therapies.
Key Facts
- FDA alignment achieved on Phase 3 trial design and remaining development program for nalbuphine ER in IPF-related chronic cough
- Two pivotal Phase 3 trials planned: one with ~300 patients (52-week dosing, primary endpoint at 24 weeks), another with ~130 patients (12-week dosing)
- First Phase 3 trial on track to initiate in Q2 2026, second in H2 2026
- Primary endpoint for both trials: relative change in 24-hour cough frequency vs. placebo using objective cough monitoring
- No FDA-approved therapies currently exist for IPF-related chronic cough, representing a significant unmet medical need
Financial Impact
Potential path to approval for a first-in-class therapy in a high-unmet-need indication with ~100,000 U.S. patients affected (two-thirds of 150,000 IPF patients)
Risk Factors
- Phase 3 trial results may not replicate prior positive data
- Regulatory delays or protocol disagreements with FDA could push back timelines
- High cash burn risk given upcoming pivotal trials; potential for near-term dilution
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3251724 |
Track record builds as more directional reports settle.
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Jun 11, 2026 16w ago | Institutional Cluster | $13.46 $17.26 | ▲ +28.23% | ▲ +23.84% | $14.12 (+4.90%) |
Jun 11, 2026 16w ago | Institutional Cluster | $13.46 $17.26 | ▲ +28.23% | ▲ +23.84% | $14.12 (+4.90%) |
Apr 21, 2026 23w ago | DEFA14A | $14.80 $19.07 | ▲ +28.85% | ▲ +24.07% | $14.12 (−4.59%) |
Apr 20, 2026 23w ago | Press Release | $14.62 $17.36 | ▲ +18.74% | ▲ +11.84% | $14.12 (−3.42%) |
Apr 17, 2026 23w ago | 424B5 | $15.40 $18.15 | ▼ −17.82% | ▼ −11.05% | $14.12 (+8.31%) |
Apr 17, 2026 24w ago | 8-K | $15.23 $17.91 | ▼ −17.60% | ▼ −11.45% | $14.12 (+7.29%) |
Apr 17, 2026 24w ago | Press Release | $15.23 $17.91 | ▲ +17.60% | ▲ +11.45% | $14.12 (−7.29%) |
Mar 17, 2026 28w ago | Press Release | $10.69 $13.46 | ▲ +25.91% | ▲ +14.39% | $14.12 (+32.09%) |
Mar 10, 2026 29w ago | Press Release | $11.94 $13.45 | ▲ +12.65% | ▲ +1.12% | $14.12 (+18.26%) |
Mar 9, 2026 29w ago | Press Release | $11.70 $13.50 | ▲ +15.38% | ▲ +3.40% | $14.12 (+20.68%) |
US Market Status
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