Trevi Therapeutics Reports Fourth Quarter and Year End 2025 Financial Results and Provides Business Updates
Rhea-AI Summary
Trevi Therapeutics (Nasdaq: TRVI) reported year-end 2025 results and clinical updates on March 17, 2026. The company ended 2025 with $188.3 million in cash and expects runway into 2028. Trevi gained FDA alignment after an End-of-Phase 2 meeting for IPF-related chronic cough and plans two Phase 3 trials, a Phase 2b RCC trial in Q2 2026, and a Phase 2b non‑IPF ILD trial in H2 2026.
Key financials: 4Q25 net loss of $8.3M; full-year 2025 net loss of $42.8M; R&D $33.5M; G&A $15.9M. Management will host a conference call and an Investor Day on May 7, 2026.
Positive
- FDA End-of-Phase 2 alignment for IPF-related chronic cough
- Two pivotal Phase 3 trials planned in 2026
- Phase 3 first trial sized ~300 patients, primary endpoint at 24 weeks
- Cash balance of $188.3M with runway into 2028
- Phase 2b CORAL results published in JAMA in January 2026
Negative
- G&A expenses increased to $15.9M in 2025
- Full-year net loss of $42.8M for 2025
News Market Reaction – TRVI
On the day this news was published, TRVI declined 4.47%, reflecting a moderate negative market reaction. Argus tracked a trough of -9.5% from its starting point during tracking. Our momentum scanner triggered 3 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $72M from the company's valuation, bringing the market cap to $1.54B at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
Peers showed mixed, mostly small moves (e.g., DNTH +0.23%, GPCR +0.12%, ELVN -1.79%, LENZ -2.73%), indicating this earnings update is more stock-specific than sector-driven.
Previous Earnings Reports
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 13 | Q3 2025 earnings | Positive | -0.8% | Reported Q3 2025 results, strong cash and Phase 3 planning for IPF cough. |
| Aug 07 | Q2 2025 earnings | Positive | +1.6% | Q2 2025 results plus positive Phase 2b CORAL data and $115M offering. |
| May 08 | Q1 2025 earnings | Positive | +0.0% | Q1 2025 results with positive Phase 2a RIVER data and cash runway update. |
| Mar 18 | Q4 2024 earnings | Positive | +3.8% | Q4 2024 results highlighting positive RIVER data and CORAL progress. |
| Nov 06 | Q3 2024 earnings | Neutral | -6.5% | Q3 2024 results with advancing trials, higher R&D, and larger net loss. |
Earnings releases have produced modest, mixed reactions, with both aligned and divergent price moves around largely positive clinical and cash runway updates.
Over the past five earnings cycles from Nov 2024 through Nov 2025, Trevi consistently paired financial updates with progress on Haduvio, including Phase 2a RIVER and Phase 2b CORAL data, End‑of‑Phase 2 planning, and cash runway extensions into 2028–2029. Price reactions to these earnings events were small and mixed, with both gains and declines. Today’s full-year 2025 results and chronic cough program timelines extend that narrative of advancing toward Phase 3 while maintaining a sizable cash balance.
Historical Comparison
In the past five earnings reports, TRVI’s average move was -0.36%, with small, mixed reactions despite generally constructive clinical and cash updates.
Earnings updates have tracked Haduvio’s evolution from Phase 2a and Phase 2b data toward Phase 3 planning, while cash balances rose from $65.5M in 2024 to above $190M in 2025, supporting late-stage development.
Market Pulse Summary
This announcement combines full-year 2025 results with clear clinical timelines, including two pivotal Phase 3 IPF-related chronic cough trials and a Phase 2b RCC study, backed by $188.3 million in cash and runway into 2028. Investors may track execution on 2026 trial initiations, future net loss trends from the current $42.8 million level, and whether R&D efficiency continues as programs scale into late-stage development.
Key Terms
idiopathic pulmonary fibrosis medical
interstitial lung disease medical
refractory chronic cough medical
end-of-phase 2 regulatory
phase 3 medical
phase 2b medical
new drug application (nda) regulatory
placebo medical
AI-generated analysis. Not financial advice.
Following the End-of-Phase 2 meeting with the FDA, the Company gained alignment on its Phase 3 program for the treatment of patients with idiopathic pulmonary fibrosis-related chronic cough
On track to initiate a Phase 2b clinical trial for the treatment of patients with refractory chronic cough in the second quarter of 2026
Company ended 2025 with
Management to host a conference call and webcast today at 4:30 p.m. ET
NEW HAVEN, Conn., March 17, 2026 (GLOBE NEWSWIRE) -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC), today announced financial results for the fourth quarter and year ended December 31, 2025, and provided business updates.
"Our progress in 2025 marked a major inflection point for Trevi’s growth trajectory, driven by positive Phase 2 data across our chronic cough programs," said Jennifer Good, President and CEO of Trevi Therapeutics. "These results provide a strong foundation as we pursue our goal of becoming a leader in treating chronic cough. We’ve carried this momentum into 2026 as we gained overall alignment with the FDA during our End-of-Phase 2 meeting for patients with IPF-related chronic cough. We are now focused on initiating the first of our two pivotal Phase 3 IPF-related chronic cough trials, as well as our Phase 2b RCC trial in the second quarter of this year. Looking ahead, Trevi is well positioned to execute on its clinical programs and help address the high unmet need for patients who are burdened by chronic cough in our target indications, where there are no FDA-approved therapies."
Recent Business Highlights
IPF-Related Chronic Cough
- The Company had its End-of-Phase 2 meeting with the FDA and gained overall alignment on the plan for the remaining development program of nalbuphine ER (NAL ER) for the treatment of IPF-related chronic cough. The Company plans to conduct two pivotal Phase 3 clinical trials and obtained agreement on the remaining Phase 1 clinical studies that the Company expects to conduct to support a New Drug Application (NDA) submission. The Company plans to conduct the two Phase 3 trials in parallel and is on track to initiate the first Phase 3 trial in the second quarter of 2026 and the second Phase 3 trial in the second half of 2026.
- The first of the two Phase 3 trials is planned to enroll approximately 300 patients and have 52 weeks of fixed dosing with NAL ER 54 mg twice-a-day (BID), with the primary endpoint at 24 weeks of fixed dosing. The second Phase 3 trial is planned to enroll approximately 130 patients and have 12 weeks of fixed dosing with NAL ER 54 mg BID. The primary efficacy endpoint for both trials will be the relative change from Baseline in 24-hour cough frequency (coughs per hour), as determined by an objective cough monitor, for nalbuphine ER compared with placebo. These trial designs are subject to final review of the protocols by the FDA.
- Key Phase 2b CORAL trial results in patients with IPF-related chronic cough were published in the Journal of the American Medical Association (JAMA) in January 2026.
Refractory Chronic Cough
- The Company plans to initiate a Phase 2b trial of nalbuphine ER for the treatment of patients with RCC in the second quarter of 2026. The Company expects the primary efficacy endpoint of the trial will be the mean change in 24-hour cough frequency, as determined by an objective cough monitor. The trial is subject to final review of the protocol by regulatory authorities.
Non-IPF ILD-Related Chronic Cough
- The Company plans to initiate an adaptive design Phase 2b trial of nalbuphine ER for the treatment of patients with non-IPF ILD-related chronic cough in the second half of 2026, subject to review of the protocol for the trial by the FDA.
Corporate
- The Company plans to host an Investor and Analyst Day on May 7, 2026, from 10:00 a.m. to 12:00 p.m. ET, to discuss the Company's clinical and commercial strategy and will be joined by esteemed KOLs. The in-person event will take place in New York City. To register for the webcast, please visit Trevi’s website or register here.
Fourth Quarter 2025 Financial Highlights
Cash, cash equivalents and marketable securities: The Company ended 2025 with
Research and development (R&D) expenses: R&D expenses for the fourth quarter of 2025 decreased to
General and administrative (G&A) expenses: G&A expenses for the fourth quarter of 2025 increased to
Other Income, net: Other Income, net for the fourth quarter of 2025 increased to
Net loss: For the fourth quarter of 2025, the Company reported a net loss of
Full Year 2025 Financial Highlights
R&D expenses: R&D expenses for the year ended December 31, 2025, were
G&A expenses: G&A expenses for the year ended December 31, 2025, were
Other income, net: Other income, net was
Net loss: For the year ended December 31, 2025, the Company reported a net loss of
Conference Call and Webcast
To register for the live conference call and webcast, please visit the ‘Investors & News’ section of the Company’s website or access directly at ir.trevitherapeutics.com/news-events/events. Please note for phone participants: Once registered, you will receive an email with unique call-in details. An archived replay of the webcast will also be available for 30 days on the Company's website following the event.
About Trevi Therapeutics, Inc.
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine extended-release) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC). Haduvio is the first and only investigational therapy to show a statistically-significant reduction in cough frequency in clinical trials across both patients with IPF chronic cough and in patients with RCC. Haduvio acts on the cough reflex arc both centrally and peripherally as a kappa agonist and a mu antagonist (KAMA), targeting opioid receptors that play a key role in controlling chronic cough. Nalbuphine is not currently scheduled by the U.S. Drug Enforcement Agency.
Chronic cough in patients with IPF and non-IPF ILD is a condition with high unmet need and no FDA-approved therapies. There are ~150,000 U.S. patients with IPF, and two-thirds of these patients are faced with uncontrolled chronic cough. Additionally, there are ~228,000 U.S. patients with non-IPF ILD, with 50
RCC is a condition with high unmet need and no FDA-approved therapies. RCC is defined as a persistent cough lasting >8 weeks despite treatment for an underlying condition (i.e., asthma, gastroesophageal reflux disease, non-asthmatic eosinophilic bronchitis, upper airway cough syndrome, or post-nasal drip) and includes unexplained chronic cough. There are ~2-3 million U.S. patients with RCC, and it is believed to be associated with cough reflex hypersensitivity involving both the central and peripheral nervous systems. RCC is highly debilitating and may impact patients physically, psychologically, and socially.
Trevi intends to propose Haduvio as the trade name for oral nalbuphine ER. Its safety and efficacy have not been evaluated by any regulatory authority.
For more information, visit www.TreviTherapeutics.com and follow Trevi on X (formerly Twitter) and LinkedIn.
Forward-Looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding Trevi's business plans and objectives, including future plans or expectations for Haduvio and plans and timing with respect to clinical trials and clinical data, as well as regulatory submissions, statements regarding FDA guidance, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost and timing of Trevi’s product candidate development activities and clinical trials; the risk that positive data from a clinical trial may not necessarily be predictive of the results of later clinical trials in the same or a different indication; uncertainties regarding Trevi's ability to execute on its strategy; uncertainties with respect to regulatory authorities' views as to the data from Trevi's clinical trials and next steps in the development path for Haduvio in the United States and foreign countries; uncertainties inherent in estimating Trevi's cash runway, future expenses and other financial results, including Trevi's ability to fund future operations, including clinical trials, as well as other risks and uncertainties set forth in the quarterly report on Form 10-Q for the quarter ended September 30, 2025 filed with the Securities and Exchange Commission and in subsequent filings made by the Company with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
| Trevi Therapeutics, Inc. Selected Balance Sheet Data (unaudited) (amounts in thousands) | |||||||
| December 31, 2025 | December 31, 2024 | ||||||
| Cash and cash equivalents | $ | 18,914 | $ | 34,097 | |||
| Marketable securities | 169,346 | 73,525 | |||||
| Working capital | 181,907 | 98,919 | |||||
| Total assets | 193,439 | 110,900 | |||||
| Stockholders' equity | 183,244 | 99,644 | |||||
| Trevi Therapeutics, Inc. Selected Statement of Operations Data (unaudited) (amounts in thousands, except per share amounts) | |||||||||||||||
| Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||
| 2025 | 2024 | 2025 | 2024 | ||||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | $ | 6,194 | $ | 9,327 | $ | 33,478 | $ | 39,377 | |||||||
| General and administrative | 4,026 | 2,916 | 15,850 | 12,147 | |||||||||||
| Total operating expenses | 10,220 | 12,243 | 49,328 | 51,524 | |||||||||||
| Loss from operations | (10,220 | ) | (12,243 | ) | (49,328 | ) | (51,524 | ) | |||||||
| Other income, net | 1,888 | 844 | 6,505 | 3,583 | |||||||||||
| Loss before income taxes | (8,332 | ) | (11,399 | ) | (42,823 | ) | (47,941 | ) | |||||||
| Income tax (benefit) provision | (16 | ) | 17 | (64 | ) | (30 | ) | ||||||||
| Net loss | $ | (8,316 | ) | $ | (11,416 | ) | $ | (42,759 | ) | $ | (47,911 | ) | |||
| Basic and diluted net loss per common share outstanding | $ | (0.06 | ) | $ | (0.11 | ) | $ | (0.32 | ) | $ | (0.47 | ) | |||
| Weighted average common shares used in net loss per share attributable to common stockholders, basic and diluted | 145,502,344 | 106,009,686 | 134,747,198 | 101,971,873 | |||||||||||
Investor Contact
Jonathan Carlson
Trevi Therapeutics, Inc.
(203) 654 3286
IR@trevitx.com
Media Contact
Rosalia Scampoli
914-815-1465
rscampoli@marketcompr.com
FAQ
What did Trevi Therapeutics (TRVI) announce about FDA alignment on March 17, 2026?
When will Trevi initiate Phase 3 trials for IPF-related chronic cough (TRVI)?
How much cash did Trevi Therapeutics (TRVI) report at year-end 2025 and runway expectations?
What are the design details of Trevi’s planned Phase 3 IPF-related chronic cough trials (TRVI)?
What clinical programs will Trevi (TRVI) start in 2026 besides IPF Phase 3 trials?
