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Trevi Therapeutics Inc (TRVI)
NASDAQ:TRVI
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Trevi Therapeutics
(NASDAQ:TRVI)
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Rating:56Neutral
Price Target:
$11.50
▼(-14.63% Downside)
Action:ReiteratedDate:03/18/26
The score is held back primarily by weak financial performance (no revenue, widening losses, and increasing cash burn) and a mixed technical backdrop. These are partially offset by a strong earnings-call read-through highlighting FDA alignment, defined Phase III execution plans, and cash runway into 2028; valuation support is limited due to non-meaningful P/E and no dividend yield provided.
Positive Factors
Regulatory alignment: End-of-Phase 2 meeting
Clear FDA alignment on endpoints and a pathway to an NDA materially reduces regulatory execution uncertainty. This structural de-risking enables definitive Phase III designs, more predictable development timelines and focused resource allocation, improving approval probability over the coming 2–6 months.
Cash runway into 2028
A multi-year cash runway directly supports planned registrational and dose‑finding programs without immediate financing. That funding buffer preserves operational continuity, reduces near-term dilution risk and allows management to execute trial enrollment and regulatory interactions through key readouts over the next 2–6 months.
Low leverage and expanding equity/assets
Very low debt and stronger equity/assets provide financial flexibility to fund development programs and respond to trial or regulatory contingencies. Reduced leverage lowers bankruptcy/default risk and supports strategic options (partnerships, phasing trials) over a multi-quarter horizon.
Negative Factors
No product revenue; persistent net losses
Absent product sales, Trevi must fund operations via capital markets or partnerships. Persistent net losses mean continued dependency on external financing, which increases dilution risk and constraints on strategic choices if market conditions or trial outcomes change within the next several quarters.
Accelerating cash burn and negative free cash flow
Rising operating and free cash outflows erode runway and may force financing ahead of planned milestones. Accelerating burn heightens the probability of dilution or scaled-back programs if trials require more patients or time, posing material financing risk across the 2–6 month horizon.
52-week controlled safety requirement prolongs development
A mandatory 52‑week controlled safety database structurally delays efficacy readouts and extends exposure to competitive or regulatory shifts. This increases timeline and funding uncertainty, potentially necessitating additional capital or trial adjustments and complicating label/timing plans over the next several quarters.
Trevi Therapeutics (TRVI) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$1.37B
Dividend YieldN/A
Average Volume (3M)2.56M
Price to Earnings (P/E)―
Beta (1Y)0.47
Revenue GrowthN/A
EPS Growth15.84%
CountryUS
Employees31
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.06
Shares Outstanding128,230,130
10 Day Avg. Volume1,820,513
30 Day Avg. Volume2,561,308
Financial Highlights & Ratios
PEG Ratio1.11
Price to Book (P/B)9.91
Price to Sales (P/S)0.00
P/FCF Ratio-43.15
Enterprise Value/Market Cap0.99
Enterprise Value/RevenueN/A
Enterprise Value/Gross Profit-35.60K
Enterprise Value/Ebitda-29.57
Forecast
1Y Price Target
$21.83Price Target Upside62.09% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering6
EPS Forecast (FY)-0.49
Revenue Forecast (FY)N/A
Trevi Therapeutics Business Overview & Revenue Model
Company DescriptionTrevi Therapeutics, Inc., a clinical-stage biopharmaceutical company, focuses on the development and commercialization of Haduvio to treat serious neurologically mediated conditions. The company is developing Haduvio, an oral extended-release formulation of nalbuphine, which is in phase IIb/III clinical trial for the treatment of chronic pruritus, chronic cough in patients with idiopathic pulmonary fibrosis. It has a license agreement with Endo Pharmaceuticals Inc. to develop and commercialize products incorporating nalbuphine hydrochloride in any formulation. The company was incorporated in 2011 and is headquartered in New Haven, Connecticut.
How the Company Makes MoneyAs a clinical-stage biopharmaceutical company, Trevi Therapeutics has historically not generated significant recurring revenue from product sales because its lead program remains under clinical development and is not broadly commercialized. Publicly available materials indicate the company primarily funds operations through financing activities (e.g., issuing equity and related capital-raising transactions). Details on material recurring revenue streams from product sales, ongoing commercial royalties, or large, sustained collaboration/licensing payments are not available; therefore, information on significant revenue-generating partnerships, product revenues, or royalty streams is null.
Trevi Therapeutics Earnings Call Summary
Earnings Call Date:Mar 17, 2026
(Q4-2025)
| % Change Since: |
Next Earnings Date:May 07, 2026
Earnings Call Sentiment Positive
Overall the call conveyed notable progress: a positive End-of-Phase 2 meeting with the FDA, clear Phase III plans and timelines, strong clinical momentum from 2025 data, and a solid cash runway into 2028 to reach key readouts. Key risks include the FDA requirement for a 52-week controlled safety database that delays the 24-week efficacy readout, potential additional DDI requirements if new therapies are approved, uncertainty around orphan designation, and the extended timelines associated with global Phase III execution. On balance, achievements and forward execution plans outweigh the manageable challenges.Q4-2025 Updates
Positive Updates
Positive End-of-Phase 2 Meeting with FDA
Management reported a collaborative End-of-Phase 2 meeting with the FDA for the IPF-related chronic cough program with alignment on pathway to NDA, primary endpoint (objective cough monitor), and agreement to proceed with 2 pivotal Phase III trials.
Planned Phase III Program and Timelines
Company plans two parallel global Phase III trials for IPF-related chronic cough: a 52-week trial (primary efficacy at 24 weeks, ~300 patients) and a confirmatory 12-week trial (~130 patients) with initiation of the first trial expected in Q2 and the second in H2 of the year.
Strong 2025 Clinical Data Momentum
Positive 2025 readouts from CORAL (IPF chronic cough) and RIVER (refractory chronic cough) trials supported capital raises and enabled progression to registrational programs.
Cash Runway to Fund Key Milestones
Trevi ended 2025 with approximately $188 million in cash, cash equivalents and marketable securities, providing an expected runway into 2028 to reach top-line data for: Phase IIb RCC, Phase IIb non-IPF chronic cough and the 12-week pivotal Phase III IPF readout.
Market Opportunity and Addressable Patient Populations
Estimated U.S. IPF population of ~150,000 with ~2/3 (≈66.7%) having uncontrolled chronic cough; non-IPF ILD estimated at ~228,000 with 50%–60% (≈114k–136.8k) having uncontrolled cough — more than doubling the market opportunity beyond IPF alone.
RCC and Dose Optimization Strategy
Planned Phase IIb parallel-arm dose-ranging RCC trial (3 doses + placebo) to determine dosing; crossover data suggest activity at low dose and interest in exploring lower or once-daily dosing and related IP/formulation strategies.
Operational Readiness and Enrollment Expectations
Management expects enrollment for the larger Phase III to take ~1 year with ~80–100 sites (majority U.S.); strong physician and site interest reported and plans for patient advocacy engagement to support recruitment.
Secondary Endpoints and Patient-Reported Outcomes
Primary objective cough monitor retained; key secondary PROs (cough frequency/severity) and breathlessness moved into key secondary category after encouraging CORAL findings, strengthening potential label-relevant data.
Regulatory and Safety Preparations
Agreement with FDA on remaining standard label-enabling Phase I studies (renal/hepatic impairment, food effect) and DDI assessments (including interaction with new antifibrotic nerandomilast and CYP inducer/inhibitor studies) to support NDA.
Controlled-Substance/Scheduling Outlook
Management reported constructive discussions with controlled-substances staff, submitted human abuse potential and respiratory safety data, and expressed growing conviction the product will remain unscheduled.
Negative Updates
52-Week Controlled Safety Requirement Delays 24-Week Readout
FDA expectation for 52 weeks of controlled safety requires placebo to remain blinded for the full 52 weeks, preventing an early unblinded 24-week readout and delaying availability of the 24-week efficacy data.
Cash Runway Does Not Cover 24-Week Readout
While $188M runway covers top-line data for the 12-week pivotal Phase III readout, management acknowledged this funding does not cover the delayed 24-week IPF readout driven by the 52-week safety requirement.
Potential Need for Additional DDI Studies
If new IPF therapies (e.g., recently emerging drugs) are approved during development, Trevi may need additional Phase I drug-drug interaction studies to support labeling or safety, introducing timing and resource risk.
Uncertainty on Orphan Designation
Company plans to file for orphan drug designation for IPF-related chronic cough but management warned the designation may be challenged because success in IPF cough could imply broader utility, so outcome is uncertain.
Regulatory and Timeline Risk from Long Follow-Up
The 52-week safety requirement and global trial timelines (enrollment ~1 year + 52 weeks follow-up) create extended development timelines and potential exposure to regulatory or competitive changes during that period.
Readiness for RCC Full Readout Timeline
RCC Phase IIb will not be fully read out this year; company expects a sample-size reestimation readout once 50% of patients complete the trial, meaning full data will lag and could delay potential RCC label decisions.
Placebo Response Considerations
CORAL placebo response was ~17% (objective cough); variability in placebo response remains an uncertainty for larger Phase III trials despite powering >90% for primary and key secondary endpoints.
Company Guidance
Trevi said the FDA End-of-Phase 2 meeting was positive and provided a clear path to NDA, and management guided to initiate a global Phase III program in IPF-related chronic cough with Trial 1 starting in Q2 (52 weeks total, primary efficacy at 24 weeks, ~300 patients, powered >90% for primary and key secondaries and to provide a 52‑week controlled safety database) and a confirmatory Phase III to start in H2 (primary efficacy at 12 weeks, ~130 patients); they also plan a Type C meeting in Q3 to propose an adaptive Phase IIb → single pivotal Phase III program for non‑IPF ILD (initiating by year‑end if accepted), estimate ~228,000 non‑IPF ILD patients with 50–60% uncontrolled cough, and will run a parallel‑arm Phase IIb RCC dose‑ranging trial (3 doses + placebo) starting in Q2 with a sample‑size reestimation when 50% of patients complete; remaining label‑enabling Phase I studies (DDI with nerandomilast, CYP inducer/inhibitor, renal/hepatic impairment, food effect) can run in parallel, an orphan drug application will be filed this year, and the company ended 2025 with ~$188M cash giving runway into 2028 sufficient to deliver top‑line data from the Phase IIb RCC, Phase IIb non‑IPF, and the 12‑week pivotal Phase III IPF readout.Trevi Therapeutics Financial Statement Overview
Summary
Development-stage profile with no revenue, persistent and recently widening net losses, and accelerating negative operating/free cash flow. The balance sheet is a relative strength with very low debt and expanding equity/assets, but rising burn increases future funding/dilution risk.Income Statement
The company reports no revenue across the annual periods provided, consistent with a pre-commercial biotech profile. Losses are persistent: net income remains deeply negative each year, with a notable step-up in losses in 2024 and again in 2025 versus 2022–2023, indicating higher spend without offsetting revenue. A modest positive is that losses were smaller in 2022–2023 than 2020–2021, but the more recent deterioration outweighs that improvement.18
Very Negative
Balance Sheet
Leverage is very low in recent years, with total debt under ~$1.1M in 2024–2025 and debt-to-equity near zero in 2023–2024, which reduces financial risk. Equity and assets expanded meaningfully from 2023 to 2025, supporting operational runway. The key weakness is profitability-driven balance sheet pressure: returns on equity are strongly negative (loss-making), and while equity improved sharply since 2021, it is still exposed to ongoing cash burn and potential future dilution needs.64
Positive
Cash Flow
Cash generation is consistently negative: operating cash flow and free cash flow are materially negative every year shown, reflecting continued funding needs. Cash burn worsened in 2024 and again in 2025 versus 2023, and free cash flow growth is negative in the latest periods, signaling accelerating outflows. A relative positive is that free cash flow broadly tracks net losses (cash burn aligns with reported losses rather than being meaningfully worse), but the direction of burn is unfavorable.22
Negative
| Breakdown | TTM | Dec 2025 | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|---|
Income Statement | ||||||
| Total Revenue | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| Gross Profit | -38.00K | -132.00K | -147.00K | 0.00 | 0.00 | -50.00K |
| EBITDA | -45.74M | -49.33M | -47.79M | -28.58M | -27.98M | -32.71M |
| Net Income | -45.86M | -42.76M | -47.91M | -29.07M | -29.15M | -33.94M |
Balance Sheet | ||||||
| Total Assets | 199.36M | 193.44M | 110.90M | 89.40M | 123.02M | 38.48M |
| Cash, Cash Equivalents and Short-Term Investments | 194.93M | 188.26M | 107.62M | 82.97M | 120.51M | 36.83M |
| Total Debt | 823.00K | 753.00K | 1.03M | 1.34M | 9.18M | 14.63M |
| Total Liabilities | 9.57M | 10.20M | 11.26M | 6.86M | 15.56M | 21.40M |
| Stockholders Equity | 189.79M | 183.24M | 99.64M | 82.55M | 107.46M | 17.07M |
Cash Flow | ||||||
| Free Cash Flow | -44.03M | -42.10M | -38.29M | -31.85M | -28.33M | -28.95M |
| Operating Cash Flow | -44.01M | -42.09M | -38.26M | -31.71M | -28.18M | -28.95M |
| Investing Cash Flow | -87.37M | -94.11M | -21.53M | 59.43M | -107.37M | 0.00 |
| Financing Cash Flow | 172.20M | 121.01M | 61.48M | -7.91M | 111.31M | 20.77M |
Trevi Therapeutics Technical Analysis
Negative
13.47
Price Trends
11.20
Negative
11.61
Negative
9.60
Positive
Market Momentum
0.05
Positive
46.09
Neutral
11.83
Positive
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For TRVI, the sentiment is Negative. The current price of 13.47 is above the 20-day moving average (MA) of 11.63, above the 50-day MA of 11.20, and above the 200-day MA of 9.60, indicating a neutral trend. The MACD of 0.05 indicates Positive momentum. The RSI at 46.09 is Neutral, neither overbought nor oversold. The STOCH value of 11.83 is Positive, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Negative sentiment for TRVI.
Trevi Therapeutics Risk Analysis
Trevi Therapeutics disclosed 74 risk factors in its most recent earnings report. Trevi Therapeutics reported the most risks in the "Tech & Innovation" category.
Finance & Corporate - Financial and accounting risks. Risks related to the execution of corporate activity and strategy
Latest Risks Added 0 New Risks
Trevi Therapeutics Peers Comparison
UnderperformOutperform
Sector (51)
Name | Overall Rating | Market Cap | P/E Ratio | ROE | Dividend Yield | Revenue Growth | EPS Growth |
|---|---|---|---|---|---|---|---|
67 Neutral | $8.04B | -21.87 | -58.74% | ― | 364.98% | -25.33% | |
57 Neutral | $2.10B | -5.95 | -399.10% | ― | -32.79% | 36.87% | |
57 Neutral | $1.09B | -5.55 | -38.79% | ― | ― | 4.29% | |
56 Neutral | $1.37B | -42.49 | -31.23% | ― | ― | 15.84% | |
56 Neutral | $2.35B | ― | -84.99% | ― | 103.75% | 33.84% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
50 Neutral | $1.49B | -14.96 | -57.48% | ― | 1137.19% | 70.51% |
* Healthcare Sector Average
TRVI
Trevi Therapeutics
10.69
3.88
56.98%
NKTR
Nektar Therapeutics
73.18
59.72
443.77%
WVE
Wave Life Sciences
11.90
1.86
18.53%
ORIC
Oric Pharmaceuticals
10.86
3.39
45.38%
NUVB
Nuvation Bio
4.28
2.30
116.16%
PRAX
Praxis Precision Medicines
288.79
250.17
647.77%
Trevi Therapeutics Corporate Events
Business Operations and StrategyRegulatory Filings and Compliance
Trevi Therapeutics Aligns With FDA on Phase 3 Cough Trials
Positive
Mar 9, 2026
On March 9, 2026, Trevi Therapeutics reported that an End-of-Phase 2 meeting with the U.S. Food and Drug Administration resulted in overall alignment on its remaining development program for IPF-related chronic cough. The company obtained FDA agreement on the design of its planned Phase 3 program and the remaining Phase 1 work needed to support a future regulatory filing.
Trevi plans to run two global, randomized, double-blind, placebo-controlled Phase 3 trials of nalbuphine ER 54 mg twice daily, with the first starting in the second quarter of 2026 and the second in the second half of 2026. The larger study will enroll about 300 patients over 52 weeks with a 24-week primary endpoint, while the smaller will enroll about 130 patients over 12 weeks, and both will measure relative change in 24-hour cough frequency versus placebo, with final trial designs still subject to FDA protocol review.
The most recent analyst rating on (TRVI) stock is a Buy with a $22.00 price target. To see the full list of analyst forecasts on Trevi Therapeutics stock, see the TRVI Stock Forecast page.
Glossary
BuyA stock rated as a "Buy" is expected to perform better than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock is likely to deliver higher returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
HoldA stock rated as a "Hold" is expected to perform in line with the overall market or a specific benchmark. This rating indicates that the stock is neither particularly compelling nor unfavorable for investment. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
SellA stock rated as a "Sell" is expected to perform worse than the overall market or a specific benchmark over the near-to-medium term. This rating suggests the stock may deliver lower returns compared to other stocks in the same sector or market index. Note: This is not investment advice; please consult a financial advisor before making investment decisions.
Disclaimer
This AI Analyst Stock Report is automatically generated by our AI systems using advanced algorithms and publicly available financial, technical, and market data. While the information provided aims to be accurate and insightful, it is intended for informational purposes only and should not be considered financial advice. Any content created by an AI (Artificial Intelligence) system may contain inaccuracies and/or contain errors. Investing in stocks carries inherent risks, and past performance is not indicative of future results. This report does not account for your personal financial circumstances, objectives, or risk tolerance. Always conduct your own research or consult with a qualified financial advisor before making investment decisions. The analysis and recommendations provided are based on historical and current data and may not fully reflect future market conditions or unexpected developments. Neither the creators of this report nor its affiliated entities guarantee the accuracy, completeness, or reliability of the information presented. Use this report at your own discretion and risk.