Trevi Therapeutics Inc (TRVI)
NASDAQ:TRVI
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Trevi Therapeutics
(NASDAQ:TRVI)
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Rating:59Neutral
Price Target:
$14.50
▲(7.65% Upside)
Action:ReiteratedDate:04/16/26
The score is held back primarily by weak financial performance (no revenue, widening losses, and worsening cash burn) despite a low-debt balance sheet. Technicals are supportive with an established uptrend, but overbought signals temper near-term risk/reward. The latest earnings call was constructive on FDA alignment and Phase III plans with solid cash resources for key milestones, while valuation remains constrained by ongoing losses and no dividend support.
Positive Factors
Regulatory alignment with FDA
Clear FDA alignment reduces regulatory uncertainty and creates a defined path to registrational trials and an NDA. This durable de‑risking improves planning, trial design certainty and investor visibility across the multi-year development program.
Negative Factors
No revenue and persistent losses
As a pre-commercial biotech with no product revenue, ongoing R&D and SG&A drive sustained net losses. Without product cash inflows, the company remains dependent on capital markets or partnerships to fund continued development and commercialization.
Read all positive and negative factors
Positive Factors
Negative Factors
Regulatory alignment with FDA
Clear FDA alignment reduces regulatory uncertainty and creates a defined path to registrational trials and an NDA. This durable de‑risking improves planning, trial design certainty and investor visibility across the multi-year development program.
Read all positive factors
Trevi Therapeutics (TRVI) vs. SPDR S&P 500 ETF (SPY)
Market Cap
$1.83B
Dividend YieldN/A
Average Volume (3M)2.56M
Price to Earnings (P/E)―
Beta (1Y)0.45
Revenue GrowthN/A
EPS Growth15.84%
CountryUS
Employees31
SectorHealthcare
Sector Strength45
IndustryBiotechnology
Share Statistics
EPS (TTM)-0.06
Shares Outstanding128,397,280
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-58.52K
Enterprise Value/Ebitda-40.71
Forecast
1Y Price Target
$22.00Price Target Upside63.33% Upside
Rating ConsensusStrong Buy
Number of Analyst Covering7
EPS Forecast (FY)-0.45
Revenue Forecast (FY)N/A
Trevi Therapeutics Business Overview & Revenue Model
Company Description
Trevi 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 form...
How the Company Makes Money
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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.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.
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.
Read all updates
Q4-2025 Updates
Positive
Negative
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.
Read all positive updates
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
Income Statement
18
Very Negative
Balance Sheet
64
Positive
Cash Flow
22
Negative
| Breakdown | Dec 2025 | Dec 2024 | Dec 2023 | Dec 2022 | Dec 2021 |
|---|---|---|---|---|---|
Income Statement | |||||
| Total Revenue | 0.00 | 0.00 | 0.00 | 0.00 | 0.00 |
| Gross Profit | -132.00K | -147.00K | 0.00 | 0.00 | -50.00K |
| EBITDA | -49.33M | -47.79M | -28.58M | -27.98M | -32.71M |
| Net Income | -42.76M | -47.91M | -29.07M | -29.15M | -33.94M |
Balance Sheet | |||||
| Total Assets | 193.44M | 110.90M | 89.40M | 123.02M | 38.48M |
| Cash, Cash Equivalents and Short-Term Investments | 188.26M | 107.62M | 82.97M | 120.51M | 36.83M |
| Total Debt | 753.00K | 1.03M | 1.34M | 9.18M | 14.63M |
| Total Liabilities | 10.20M | 11.26M | 6.86M | 15.56M | 21.40M |
| Stockholders Equity | 183.24M | 99.64M | 82.55M | 107.46M | 17.07M |
Cash Flow | |||||
| Free Cash Flow | -42.10M | -38.29M | -31.85M | -28.33M | -28.95M |
| Operating Cash Flow | -42.09M | -38.26M | -31.71M | -28.18M | -28.95M |
| Investing Cash Flow | -94.11M | -21.53M | 59.43M | -107.37M | 0.00 |
| Financing Cash Flow | 121.01M | 61.48M | -7.91M | 111.31M | 20.77M |
Trevi Therapeutics Technical Analysis
Positive
13.47
Price Trends
11.69
Positive
11.80
Positive
10.19
Positive
Market Momentum
0.65
Negative
72.13
Negative
94.90
Negative
Evaluating momentum and price trends is crucial in stock analysis to make informed investment decisions. For TRVI, the sentiment is Positive. The current price of 13.47 is above the 20-day moving average (MA) of 12.09, above the 50-day MA of 11.69, and above the 200-day MA of 10.19, indicating a bullish trend. The MACD of 0.65 indicates Negative momentum. The RSI at 72.13 is Negative, neither overbought nor oversold. The STOCH value of 94.90 is Negative, not indicating any strong overbought or oversold conditions. Overall, these indicators collectively point to a Positive 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 |
|---|---|---|---|---|---|---|---|
60 Neutral | $9.47B | -21.87 | -58.74% | ― | 364.98% | -25.33% | |
59 Neutral | $1.83B | -42.49 | -25.49% | ― | ― | 15.84% | |
57 Neutral | $2.39B | -5.95 | -399.10% | ― | -32.79% | 36.87% | |
52 Neutral | $1.03B | -5.55 | -38.79% | ― | ― | 4.29% | |
51 Neutral | $7.86B | -0.30 | -43.30% | 2.27% | 22.53% | -2.21% | |
50 Neutral | $1.68B | -14.96 | -57.48% | ― | 1137.19% | 70.51% | |
49 Neutral | $1.43B | -14.03 | -84.99% | ― | 103.75% | 33.84% |
* Healthcare Sector Average
TRVI
Trevi Therapeutics
14.27
8.20
135.09%
NKTR
Nektar Therapeutics
83.22
73.67
771.78%
WVE
Wave Life Sciences
7.59
1.67
28.21%
ORIC
Oric Pharmaceuticals
10.28
5.51
115.51%
NUVB
Nuvation Bio
4.82
2.85
144.67%
PRAX
Praxis Precision Medicines
339.93
306.14
906.01%
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 agre...
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.