Trevi Therapeutics Aims for Multiple Phase III Trial Launches for Chronic Cough Indications in 2026 as Regulatory Efforts Speed Up
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Nov 13 2025
0mins
Should l Buy TRVI?
Source: SeekingAlpha
Management Insights: Trevi Therapeutics reported positive data from the CORAL and RIVER trials, enabling a $115 million capital raise and a cash runway into 2028. The company is preparing for regulatory engagement with the FDA regarding Phase III programs for chronic cough in patients with idiopathic pulmonary fibrosis (IPF).
Financial Performance: For Q3 2025, Trevi reported a net loss of $11.8 million, an improvement from $13.2 million in Q3 2024, with R&D expenses decreasing to $10.1 million. Cash and investments totaled approximately $195 million as of September 30, 2025.
Clinical Trial Plans: The company plans to initiate multiple clinical trials in 2026, including Phase III trials for IPF cough and a Phase IIb trial for refractory chronic cough (RCC). Management emphasized the importance of aligning with the FDA on study designs and protocols.
Analyst Sentiment: Analysts expressed a neutral to slightly positive tone during the earnings call, focusing on regulatory clarity and trial design. Management maintained a confident outlook, highlighting their readiness to execute on upcoming milestones and the potential for significant shareholder value creation.
Trade with 70% Backtested Accuracy
Stop guessing "Should I Buy TRVI?" and start using high-conviction signals backed by rigorous historical data.
Sign up today to access powerful investing tools and make smarter, data-driven decisions.
Analyst Views on TRVI
Wall Street analysts forecast TRVI stock price to rise
9 Analyst Rating
9 Buy
0 Hold
0 Sell
Strong Buy
Current: 10.940
Low
16.00
Averages
21.22
High
25.00
Current: 10.940
Low
16.00
Averages
21.22
High
25.00
About TRVI
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on the development and commercialization of the investigational therapy Haduvio (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF), chronic cough in patients with non-IPF interstitial lung disease, and refractory chronic cough. Haduvio is an oral extended-release (ER) formulation of nalbuphine. Nalbuphine is a mixed kappa-opioid receptor agonist and mu-opioid receptor antagonist. It has conducted a Phase II clinical trial and an open-label extension study of Haduvio in pruritus in patients with prurigo nodularis and a Phase IIb/III clinical trial. The Company’s Haduvio development programs include Chronic Cough in IPF Program, RCC Program, and Prurigo Nodularis Program. The Company’s subsidiary is Trevi Therapeutics Limited.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Trevi Therapeutics Reports Positive Phase 2b Results for Nalbuphine ER, Over 60% Cough Frequency Reduction at Week 6
- Clinical Trial Results: Trevi Therapeutics announced in JAMA that the Phase 2b CORAL trial demonstrated a statistically significant reduction in 24-hour cough frequency at Week 6, with over 60% of patients achieving at least a 50% reduction, indicating nalbuphine ER's potential for treating chronic cough in IPF patients.
- Patient-Reported Consistency: The consistency between patient-reported cough frequency and objective monitoring results highlights that patients not only experienced fewer coughs but also reported overall improvements, underscoring the significant burden chronic cough imposes on IPF patients' quality of life.
- Safety Results: The safety profile of the CORAL trial was consistent with previous nalbuphine ER studies, with discontinuation rates due to adverse events at 5.6% for nalbuphine ER and 5.0% for placebo, indicating a favorable safety profile for the drug.
- Market Demand: With approximately 150,000 IPF patients in the U.S., two-thirds of whom suffer from uncontrolled chronic cough, there is a pressing need for effective treatment options, and the development of nalbuphine ER could address this unmet medical need.
See More
Trevi Therapeutics Reports Significant Cough Frequency Reduction with Nalbuphine ER in Phase 2b Trial
- Clinical Trial Results: Trevi Therapeutics published Phase 2b CORAL trial results in JAMA, showing statistically significant reductions in 24-hour objective cough frequency across all nalbuphine ER dose groups at Week 6, indicating the drug's potential for treating chronic cough in patients with idiopathic pulmonary fibrosis (IPF).
- Patient Response Consistency: Over 60% of patients treated with nalbuphine ER achieved at least a 50% reduction in 24-hour cough frequency by Week 6, with patient-reported outcomes aligning with objective monitoring results, underscoring the drug's clinical value and overall patient improvement.
- Safety Analysis: The safety profile from the CORAL trial was consistent with previous studies, showing a 5.6% discontinuation rate due to adverse events in the nalbuphine ER group, comparable to 5.0% in the placebo group, indicating good safety for further development.
- Market Demand: With approximately 150,000 patients suffering from IPF in the U.S., two-thirds of whom experience uncontrolled chronic cough, the development of nalbuphine ER addresses this significant unmet medical need and has the potential to enhance patient quality of life while reducing morbidity and mortality risks.
See More
Trevi Therapeutics Schedules Phase 2 Trials for Chronic Cough in 2026
- FDA Meeting Scheduled: Trevi Therapeutics plans to hold an End-of-Phase 2 meeting with the FDA in Q1 2026 to align on its chronic cough treatment program, which aims to advance the clinical development of Haduvio.
- Clinical Trial Initiation: The company expects to initiate a Phase 2b trial for refractory chronic cough in the first half of 2026, providing new treatment options for patients with high unmet needs in this area.
- Market Demand Analysis: In the U.S., approximately 150,000 patients with idiopathic pulmonary fibrosis face uncontrolled chronic cough, indicating significant market potential and urgency for this treatment, which could greatly enhance patient quality of life.
- Strategic Execution Plan: The CEO of Trevi stated that 2026 will be a pivotal year focused on advancing Haduvio's clinical development, aiming to provide effective treatment solutions for chronic cough patients and further solidify its position in the biopharmaceutical sector.
See More
Harvest Announces 2025 ETF Reinvested Distributions
- Annual Reinvested Distributions: Harvest Portfolios Group has announced the final annual reinvested distributions for its ETFs for the 2025 tax year, with all distributions being non-cash, ensuring that the number of units held and the net asset value of the ETFs remain unchanged, thereby maintaining asset stability for investors.
- Tax Implications Explained: The distributions will be reported as taxable, which will increase each unitholder's adjusted cost base, impacting future tax handling and ensuring investors are aware of their tax responsibilities.
- Distribution Details Update: All final reinvested capital gain and income distributions for Harvest ETFs are reported as zero, reflecting the company's cautious strategy in the current market environment aimed at protecting investor interests.
- Enhanced Information Transparency: Harvest commits to reporting the actual taxable amounts and nature of distributions to brokers through CDS in early 2026, enhancing transparency and aiding investors in making informed decisions.
See More
Harvest Announces Final Annual Reinvested Distributions for 2025 Tax Year
- Reinvestment Distribution Announcement: Harvest Portfolios Group Inc. announces the final annual reinvested distributions for its ETFs for the 2025 tax year, with all distributions being non-cash, ensuring that the number of units held and the net asset value of the ETFs remain unchanged.
- Tax Implications Explained: The distributions will be reported as taxable, expected to be communicated to brokers through CDS in early 2026, which will increase each unitholder's adjusted cost base and impact future tax considerations.
- Distribution Details Update: All Harvest ETFs report zero reinvested capital gain and income distributions, indicating no distributable earnings for the year, which may affect investor return expectations.
- Record Date Set: December 31, 2025, is established as the ex-dividend date for all unitholders of record, ensuring investors are informed of distribution details to make timely investment decisions.
See More
Harvest ETFs Updates 2025 Estimated Reinvested Distributions
- Distribution Amount Revision: Harvest has announced a revision of the estimated reinvested distributions for 2025, which will be reported to brokers through CDS in early 2026, ensuring investors are informed about tax implications.
- Non-Cash Distribution Mechanism: The annual distributions for all Harvest ETFs will be reinvested in a non-cash format, ensuring that the number of units held and the net asset value remain unchanged, thereby maintaining asset stability for investors.
- Tax Implications Explained: The reinvested distributions will be treated as taxable distributions, increasing each unitholder's adjusted cost base, which will impact future tax planning.
- Final Distribution Announcement: Harvest expects to announce the final year-end reinvested distribution amounts around December 31, 2025, ensuring investors receive timely access to critical information.
See More
Trevi Therapeutics Reports Positive Phase 2b Results for Nalbuphine ER, Over 60% Cough Frequency Reduction at Week 6
- Clinical Trial Results: Trevi Therapeutics announced in JAMA that the Phase 2b CORAL trial demonstrated a statistically significant reduction in 24-hour cough frequency at Week 6, with over 60% of patients achieving at least a 50% reduction, indicating nalbuphine ER's potential for treating chronic cough in IPF patients.
- Patient-Reported Consistency: The consistency between patient-reported cough frequency and objective monitoring results highlights that patients not only experienced fewer coughs but also reported overall improvements, underscoring the significant burden chronic cough imposes on IPF patients' quality of life.
- Safety Results: The safety profile of the CORAL trial was consistent with previous nalbuphine ER studies, with discontinuation rates due to adverse events at 5.6% for nalbuphine ER and 5.0% for placebo, indicating a favorable safety profile for the drug.
- Market Demand: With approximately 150,000 IPF patients in the U.S., two-thirds of whom suffer from uncontrolled chronic cough, there is a pressing need for effective treatment options, and the development of nalbuphine ER could address this unmet medical need.
See More
Trevi Therapeutics Reports Significant Cough Frequency Reduction with Nalbuphine ER in Phase 2b Trial
- Clinical Trial Results: Trevi Therapeutics published Phase 2b CORAL trial results in JAMA, showing statistically significant reductions in 24-hour objective cough frequency across all nalbuphine ER dose groups at Week 6, indicating the drug's potential for treating chronic cough in patients with idiopathic pulmonary fibrosis (IPF).
- Patient Response Consistency: Over 60% of patients treated with nalbuphine ER achieved at least a 50% reduction in 24-hour cough frequency by Week 6, with patient-reported outcomes aligning with objective monitoring results, underscoring the drug's clinical value and overall patient improvement.
- Safety Analysis: The safety profile from the CORAL trial was consistent with previous studies, showing a 5.6% discontinuation rate due to adverse events in the nalbuphine ER group, comparable to 5.0% in the placebo group, indicating good safety for further development.
- Market Demand: With approximately 150,000 patients suffering from IPF in the U.S., two-thirds of whom experience uncontrolled chronic cough, the development of nalbuphine ER addresses this significant unmet medical need and has the potential to enhance patient quality of life while reducing morbidity and mortality risks.
See More
Trevi Therapeutics Schedules Phase 2 Trials for Chronic Cough in 2026
- FDA Meeting Scheduled: Trevi Therapeutics plans to hold an End-of-Phase 2 meeting with the FDA in Q1 2026 to align on its chronic cough treatment program, which aims to advance the clinical development of Haduvio.
- Clinical Trial Initiation: The company expects to initiate a Phase 2b trial for refractory chronic cough in the first half of 2026, providing new treatment options for patients with high unmet needs in this area.
- Market Demand Analysis: In the U.S., approximately 150,000 patients with idiopathic pulmonary fibrosis face uncontrolled chronic cough, indicating significant market potential and urgency for this treatment, which could greatly enhance patient quality of life.
- Strategic Execution Plan: The CEO of Trevi stated that 2026 will be a pivotal year focused on advancing Haduvio's clinical development, aiming to provide effective treatment solutions for chronic cough patients and further solidify its position in the biopharmaceutical sector.
See More
Harvest Announces 2025 ETF Reinvested Distributions
- Annual Reinvested Distributions: Harvest Portfolios Group has announced the final annual reinvested distributions for its ETFs for the 2025 tax year, with all distributions being non-cash, ensuring that the number of units held and the net asset value of the ETFs remain unchanged, thereby maintaining asset stability for investors.
- Tax Implications Explained: The distributions will be reported as taxable, which will increase each unitholder's adjusted cost base, impacting future tax handling and ensuring investors are aware of their tax responsibilities.
- Distribution Details Update: All final reinvested capital gain and income distributions for Harvest ETFs are reported as zero, reflecting the company's cautious strategy in the current market environment aimed at protecting investor interests.
- Enhanced Information Transparency: Harvest commits to reporting the actual taxable amounts and nature of distributions to brokers through CDS in early 2026, enhancing transparency and aiding investors in making informed decisions.
See More
Harvest Announces Final Annual Reinvested Distributions for 2025 Tax Year
- Reinvestment Distribution Announcement: Harvest Portfolios Group Inc. announces the final annual reinvested distributions for its ETFs for the 2025 tax year, with all distributions being non-cash, ensuring that the number of units held and the net asset value of the ETFs remain unchanged.
- Tax Implications Explained: The distributions will be reported as taxable, expected to be communicated to brokers through CDS in early 2026, which will increase each unitholder's adjusted cost base and impact future tax considerations.
- Distribution Details Update: All Harvest ETFs report zero reinvested capital gain and income distributions, indicating no distributable earnings for the year, which may affect investor return expectations.
- Record Date Set: December 31, 2025, is established as the ex-dividend date for all unitholders of record, ensuring investors are informed of distribution details to make timely investment decisions.
See More
Harvest ETFs Updates 2025 Estimated Reinvested Distributions
- Distribution Amount Revision: Harvest has announced a revision of the estimated reinvested distributions for 2025, which will be reported to brokers through CDS in early 2026, ensuring investors are informed about tax implications.
- Non-Cash Distribution Mechanism: The annual distributions for all Harvest ETFs will be reinvested in a non-cash format, ensuring that the number of units held and the net asset value remain unchanged, thereby maintaining asset stability for investors.
- Tax Implications Explained: The reinvested distributions will be treated as taxable distributions, increasing each unitholder's adjusted cost base, which will impact future tax planning.
- Final Distribution Announcement: Harvest expects to announce the final year-end reinvested distribution amounts around December 31, 2025, ensuring investors receive timely access to critical information.
See More
