Trevi Therapeutics Reaches Alignment with FDA on Phase 2 Meeting
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 2 days ago
0mins
Should l Buy TRVI?
Trevi Therapeutics announced the results of its End-of-Phase 2 meeting with the U.S. Food and Drug Administration, FDA. At the meeting, the Company gained overall alignment on the plan for the remaining development program. 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 the New Drug Application, NDA, submission. The Company plans to conduct the Phase 3 trials in parallel with each other 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.
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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: 11.760
Low
16.00
Averages
21.22
High
25.00
Current: 11.760
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 Initiates Two Late-Stage Trials for Haduvio
- Trial Arrangement: Trevi Therapeutics announced the initiation of two late-stage clinical trials, opting for a parallel approach despite FDA guidance suggesting only one pivotal trial, indicating a cautious strategy in drug development.
- Trial Scale and Design: The first trial plans to enroll about 300 patients while the second is expected to enroll 130 patients, both being randomized, placebo-controlled, multicenter global trials aimed at assessing Haduvio's impact on cough frequency in patients with idiopathic pulmonary fibrosis.
- Market Reaction: Trevi Therapeutics' stock fell 12% following the announcement of the dual trials, reflecting investor concerns over the company's conservative strategy, although analysts maintain a 'Buy' rating with a target price of $21.55, suggesting an upside potential of over 80%.
- Patient Need and Market Opportunity: Patients with idiopathic pulmonary fibrosis may cough up to 1500 times a day, and with no FDA-approved therapies available, Haduvio presents a significant market opportunity that could address this unmet medical need if approved.
See More
Trevi Therapeutics Initiates Two Phase 3 Trials for Chronic Cough Treatment
- Clinical Trial Plans: Trevi Therapeutics announced the initiation of two Phase 3 clinical trials to evaluate the efficacy of oral nalbuphine ER for patients with idiopathic pulmonary fibrosis (IPF)-related chronic cough, with the first trial expected to start in Q2 2026 and the second in the second half of 2026.
- FDA Meeting Outcomes: The company received overall alignment on the remaining development program during a meeting with the U.S. FDA, clarifying the path forward for clinical studies to support the New Drug Application (NDA), indicating a positive stance from the FDA on the project.
- Trial Design Details: Both trials will be randomized, double-blind, placebo-controlled global studies, with the first planned to enroll approximately 300 patients and the second about 130 patients, primarily assessing the relative change in 24-hour cough frequency.
- Market Demand Context: Currently, there are about 150,000 IPF patients in the U.S., with two-thirds facing uncontrolled chronic cough, highlighting a significant unmet need in this area, and Trevi's Haduvio is poised to address this gap.
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
Trevi Therapeutics Initiates Two Late-Stage Trials for Haduvio
- Trial Arrangement: Trevi Therapeutics announced the initiation of two late-stage clinical trials, opting for a parallel approach despite FDA guidance suggesting only one pivotal trial, indicating a cautious strategy in drug development.
- Trial Scale and Design: The first trial plans to enroll about 300 patients while the second is expected to enroll 130 patients, both being randomized, placebo-controlled, multicenter global trials aimed at assessing Haduvio's impact on cough frequency in patients with idiopathic pulmonary fibrosis.
- Market Reaction: Trevi Therapeutics' stock fell 12% following the announcement of the dual trials, reflecting investor concerns over the company's conservative strategy, although analysts maintain a 'Buy' rating with a target price of $21.55, suggesting an upside potential of over 80%.
- Patient Need and Market Opportunity: Patients with idiopathic pulmonary fibrosis may cough up to 1500 times a day, and with no FDA-approved therapies available, Haduvio presents a significant market opportunity that could address this unmet medical need if approved.
See More
Trevi Therapeutics Initiates Two Phase 3 Trials for Chronic Cough Treatment
- Clinical Trial Plans: Trevi Therapeutics announced the initiation of two Phase 3 clinical trials to evaluate the efficacy of oral nalbuphine ER for patients with idiopathic pulmonary fibrosis (IPF)-related chronic cough, with the first trial expected to start in Q2 2026 and the second in the second half of 2026.
- FDA Meeting Outcomes: The company received overall alignment on the remaining development program during a meeting with the U.S. FDA, clarifying the path forward for clinical studies to support the New Drug Application (NDA), indicating a positive stance from the FDA on the project.
- Trial Design Details: Both trials will be randomized, double-blind, placebo-controlled global studies, with the first planned to enroll approximately 300 patients and the second about 130 patients, primarily assessing the relative change in 24-hour cough frequency.
- Market Demand Context: Currently, there are about 150,000 IPF patients in the U.S., with two-thirds facing uncontrolled chronic cough, highlighting a significant unmet need in this area, and Trevi's Haduvio is poised to address this gap.
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
