Trevi Therapeutics Initiates Two Late-Stage Trials for Haduvio
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Mar 09 2026
0mins
Should l Buy TRVI?
Source: stocktwits
- 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.
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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: 11.930
Low
16.00
Averages
21.22
High
25.00
Current: 11.930
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 to Participate in Multiple Healthcare Conferences
- Management Participation: Trevi Therapeutics' senior management will participate in the 25th Annual Needham Virtual Healthcare Conference from April 13-16, 2026, showcasing their research progress on chronic cough, which is expected to enhance investor interest in the company's R&D efforts.
- Key Event Schedule: The company will present its Haduvio™ therapy at the Raymond James 2026 Biotech Innovation Symposium on April 14, 2026, aiming to attract potential investors and strengthen market awareness.
- Investor Day Activities: Trevi plans to hold an Investor and Analyst Day on May 7, 2026, in New York, inviting key opinion leaders in chronic cough to enhance engagement and trust with investors.
- Chronic Cough Market Demand: Trevi's Haduvio™ addresses the urgent needs of approximately 150,000 U.S. patients with IPF and 230,000 with non-IPF ILD, highlighting its strategic significance in a market with high unmet medical needs.
See More
Trevi Therapeutics (TRVI) Earnings Transcript
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Trevi Therapeutics Reports Narrowed Losses and Trial Updates
- Improved Financials: Trevi Therapeutics reported a net loss of $8.32 million for Q4 2025, translating to a loss of $0.06 per share, which is an improvement from the previous year's loss of $11.42 million or $0.11 per share, potentially boosting investor confidence in the company's financial health.
- Clinical Trial Progress: Following a meeting with the FDA, Trevi has secured alignment for its Phase 3 trial program for Nalbuphine ER, with plans to initiate the first trial in Q2 2026, which could provide new treatment options for chronic cough patients and further advance the company's product pipeline.
- Strong Cash Position: Trevi ended 2025 with $188.3 million in cash and equivalents, ensuring a cash runway into 2028, which supports the company's ongoing research and operational activities over the next few years.
- Investor Day Announcement: The company plans to host an Investor and Analyst Day on May 7, 2026, to discuss its clinical and commercial strategies, aiming to enhance market awareness and transparency regarding its future developments.
See More
Trevi Therapeutics Reports Key Insights from Q4 2025 Earnings Call
- Clinical Trial Progress: Trevi Therapeutics received positive FDA feedback for its IPF-related chronic cough program in 2025, with plans to initiate two pivotal Phase III trials in Q2 2026, enrolling approximately 300 and 130 patients respectively, thereby laying the groundwork for a future NDA submission.
- Strong Financial Position: As of year-end 2025, the company reported a cash, cash equivalents, and marketable securities balance of $188 million, providing an operational runway into 2028, ensuring the acquisition of critical data in key clinical trials.
- New CFO Appointment: The addition of David Hastings as the new CFO is seen as a significant step as the company enters a critical execution phase, emphasizing the importance of capital sufficiency in achieving clinical milestones.
- Optimistic Market Outlook: Management expressed optimism regarding future clinical trials and collaboration with the FDA, planning to submit a supplemental NDA for non-IPF ILD-related chronic cough in 2026, demonstrating the company's strategic commitment to addressing unmet medical needs.
See More
Trevi Therapeutics Advances Clinical Trials with Positive Data
- Clinical Trial Progress: Trevi Therapeutics reported positive data from the CORAL and RIVER trials, driving growth and capital raising, indicating strong potential in the IPF-related chronic cough space.
- Strong Cash Position: With approximately $188 million in cash and cash equivalents at the end of 2025, the company expects its runway to extend into 2028, providing essential support for key clinical milestones and ensuring smooth R&D activities.
- Successful FDA Meeting: The company had a successful end of Phase II meeting with the FDA, gaining alignment on the path to NDA, reflecting positive progress in regulatory compliance.
- Clear Trial Design: Trevi plans to initiate two pivotal Phase III clinical trials with clear timelines and trial designs, which will help enhance the likelihood of trial success and improve market competitiveness.
See More
Trevi Therapeutics Q4 Earnings Beat Expectations
- Earnings Beat: Trevi Therapeutics reported a GAAP EPS of -$0.06 for Q4 2025, exceeding expectations by $0.04, indicating an improvement in financial performance.
- Strong Cash Reserves: The company ended 2025 with $188.3 million in cash, cash equivalents, and marketable securities, providing a cash runway expected to last until 2028, which enhances financial stability and future investment capacity.
- Increase in Other Income: Other income for Q4 2025 rose to $1.9 million from $0.8 million in the same period of 2024, primarily due to increased interest income from higher balances of invested cash equivalents and marketable securities, reflecting effective asset management.
- Reduced Net Loss: Trevi reported a net loss of $8.3 million in Q4 2025, down from a net loss of $11.4 million in Q4 2024, indicating progress in cost control and operational efficiency improvements.
See More
Trevi Therapeutics to Participate in Multiple Healthcare Conferences
- Management Participation: Trevi Therapeutics' senior management will participate in the 25th Annual Needham Virtual Healthcare Conference from April 13-16, 2026, showcasing their research progress on chronic cough, which is expected to enhance investor interest in the company's R&D efforts.
- Key Event Schedule: The company will present its Haduvio™ therapy at the Raymond James 2026 Biotech Innovation Symposium on April 14, 2026, aiming to attract potential investors and strengthen market awareness.
- Investor Day Activities: Trevi plans to hold an Investor and Analyst Day on May 7, 2026, in New York, inviting key opinion leaders in chronic cough to enhance engagement and trust with investors.
- Chronic Cough Market Demand: Trevi's Haduvio™ addresses the urgent needs of approximately 150,000 U.S. patients with IPF and 230,000 with non-IPF ILD, highlighting its strategic significance in a market with high unmet medical needs.
See More
Trevi Therapeutics (TRVI) Earnings Transcript
See More
Trevi Therapeutics Reports Narrowed Losses and Trial Updates
- Improved Financials: Trevi Therapeutics reported a net loss of $8.32 million for Q4 2025, translating to a loss of $0.06 per share, which is an improvement from the previous year's loss of $11.42 million or $0.11 per share, potentially boosting investor confidence in the company's financial health.
- Clinical Trial Progress: Following a meeting with the FDA, Trevi has secured alignment for its Phase 3 trial program for Nalbuphine ER, with plans to initiate the first trial in Q2 2026, which could provide new treatment options for chronic cough patients and further advance the company's product pipeline.
- Strong Cash Position: Trevi ended 2025 with $188.3 million in cash and equivalents, ensuring a cash runway into 2028, which supports the company's ongoing research and operational activities over the next few years.
- Investor Day Announcement: The company plans to host an Investor and Analyst Day on May 7, 2026, to discuss its clinical and commercial strategies, aiming to enhance market awareness and transparency regarding its future developments.
See More
Trevi Therapeutics Reports Key Insights from Q4 2025 Earnings Call
- Clinical Trial Progress: Trevi Therapeutics received positive FDA feedback for its IPF-related chronic cough program in 2025, with plans to initiate two pivotal Phase III trials in Q2 2026, enrolling approximately 300 and 130 patients respectively, thereby laying the groundwork for a future NDA submission.
- Strong Financial Position: As of year-end 2025, the company reported a cash, cash equivalents, and marketable securities balance of $188 million, providing an operational runway into 2028, ensuring the acquisition of critical data in key clinical trials.
- New CFO Appointment: The addition of David Hastings as the new CFO is seen as a significant step as the company enters a critical execution phase, emphasizing the importance of capital sufficiency in achieving clinical milestones.
- Optimistic Market Outlook: Management expressed optimism regarding future clinical trials and collaboration with the FDA, planning to submit a supplemental NDA for non-IPF ILD-related chronic cough in 2026, demonstrating the company's strategic commitment to addressing unmet medical needs.
See More
Trevi Therapeutics Advances Clinical Trials with Positive Data
- Clinical Trial Progress: Trevi Therapeutics reported positive data from the CORAL and RIVER trials, driving growth and capital raising, indicating strong potential in the IPF-related chronic cough space.
- Strong Cash Position: With approximately $188 million in cash and cash equivalents at the end of 2025, the company expects its runway to extend into 2028, providing essential support for key clinical milestones and ensuring smooth R&D activities.
- Successful FDA Meeting: The company had a successful end of Phase II meeting with the FDA, gaining alignment on the path to NDA, reflecting positive progress in regulatory compliance.
- Clear Trial Design: Trevi plans to initiate two pivotal Phase III clinical trials with clear timelines and trial designs, which will help enhance the likelihood of trial success and improve market competitiveness.
See More
Trevi Therapeutics Q4 Earnings Beat Expectations
- Earnings Beat: Trevi Therapeutics reported a GAAP EPS of -$0.06 for Q4 2025, exceeding expectations by $0.04, indicating an improvement in financial performance.
- Strong Cash Reserves: The company ended 2025 with $188.3 million in cash, cash equivalents, and marketable securities, providing a cash runway expected to last until 2028, which enhances financial stability and future investment capacity.
- Increase in Other Income: Other income for Q4 2025 rose to $1.9 million from $0.8 million in the same period of 2024, primarily due to increased interest income from higher balances of invested cash equivalents and marketable securities, reflecting effective asset management.
- Reduced Net Loss: Trevi reported a net loss of $8.3 million in Q4 2025, down from a net loss of $11.4 million in Q4 2024, indicating progress in cost control and operational efficiency improvements.
See More
