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Overview of Trevi Therapeutics, Inc.
Trevi Therapeutics (TRVI) is a clinical-stage biopharmaceutical company dedicated to transforming treatment paradigms for chronic cough and pruritic conditions. The company is deeply involved in the research and development of Haduvio™, an innovative oral extended-release formulation of nalbuphine. Harnessing a unique dual mechanism of action, Haduvio functions as a kappa-opioid receptor agonist and a mu-opioid receptor antagonist. This dual action is central to its potential to provide symptomatic relief in conditions characterized by chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), as well as in dermatologic disorders such as prurigo nodularis.
Scientific and Clinical Rationale
The core of Trevi's approach lies in addressing a significant unmet medical need. In diseases like IPF and RCC, chronic cough is not only debilitating but also correlates with a decline in patients' overall quality of life. Haduvio’s design specifically targets the cough reflex arc through both central and peripheral pathways. By modulating opioid receptors, its mechanism aims to reduce cough frequency and severity without the inherent risks associated with conventional opioid therapies. The investigational therapy is grounded in robust clinical research, with various ongoing trials designed to ascertain its efficacy, safety, and optimal dosing across multiple patient subgroups.
Clinical Development and Research Programs
Trevi Therapeutics is rigorously evaluating Haduvio in numerous clinical settings. The company has instituted several trials, including randomized controlled studies, to evaluate the therapy's impact on 24-hour cough frequency and associated patient-reported outcomes. Key studies include Phase 2a and Phase 2b trials that measure objective cough metrics and patient quality of life indicators. These trials are meticulously designed with endpoints that evaluate both clinical efficacy and potential safety considerations, such as the abuse potential of nalbuphine. Through its comprehensive clinical program, Trevi is focused on gathering robust data that can support regulatory submissions and ultimately provide an alternative treatment where no approved therapies currently exist.
Market Position and Unmet Needs
Chronic cough in IPF and RCC represents a significant area of concern due to the absence of approved treatments in many regions. Trevi Therapeutics positions itself within this niche by offering a therapy that directly targets the underlying physiological mechanisms of cough hypersensitivity. With millions of potential patients and a high prevalence of chronic cough in affected populations, the company addresses the dual challenges of efficacy and patient tolerability using an innovative formulation. This strategic focus on a high unmet need segment bolsters its potential market significance and underscores its commitment to advancing medical science in a challenging therapeutic area.
Operational Excellence and Strategic Considerations
Trevi Therapeutics exhibits a robust operational framework, integrating advanced clinical trial methodologies and state-of-the-art pharmaceutical research. The company's structured approach to trial design, endpoint assessment, and safety evaluation reinforces its authority in the biopharmaceutical domain. Its strategy reflects a nuanced understanding of both the clinical and commercial landscapes, ensuring that scientific precision is coupled with a patient-centric focus. By emphasizing rigorous research, clear strategic milestones, and targeted clinical endpoints, Trevi demonstrates a balanced and expert approach to innovation in therapeutic development.
Conclusion
In summary, Trevi Therapeutics is a forward-thinking clinical-stage biopharmaceutical enterprise poised to redefine treatment standards for chronic cough and pruritic conditions. Through the development of Haduvio™, the company leverages sophisticated pharmacological mechanisms to address significant clinical challenges and empower patients with limited treatment options. Its commitment to comprehensive research, detailed clinical evaluation, and operational excellence cements its role as a critical player in the evolving landscape of respiratory and dermatologic therapeutics.
Trevi Therapeutics (Nasdaq: TRVI), developing Haduvio™ (oral nalbuphine ER) for chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), has announced its participation in three major investor conferences this April 2025.
The company will present at the following events:
- 24th Annual Needham Virtual Healthcare Conference (April 7-10) with a corporate presentation on April 7 at 11:00-11:40 a.m. ET
- Jones Healthcare and Technology Innovation Conference (April 8-9) in Las Vegas, with a presentation on April 9 at 11:00-11:20 a.m. PT
- Piper Sandler Spring Biopharma Symposium (April 16-17) in Boston
Trevi Therapeutics (NASDAQ: TRVI) reported significant progress in its clinical trials for Haduvio, a therapy for chronic cough conditions. The company announced positive topline data from Phase 2a RIVER trial showing a 57% placebo-adjusted reduction in 24-hour cough frequency for refractory chronic cough patients.
Key developments include completed enrollment in the Phase 2b CORAL trial for IPF chronic cough patients, with topline data expected in Q2 2025, and positive sample size re-estimation outcome requiring no changes to the study. The company also reported positive results from its Human Abuse Potential study.
Financial highlights for Q4 2024:
- Cash position: $107.6 million, with runway into H2 2026
- R&D expenses: $9.3 million (up from $6.5M in Q4 2023)
- Net loss: $11.4 million (compared to $7.8M in Q4 2023)
Trevi Therapeutics (NASDAQ: TRVI) has scheduled its fourth quarter and year-end 2024 financial results announcement and corporate update for March 18, 2025, at 4:30 p.m. ET. The company, which is developing Haduvio™ (oral nalbuphine ER) for chronic cough treatment in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), will host a conference call and live audio webcast.
Participants can join via phone at (877) 870 4263 (domestic) or (412) 317 0790 (international). The webcast will be available through the 'Investors & News' section on Trevi's website, with a 30-day replay option available after the event.
Trevi Therapeutics (NASDAQ: TRVI) announced positive topline results from its Phase 2a RIVER trial evaluating Haduvio for refractory chronic cough (RCC). The trial met its primary endpoint with a 57% placebo-adjusted reduction in 24-hour cough frequency (p<0.0001).
Key findings include:
- 67% reduction in cough frequency from baseline
- 66% reduction in severe cough subgroup
- 68% reduction in moderate cough subgroup
- 84% of Haduvio patients achieved at least 30% reduction in cough frequency vs 29% for placebo
The trial involved 66 patients in a randomized, double-blind, placebo-controlled crossover study. Significant improvements were observed as early as Day 7 at the lowest dose (27mg BID). Common side effects included constipation, nausea, somnolence, headache, dizziness, and fatigue, with no serious adverse events reported.
Trevi Therapeutics (NASDAQ: TRVI) has scheduled a conference call and webcast for March 10th, 2025, at 8:30 a.m. ET to present topline results from their Phase 2a RIVER trial of Haduvio™. The trial evaluates oral nalbuphine ER for treating chronic cough in patients with idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC).
The presentation will include audio and slides, accessible via webcast. Participants can join by dialing (877) 870 4263 (domestic) or (412) 317 0790 (international). A 30-day replay will be available on the company's website after the event.
Trevi Therapeutics (Nasdaq: TRVI), focused on developing Haduvio™ (oral nalbuphine ER) for chronic cough treatments, has announced its participation in three major investor conferences this March.
The schedule includes:
- TD Cowen 45th Annual Health Care Conference (March 3-5) in Boston, featuring a corporate presentation on March 4 at 10:30 AM ET by CFO Lisa Delfini and CCO Farrell Simon
- Leerink Partners Global Healthcare Conference (March 10-12) in Miami, with a presentation on March 12 at 8:00 AM ET by CEO Jennifer Good and CDO James Cassella
- Leerink Partners Mountain Meeting (March 23-26) in Jackson Hole, with CFO Lisa Delfini representing
All events will feature corporate presentations available to in-person attendees.
Trevi Therapeutics (NASDAQ: TRVI) has completed enrollment in its Phase 2b CORAL trial of Haduvio™ (oral nalbuphine ER) for treating chronic cough in patients with idiopathic pulmonary fibrosis (IPF). Topline results are expected in the first half of 2025.
The CORAL trial is evaluating three doses of Haduvio (27mg, 54mg, and 108mg twice daily) against placebo in approximately 160 IPF patients with chronic cough over a 6-week period. The study includes a 2-week titration period followed by 4 weeks of fixed dosing.
The primary endpoint measures the relative change in 24-hour cough frequency at Week 6 versus baseline, using an objective cough monitor. Secondary endpoints include patient-reported outcome measures for cough.
According to James Cassella, Chief Development Officer, chronic cough significantly impacts IPF patients, and current treatments are often ineffective, creating a substantial unmet need. Results will help determine optimal doses for the pivotal Phase 3 program.
Trevi Therapeutics (Nasdaq: TRVI), a clinical-stage biopharmaceutical company, has announced its participation in three major investor conferences this February. The company, which is developing Haduvio™ (oral nalbuphine ER) for chronic cough treatment in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), will be represented by key executives at these events.
The conferences include the Piper Sandler Biopharma Mogul Summit (February 2-4) in Park City, Utah, where CFO Lisa Delfini will attend; the Oppenheimer Healthcare 2025 Winter CEO & Investor Summit (February 3-6) in Vail, Colorado, featuring CEO Jennifer Good; and the Oppenheimer 35th Annual Healthcare Life Sciences Virtual Conference (February 11-12), where Jennifer Good and Chief Development Officer James Cassella will deliver a corporate presentation on February 11 at 9:20 AM ET.
Trevi Therapeutics (NASDAQ: TRVI) provided key updates on its clinical trials and financial position. The company completed patient visits for its Phase 2a RIVER trial in refractory chronic cough (RCC), with topline results expected in Q1 2025. The Phase 2b CORAL trial in idiopathic pulmonary fibrosis (IPF) patients with chronic cough is approximately 80% enrolled, with results anticipated in H1 2025.
The company recently announced positive outcomes from both the sample size re-estimation analysis of the Phase 2b CORAL trial and their Human Abuse Potential study. Trevi's preliminary estimate indicates cash, cash equivalents, and marketable securities of $107.6 million as of December 31, 2024, providing runway into H2 2026.
Trevi Therapeutics (TRVI) has announced the pricing of an underwritten offering of 12,500,000 shares of common stock at $4.00 per share, aiming to raise $50 million before deducting underwriting costs. The offering, expected to close on December 17, 2024, includes participation from notable investors such as Adage Capital Partners LP, Frazier Life Sciences, and Vivo Capital.
The company, which is developing Haduvio™ (oral nalbuphine ER) for chronic cough treatment in idiopathic pulmonary fibrosis and refractory chronic cough, is conducting the offering through a shelf registration statement previously filed with the SEC. Leerink Partners, Stifel, and Oppenheimer & Co. are serving as joint book-running managers.
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