Trevi Therapeutics, Inc.

https://www.trevitherapeutics.com

Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company dedicated to developing therapies for neurologically mediated conditions, primarily focusing on chronic cough. Founded in 2011, the company's mission is to improve the lives of patients suffering from these debilitating conditions. Its headquarters are located in New Haven, Connecticut, at 195 Church Street, 16th Floor. [4, 6, 10, 18, 22, 24, 26]

The company's key product is Haduvio™ (oral nalbuphine extended-release), an investigational therapy. [3, 5, 6, 10, 12, 13, 16, 19, 22, 23, 24, 25, 26] Haduvio operates as a mixed kappa-opioid receptor agonist and mu-opioid receptor antagonist (KAMA), targeting opioid receptors involved in the central and peripheral cough reflex arc. [12, 16, 25] Trevi Therapeutics is developing Haduvio for chronic cough associated with Idiopathic Pulmonary Fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC), areas where there are currently no FDA-approved therapies. [3, 6, 10, 12, 13, 16, 19, 22, 23, 25]

In recent news, Trevi Therapeutics reported its year-end 2025 financial results and clinical updates on March 17, 2026, projecting a cash runway into 2028. [3, 20] The company achieved FDA alignment following an End-of-Phase 2 meeting for IPF-related chronic cough and plans to initiate two Phase 3 trials in Q2 and H2 2026, alongside Phase 2b trials for RCC and non-IPF ILD. [3, 9, 12, 20, 25] In April 2026, Trevi Therapeutics completed an underwritten public offering, raising approximately $173 million in gross proceeds. [2, 3] Jennifer Good serves as the Co-Founder, President & CEO, with David Hastings appointed as Chief Financial Officer effective January 6, 2026. [6, 9, 11, 24, 26] The company is positioned as a clinical-stage biopharmaceutical firm focused on addressing significant unmet medical needs with its lead candidate, Haduvio. [25, 26]

Latest updates

Trevi Data Suggests Potential for Nalbuphine in ILD Cough Management

Event summary

  • Trevi Therapeutics will present oral and poster data at the ATS 2026 International Conference (May 15-20) regarding its nalbuphine ER therapy.
  • The oral presentation focuses on primary and subgroup analyses from the Phase 2b CORAL trial in IPF patients, while posters explore drug-drug interactions and effects on cough bouts.
  • Data from the Phase 2a RIVER trial, evaluating nalbuphine ER in patients with refractory chronic cough, will also be presented.
  • The CORAL trial involved 165 patients randomized across four arms (three nalbuphine doses and placebo) over a 6-week period.
  • Nalbuphine is being developed as Haduvio™ for IPF, non-IPF ILD, and RCC, targeting a combined U.S. patient population of approximately 300,000.

The big picture

Trevi's focus on chronic cough in IPF and related ILDs addresses a significant unmet need, given the lack of FDA-approved therapies for this debilitating symptom. The company's KAMA mechanism of action differentiates it from existing treatments, but clinical data and regulatory acceptance remain key hurdles. The presentation at ATS provides a crucial opportunity to validate the clinical utility of nalbuphine ER and advance its development program.

What we're watching

Clinical Efficacy
The full ATS presentation data will be critical in assessing the clinical significance of nalbuphine's impact on cough frequency and breathlessness in IPF patients, beyond the topline results already released.
Regulatory Pathway
The drug-drug interaction data with pirfenidone and nintedanib will inform potential combination therapy strategies and could influence the regulatory pathway for Haduvio™.
Commercialization
The survey data on the burden of chronic cough in ILD will be valuable for Trevi in shaping its commercialization strategy and demonstrating the unmet need for a targeted therapy.

Trevi Therapeutics to Detail Q1 Results Amidst Unmet Cough Treatment Need

Event summary

  • Trevi Therapeutics will report Q1 2026 financial results and provide a corporate update on May 5, 2026, at 4:30 p.m. ET.
  • The company is developing Haduvio™ (oral nalbuphine ER) for chronic cough in IPF, non-IPF ILD, and RCC.
  • Haduvio is the only therapy demonstrating statistically significant cough reduction across IPF and RCC clinical trials.
  • Approximately 2-3 million U.S. patients suffer from refractory chronic cough (RCC).

The big picture

Trevi Therapeutics is targeting a significant unmet need in the respiratory therapeutics space, addressing a condition affecting hundreds of thousands of patients with limited treatment options. The company’s focus on a novel mechanism of action (KAMA) and the potential for a first-in-class therapy positions it for substantial market opportunity, but also exposes it to the inherent risks of clinical development and regulatory approval. The company's valuation will be heavily influenced by the outcome of ongoing and future clinical trials.

What we're watching

Clinical Adoption
The success of Haduvio will hinge on physician adoption, which will depend on real-world efficacy data beyond the initial clinical trials and its differentiation from existing, albeit inadequate, treatments.
Regulatory Pathway
While nalbuphine isn't currently scheduled by the DEA, any potential shift in regulatory classification could significantly impact Haduvio's commercial viability and market access.
Market Penetration
Given the prevalence of chronic cough and the lack of approved therapies, Trevi's ability to capture a meaningful share of the patient population will be crucial for long-term financial success.

Trevi Therapeutics Schedules Investor Events Ahead of Key Data Presentations

Event summary

  • Trevi Therapeutics will host an Investor and Analyst Day on May 7, 2026, in New York City.
  • Jennifer Good (President & CEO) and David Hastings (CFO) will present at the Bank of America Global Healthcare Conference on May 12-13, 2026, in Las Vegas.
  • A data highlights event featuring Philip Molyneaux and James Cassella will be held on May 18, 2026, in Orlando, coinciding with the ATS International Conference.
  • Haduvio™ (oral nalbuphine ER) is being developed for chronic cough in IPF, non-IPF ILD, and RCC, targeting a combined patient population of roughly 370,000 U.S. patients.

The big picture

Trevi Therapeutics is attempting to address a significant unmet need in chronic cough management, a condition affecting a substantial patient population with limited treatment options. The company's reliance on clinical trial data and key opinion leader endorsements to drive investor confidence highlights the inherent risks associated with late-stage drug development. The upcoming events represent a critical juncture for the company to demonstrate the value proposition of Haduvio and secure future funding.

What we're watching

Clinical Data
The data presented at the ATS conference will be crucial in assessing Haduvio’s efficacy and safety profile, potentially influencing regulatory pathways and investor sentiment.
Commercialization
The success of Trevi’s investor outreach, particularly at the Analyst Day, will indicate the level of institutional interest and potential for future funding or partnerships.
Regulatory Risk
While nalbuphine is not currently scheduled by the DEA, any future changes in regulatory classification could significantly impact Haduvio’s commercial viability.

Trevi Therapeutics Lands $173 Million Funding Boost

Event summary

  • Trevi Therapeutics completed a public offering of 13,340,000 shares at $13.00 per share.
  • The offering, including the underwriters’ option, raised approximately $173 million in net proceeds.
  • Morgan Stanley, Leerink Partners, Cantor, and Stifel acted as joint book-running managers, with Oppenheimer & Co. as lead manager.
  • The offering was conducted under a shelf registration statement filed with the SEC on November 13, 2025.

The big picture

The successful offering underscores investor appetite for clinical-stage biopharmaceutical companies with differentiated therapies targeting significant unmet needs. Trevi's focus on chronic cough in IPF, ILD, and RCC represents a relatively underserved market, but the company faces the inherent risks associated with drug development and regulatory approval. The $173 million raise provides a buffer, but execution on clinical milestones will be critical to sustaining this valuation.

What we're watching

Cash Runway
The substantial capital infusion extends Trevi’s cash runway, likely enabling continued clinical development of Haduvio and supporting pre-commercialization activities, but the burn rate will be a key indicator of long-term viability.
Clinical Trial Progress
The success of Haduvio's development and eventual regulatory approval remains the primary driver of Trevi's valuation; progress in ongoing clinical trials will be crucial to maintaining investor confidence.
Market Adoption
Given the niche nature of IPF and RCC treatments, the pace at which physicians adopt Haduvio, if approved, will significantly impact revenue generation and the company's ability to achieve profitability.

Trevi Therapeutics Raises $150 Million in Stock Offering

Event summary

  • Trevi Therapeutics priced its public offering of 11.6 million shares at $13.00 per share, raising approximately $150 million.
  • The company has a 30-day option to issue an additional 1.74 million shares.
  • The offering is expected to close on April 20, 2026.
  • Proceeds will be used to fund ongoing clinical trials and general corporate purposes.
  • The offering was made under a shelf registration statement filed with the SEC on November 13, 2025.

The big picture

The $150 million capital raise provides Trevi Therapeutics with a substantial runway to advance Haduvio through late-stage clinical trials and potentially towards regulatory submission. This offering underscores the continued investor interest in therapies targeting chronic cough, a significant unmet medical need with a growing patient population. However, the dilution associated with the offering will likely put pressure on the company to demonstrate rapid progress and positive clinical data.

What we're watching

Execution Risk
The success of Trevi's clinical trials for Haduvio remains the primary driver of its valuation, and the influx of capital will be scrutinized for efficient allocation to these efforts.
Market Dynamics
Given the dilution effect of the offering, investor sentiment will be sensitive to any setbacks or delays in Haduvio’s development and regulatory approval pathway.
Regulatory Headwinds
The FDA's eventual assessment of Haduvio’s efficacy and safety profile, particularly concerning its opioid receptor activity, will significantly impact its commercial viability and market access.

Trevi Therapeutics Seeks $150 Million in Public Offering

Event summary

  • Trevi Therapeutics has announced a proposed public offering of $150 million in common stock.
  • The underwriters have an option to purchase an additional $22.5 million worth of shares.
  • Morgan Stanley, Leerink Partners, Cantor, Stifel, and Oppenheimer & Co. are acting as advisors for the offering.
  • The offering is being made under a shelf registration statement filed with the SEC on November 13, 2025.
  • Haduvio™ (oral nalbuphine ER) is Trevi's investigational therapy for chronic cough.

The big picture

This offering suggests Trevi is seeking to bolster its financial position to support the development and potential commercialization of Haduvio, its lead drug candidate. The size of the offering ($150 million) indicates a significant capital need, likely driven by the costs associated with late-stage clinical trials and potential regulatory approval. The reliance on a shelf registration suggests a desire for flexibility and speed in accessing capital markets.

What we're watching

Market Conditions
The success of the offering hinges on prevailing market conditions, which have been volatile; a failure to execute at the proposed terms would signal investor skepticism about Trevi's valuation or pipeline.
Pipeline Progress
How quickly Trevi can advance Haduvio through clinical trials and regulatory review will dictate the long-term value proposition for investors, particularly given the competitive landscape in cough therapies.
Capital Needs
The proceeds from this offering will likely fund ongoing clinical trials and commercialization efforts; the burn rate and efficiency of capital deployment will be critical to maintaining financial stability.

Trevi Therapeutics Schedules Investor Roadshow Ahead of Key Data Readouts

Event summary

  • Trevi Therapeutics will participate in the Needham Virtual Healthcare Conference (April 13-16), the Raymond James Biotech Innovation Symposium (April 14), and Oppenheimer’s Innovation on the Island (April 27-29).
  • The company will host an Investor and Analyst Day on May 7 in New York City, featuring key opinion leaders in chronic cough.
  • Jennifer Good (CEO) and David Hastings (CFO) will represent Trevi at all listed events.
  • Haduvio™ (nalbuphine ER) is the company’s investigational therapy targeting chronic cough in IPF, non-IPF ILD, and RCC.

The big picture

Trevi’s investor events coincide with a period of heightened scrutiny for companies targeting rare respiratory diseases. The company’s reliance on Haduvio to address a significant unmet need—affecting hundreds of thousands of patients—positions it for potential success, but also exposes it to considerable clinical and regulatory risk. The upcoming Investor and Analyst Day will be a key indicator of investor confidence and the perceived value of Trevi’s KAMA mechanism of action.

What we're watching

Data Dependency
The success of Trevi's investor roadshow and subsequent valuation will be heavily influenced by the reception of Haduvio's clinical trial data, particularly regarding efficacy and safety.
Regulatory Risk
While nalbuphine is not currently scheduled by the DEA, any future changes to regulatory status could significantly impact Haduvio's commercial viability and market access.
Competition
The lack of FDA-approved therapies for RCC and IPF-related cough creates a large market opportunity, but the emergence of competing therapies could erode Haduvio’s potential market share.

Trevi Therapeutics Secures FDA Alignment, Advances Cough Therapies

Event summary

  • Trevi Therapeutics received FDA alignment on its Phase 3 program for IPF-related chronic cough following an End-of-Phase 2 meeting.
  • The company plans to initiate a Phase 2b clinical trial for refractory chronic cough (RCC) in Q2 2026.
  • Trevi Therapeutics ended 2025 with $188.3 million in cash, projecting a runway into 2028.
  • R&D expenses decreased in 2025 to $33.5 million, primarily due to the completion of prior-year clinical trials.

The big picture

Trevi's FDA alignment represents a significant de-risking event for its lead IPF-related cough program, potentially unlocking substantial value given the unmet need in this patient population. The company's focus on RCC and non-IPF ILD expands its addressable market, but also introduces additional clinical and regulatory hurdles. The current cash position provides breathing room, but successful execution of the upcoming trials is paramount to long-term success.

What we're watching

Clinical Execution
The success of the two parallel Phase 3 trials for IPF-related cough will be critical, given the agreement with the FDA hinges on their design and outcomes. Any deviations from the planned enrollment or dosing could significantly impact the timeline and potential approval.
Cash Management
While the current cash runway extends into 2028, the initiation of multiple Phase 2b and Phase 3 trials will accelerate burn. Monitoring the company's ability to maintain this runway without additional financing will be essential.
Competitive Landscape
Given the lack of FDA-approved therapies for RCC, Trevi faces a potential first-mover advantage. However, the emergence of alternative treatments or competing approaches could erode market share and impact commercial viability.

Trevi Therapeutics to Detail 2025 Results Amidst Unmet Cough Treatment Need

Event summary

  • Trevi Therapeutics will report Q4 and FY2025 financial results and provide business updates on March 17, 2026, at 4:30 PM ET.
  • The company is developing Haduvio™ (oral nalbuphine ER) for chronic cough in IPF, non-IPF ILD, and RCC.
  • Haduvio is the only therapy demonstrating statistically significant cough reduction across IPF and RCC patients in clinical trials.
  • Approximately 2-3 million U.S. patients suffer from refractory chronic cough (RCC), a condition with no FDA-approved therapies.
  • Trevi intends to propose Haduvio as the trade name for oral nalbuphine ER, which has not been evaluated by any regulatory authority.

The big picture

Trevi Therapeutics is targeting a significant unmet need in chronic cough management, a condition affecting hundreds of thousands of patients with IPF, ILD, and RCC. The lack of FDA-approved therapies for RCC creates a substantial commercial opportunity, but success will depend on demonstrating clinical benefit and navigating a complex regulatory landscape. The company’s focus on a unique mechanism of action (KAMA) presents both a potential advantage and a risk, as it may require a novel regulatory approach.

What we're watching

Clinical Adoption
The success of Haduvio will hinge on physician adoption and patient willingness to try a novel treatment approach for a condition often managed with multiple therapies.
Regulatory Pathway
The FDA’s assessment of Haduvio’s efficacy and safety profile, particularly given its unique mechanism of action, will dictate the timeline and potential scope of commercialization.
Market Penetration
Trevi’s ability to capture market share within the large RCC patient population will depend on effective marketing and reimbursement strategies, given the existing treatment landscape.

Trevi Therapeutics Secures FDA Alignment for IPF Cough Treatment

Event summary

  • Trevi Therapeutics has completed an End-of-Phase 2 meeting with the FDA regarding its Haduvio™ (nalbuphine ER) therapy for IPF-related chronic cough.
  • The FDA has aligned with Trevi's plan to conduct two pivotal Phase 3 clinical trials, expected to begin in Q2 2026 and H2 2026, respectively.
  • The Phase 3 trials will enroll approximately 300 and 130 patients, respectively, and will assess cough frequency as a primary endpoint.
  • Haduvio is the only investigational therapy to demonstrate statistically significant cough reduction in both IPF and refractory chronic cough patients.

The big picture

Trevi’s progress represents a potential breakthrough in addressing a significant unmet need within the IPF patient population, a market estimated to be worth hundreds of millions annually. The FDA alignment de-risks the development pathway, but the success of Haduvio remains contingent on the results of the Phase 3 trials and the company’s ability to navigate the regulatory and commercial landscape. The lack of existing therapies highlights the potential for a first-mover advantage, but also underscores the pressure to deliver meaningful clinical benefit.

What we're watching

Trial Execution
The parallel Phase 3 trial design introduces complexity; successful, concurrent execution will be critical for timely data generation and potential approval.
Endpoint Validation
Reliance on an objective cough monitor as the primary endpoint necessitates careful scrutiny of its reliability and correlation with patient-reported outcomes.
Commercial Adoption
Given the limited treatment options and significant burden of IPF-related cough, the success of Haduvio will hinge on physician and patient adoption, which will be influenced by efficacy and safety data.

Trevi Therapeutics to Present at Key Investor and Rare Disease Forums

Event summary

  • Trevi Therapeutics executives Jennifer Good (President & CEO) and James Cassella (CDO) will participate in the Leerink Partners Healthcare Conference on March 11th.
  • Farrell Simon (CCO) will participate in the Access USA Rare Disease Summit on March 18th.
  • Haduvio™ (oral nalbuphine ER) is Trevi's investigational therapy targeting chronic cough in IPF, non-IPF ILD, and RCC.
  • The company estimates ~150,000 U.S. patients with IPF and ~228,000 with non-IPF ILD experience uncontrolled chronic cough.

The big picture

Trevi’s focus on chronic cough within IPF, non-IPF ILD, and RCC represents a strategic bet on a significant unmet need with limited existing therapeutic options. The company’s participation in these conferences underscores the importance of investor and specialist engagement in driving Haduvio’s development and potential commercialization, given the challenges inherent in rare disease drug development and the competitive landscape of respiratory therapies.

What we're watching

Investor Sentiment
The content of the Fireside Chat at Leerink will likely shape near-term investor perception of Haduvio’s development and commercial prospects, particularly given the competitive landscape in cough therapies.
Rare Disease Focus
Trevi’s participation in the Rare Disease Summit signals a deliberate effort to engage with specialists and build awareness, which will be crucial for navigating the complexities of rare disease drug launches.
Regulatory Pathway
The lack of scheduling by the U.S. Drug Enforcement Agency for nalbuphine provides a potential advantage, but the FDA’s eventual assessment of Haduvio’s safety and efficacy will be the ultimate determinant of its market access.

Trevi Therapeutics to Detail Haduvio Progress at Oppenheimer Conference

Event summary

  • Trevi Therapeutics CEO Jennifer Good and CFO David Hastings will participate in a fireside chat at the Oppenheimer Healthcare Life Sciences Conference on February 25, 2026.
  • The conference is virtual and will be held February 25-26, 2026.
  • Haduvio™ (oral nalbuphine ER) is Trevi's investigational therapy targeting chronic cough in IPF, non-IPF ILD, and RCC.
  • The company estimates ~150,000 U.S. patients with IPF and ~228,000 with non-IPF ILD experience uncontrolled chronic cough.

The big picture

Trevi Therapeutics is targeting a significant unmet need in chronic cough management, a condition affecting hundreds of thousands of patients with IPF, ILD, and RCC. The lack of FDA-approved therapies creates a substantial market opportunity, but the company faces challenges in demonstrating efficacy and navigating regulatory hurdles. The conference participation signals an effort to bolster investor confidence and communicate progress on Haduvio's development.

What we're watching

Clinical Data
The fireside chat will likely focus on Haduvio’s clinical trial results; investor sentiment will hinge on the perceived robustness and potential for regulatory approval.
Market Adoption
Given the large patient populations with IPF, non-IPF ILD, and RCC, the success of Haduvio will depend on the company's ability to effectively reach and treat these patients, and to differentiate from existing, albeit inadequate, therapies.
Regulatory Pathway
While nalbuphine isn’t currently scheduled by the DEA, any future changes in opioid regulation could significantly impact Haduvio’s development and commercialization timeline.
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