Trevi Therapeutics Provides Strategic Updates Ahead of Annual LifeSci Partners Corporate Access Event Held During the J.P. Morgan Healthcare Conference

Rhea-AI Summary

Trevi Therapeutics (Nasdaq: TRVI) provided strategic clinical updates ahead of the LifeSci Partners event (Jan 12-14, 2026) during J.P. Morgan week. The company has an FDA End-of-Phase 2 meeting scheduled in Q1 2026 for nalbuphine ER (Haduvio) for chronic cough in IPF and expects to initiate a Phase 3 program in IPF in H1 2026 following that meeting. Trevi also plans to start a Phase 2b trial in refractory chronic cough (RCC) in H1 2026. New CFO David Hastings will attend the LifeSci event with senior management.

Positive

• FDA End-of-Phase 2 meeting scheduled in Q1 2026
• Planned Phase 3 initiation in IPF in H1 2026
• Planned Phase 2b start in RCC in H1 2026
• New CFO David Hastings engaging at Jan 12-14 investor event

Negative

• Phase 3 start is contingent on FDA meeting outcome
• No clinical efficacy or safety readouts disclosed in this update

News Market Reaction – TRVI

-4.27%

1 alert

-4.27% News Effect

-$64M Valuation Impact

$1.44B Market Cap

0.0x Rel. Volume

On the day this news was published, TRVI declined 4.27%, reflecting a moderate negative market reaction. This price movement removed approximately $64M from the company's valuation, bringing the market cap to $1.44B at that time.

Data tracked by StockTitan Argus on the day of publication.

Key Figures

End-of-Phase 2 meeting timing: First quarter of 2026 Phase 3 start target: First half of 2026 Phase 2b RCC trial start: First half of 2026 +3 more

6 metrics

End-of-Phase 2 meeting timing First quarter of 2026 FDA End-of-Phase 2 meeting for chronic cough in IPF

Phase 3 start target First half of 2026 Planned initiation of Phase 3 program in chronic cough in IPF

Phase 2b RCC trial start First half of 2026 Planned Phase 2b trial in refractory chronic cough

LifeSci event dates January 12–14, 2026 15th Annual LifeSci Partners Corporate Access Event

Development stage Phase 2b Refractory chronic cough trial stage

Planned development stage Phase 3 Upcoming chronic cough in IPF program

Market Reality Check

Price: $10.64 Vol: Volume 2,456,928 is 1.33x...

normal vol

$10.64 Last Close

Volume Volume 2,456,928 is 1.33x the 20-day average of 1,850,379 shares. normal

Technical Price $11.71 is trading above the 200-day MA at $8.45 and 18.6% below the 52-week high of $14.39.

Peers on Argus

TRVI gained 6.65% on strategic chronic cough updates, while high-affinity peers ...

3 Up

TRVI gained 6.65% on strategic chronic cough updates, while high-affinity peers showed mixed moves: DNTH +4.18%, ELVN , GPCR +4.05%, LENZ -4.23%, TRML flat. Momentum scanner flagged other biotech names (AMLX, XERS, NTLA) trending up without same-day news, indicating TRVI’s move was primarily stock-specific.

Historical Context

5 past events · Latest: Dec 04 (Positive)

Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Dec 04	CFO appointment	Positive	-1.0%	New CFO with extensive life-science financing and commercialization experience.
Nov 13	Earnings & updates	Neutral	-3.3%	Q3 2025 financials, strong cash, plans for End-of-Phase 2 and Phase 3 start.
Nov 06	Earnings call date	Neutral	+0.0%	Scheduled Q3 2025 results call and webcast logistics announcement.
Nov 04	Conference participation	Neutral	+1.5%	Participation in Stifel 2025 Healthcare Conference and investor meetings.
Oct 08	Clinical data abstracts	Positive	+2.8%	Phase 2b CORAL and Phase 2a RIVER chronic cough results at CHEST 2025.

Pattern Detected

Recent news—scientific updates, conferences, and earnings—generally aligned with modest positive or negative price moves, with one divergence where a positive CFO appointment coincided with a small decline.

Recent Company History

Over the past six months, Trevi’s news flow highlighted steady clinical and corporate progress. In October 2025, positive Phase 2 chronic cough data presentations at CHEST 2025 were followed by a 2.83% gain. Subsequent conference participation and an earnings-date announcement produced small moves. Q3 2025 results showed a $11.8M net loss but emphasized a cash runway into 2028, with the stock down 3.29%. The December 2025 appointment of an experienced CFO saw a modest 0.99% decline, contrasting with today’s stronger reaction to clear Phase 3 and regulatory timing.

Market Pulse Summary

This announcement provided clearer timing for Trevi’s chronic cough programs, including an FDA End-o...

Analysis

This announcement provided clearer timing for Trevi’s chronic cough programs, including an FDA End-of-Phase 2 meeting in the first quarter of 2026 and plans to start a Phase 3 program in IPF chronic cough and a Phase 2b RCC trial in the first half of 2026. Investors may track whether these milestones occur as scheduled and how upcoming data, regulatory feedback, and financing disclosures interact with the company’s existing cash runway and prior clinical results.

Key Terms

end-of-phase 2, new drug application, idiopathic pulmonary fibrosis, interstitial lung disease, +4 more

8 terms

end-of-phase 2 regulatory

"We have an End-of-Phase 2 meeting scheduled with the FDA..."

End-of-phase 2 is the development milestone when a drug or medical treatment completes its mid-stage human testing and the sponsor and regulators review the results to decide whether and how to proceed to larger late-stage trials. It matters to investors because this review signals whether the product showed enough benefit and acceptable safety to justify expensive Phase 3 studies, much like passing a major exam before committing to the final, costly year of a degree, and can materially affect a company’s value and funding needs.

new drug application regulatory

"regulatory pathway for the New Drug Application of nalbuphine ER..."

A new drug application is a formal request submitted to government regulators seeking approval to market a new medicine. It is like a detailed proposal that shows the drug has been tested for safety and effectiveness. For investors, receiving approval signals that the drug may soon become available for sale, potentially leading to revenue growth and impacting the company's value.

idiopathic pulmonary fibrosis medical

"chronic cough in patients with idiopathic pulmonary fibrosis (IPF)..."

Idiopathic pulmonary fibrosis is a chronic lung disease in which the air‑carrying tissue becomes progressively thickened and scarred for no identifiable reason, making the lungs stiff and less able to move oxygen—similar to a sponge that hardens and loses its pores. It matters to investors because it is life‑limiting with limited effective treatments, so clinical trial outcomes, regulatory approvals, pricing and reimbursement decisions can strongly affect the commercial value of therapies and the financial prospects of companies developing treatments.

interstitial lung disease medical

"non-IPF interstitial lung disease (non-IPF ILD)..."

A group of lung conditions that cause inflammation and scarring of the thin tissue between the air sacs, which makes it harder for oxygen to pass into the blood; imagine the lungs’ fine filters becoming stiff and less effective. Investors care because reports of interstitial lung disease can affect a drug’s safety profile, trigger regulatory warnings or label changes, and shift demand for treatments or create liability risks that influence a company’s valuation.

refractory chronic cough medical

"the treatment of chronic cough in patients with IPF... and refractory chronic cough (RCC)"

A refractory chronic cough is a long-lasting cough that persists despite standard medical evaluation and treatment, typically lasting eight weeks or more and not improving with usual therapies. Investors should care because it represents a clear unmet medical need that can drive demand for new drugs, devices, or diagnostics—similar to a stubborn problem customers keep returning to a store for until a better solution appears—affecting market potential and regulatory attention.

phase 2b medical

"We have also been preparing to initiate a Phase 2b trial in RCC..."

Phase 2b is a stage in the development of a new medicine or treatment where researchers test its effectiveness and safety in a larger group of people. This step helps determine whether the treatment works well enough to move forward and if it has manageable side effects, which is important for investors because successful results can lead to potential approval and market opportunity.

phase 3 medical

"expects to initiate its Phase 3 program of nalbuphine ER..."

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

oral nalbuphine er medical

"developing the investigational therapy Haduvio™ (oral nalbuphine ER)..."

An oral nalbuphine ER is a slow‑release pill form of nalbuphine, an opioid pain medicine that activates some pain‑blocking pathways while dampening others, which can lower certain side effects and abuse risk compared with traditional opioids. For investors, it signals a product with potential market demand for longer‑lasting, outpatient pain control, but its commercial value depends on clinical benefits, regulatory approval, patent protection and how payers and prescribers view its safety and cost — like a timed-release version of a familiar pain drug.

AI-generated analysis. Not financial advice.

FDA End-of-Phase 2 meeting scheduled to take place in the first quarter of 2026 for the chronic cough program in patients with idiopathic pulmonary fibrosis

Phase 2b refractory chronic cough trial planned to initiate in the first half of 2026

NEW HAVEN, Conn., Jan. 8, 2026 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC), today announced strategic updates ahead of its participation in the 15th Annual LifeSci Partners Corporate Access Event taking place in San Francisco, CA, from January 12-14, 2026. This event will be held during the week of the annual J.P. Morgan Healthcare Conference.

"We are excited as we begin 2026 to continue the clinical development of Haduvio in our key chronic cough indications," said Jennifer Good, President and CEO of Trevi Therapeutics. "We have an End-of-Phase 2 meeting scheduled with the FDA, and we hope to align on our development program for the treatment of chronic cough in patients with IPF and then initiate that program. We have also been preparing to initiate a Phase 2b trial in RCC in the first half of this year. We expect that 2026 will be a year of focused execution at Trevi as we work to advance Haduvio a step closer to patients suffering from these debilitating chronic cough conditions."

Key Company Highlights

• Chronic Cough in IPF
  • The Company was granted an End-of-Phase 2 meeting by the FDA, scheduled to take place in the first quarter of 2026. This meeting will discuss the clinical development and regulatory pathway for the New Drug Application of nalbuphine ER for the treatment of chronic cough in patients with IPF. Following this meeting, the Company expects to initiate its Phase 3 program of nalbuphine ER in this patient population in the first half of 2026.
• Refractory Chronic Cough
  • The Company plans to initiate a Phase 2b trial in patients with RCC in the first half of 2026.
• David Hastings, the new Chief Financial Officer for Trevi Therapeutics, will attend the LifeSci Partners Corporate Access Event along with other members of the senior management team.

About Trevi Therapeutics, Inc.    
Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine extended-release) for the treatment of chronic cough in patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC). Haduvio is the first and only investigational therapy to show a statistically-significant reduction in cough frequency in clinical trials across both patients with IPF chronic cough and in patients with RCC. Haduvio acts on the cough reflex arc both centrally and peripherally as a kappa agonist and a mu antagonist (KAMA), targeting opioid receptors that play a key role in controlling chronic cough. Nalbuphine is not currently scheduled by the U.S. Drug Enforcement Agency.

Chronic cough in patients with IPF and non-IPF ILD is a condition with high unmet need and no FDA-approved therapies. There are ~150,000 U.S. patients with IPF, and two-thirds of these patients are faced with uncontrolled chronic cough. Additionally, there are ~228,000 U.S. patients with non-IPF ILD, with 50-60% having uncontrolled chronic cough. The impact of chronic cough is significant, with patients coughing up to 1,500 times per day. This consistent cough, and any associated damage, may lead to a higher risk of morbidity and mortality, including worsening disease, a higher risk of progression, increased respiratory hospitalizations, and a decline in patients' quality of life.   

RCC is a condition with high unmet need and no FDA-approved therapies. RCC is defined as a persistent cough lasting >8 weeks despite treatment for an underlying condition (i.e., asthma, gastroesophageal reflux disease, non-asthmatic eosinophilic bronchitis, upper airway cough syndrome, or post-nasal drip) and includes unexplained chronic cough. There are ~2-3 million U.S. patients with RCC, and it is believed to be associated with cough reflex hypersensitivity involving both the central and peripheral nervous systems. RCC is highly debilitating and may impact patients physically, psychologically, and socially.  

Trevi intends to propose Haduvio as the trade name for oral nalbuphine ER. Its safety and efficacy have not been evaluated by any regulatory authority. 

For more information, visit www.TreviTherapeutics.com and follow Trevi on X (formerly Twitter) and LinkedIn. 

Forward-Looking Statements   
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements are subject to risks and uncertainties and actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding Trevi's business plans and objectives, including future plans or expectations for Haduvio and plans and timing with respect to clinical trials, expectations regarding Trevi's sufficiency of capital, and other statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions. Risks that contribute to the uncertain nature of the forward-looking statements include: uncertainties regarding the success, cost and timing of Trevi's product candidate development activities and clinical trials; the risk that positive data from a clinical trial may not necessarily be predictive of the results of later clinical trials in the same or a different indication; uncertainties regarding Trevi's ability to execute on its strategy; uncertainties with respect to regulatory authorities' views as to the data from Trevi's clinical trials and next steps in the development path for Haduvio in the United States and foreign countries; uncertainties inherent in estimating Trevi's cash runway, future expenses and other financial results, including Trevi's ability to fund future operations, including clinical trials;  as well as other risks and uncertainties set forth in the quarterly report on Form 10-Q for the quarter ended September 30, 2025 filed with the Securities and Exchange Commission and in subsequent filings made by the Company with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Trevi undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. 

Investor Contact 
Jonathan Carlson 
Trevi Therapeutics, Inc. 
(203) 654 3286 
carlsonj@trevitherapeutics.com  

Media Contact 
Rosalia Scampoli 
914-815-1465 
rscampoli@marketcompr.com  

 

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SOURCE Trevi Therapeutics, Inc.

FAQ

When is Trevi Therapeutics' FDA End-of-Phase 2 meeting for Haduvio (TRVI)?

The company scheduled the End-of-Phase 2 meeting with the FDA in Q1 2026.

Will Trevi (TRVI) start a Phase 3 trial for Haduvio in IPF in 2026?

Trevi expects to initiate a Phase 3 program in IPF in H1 2026, pending FDA alignment.

When will Trevi (TRVI) begin the Phase 2b trial in refractory chronic cough?

The company plans to initiate the Phase 2b RCC trial in the first half of 2026.

What investor events will Trevi (TRVI) management attend in January 2026?

Management, including new CFO David Hastings, will attend the LifeSci Partners event Jan 12-14, 2026.

Does the Jan 8, 2026 update include Haduvio clinical results for TRVI?

No; the update announces regulatory and trial plans but does not provide clinical readouts.

What could delay Trevi's (TRVI) planned Phase 3 start for Haduvio?

Delays could arise if the FDA End-of-Phase 2 meeting does not yield alignment on the development pathway.