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NEW HAVEN - Trevi Therapeutics, Inc. (NASDAQ: TRVI), a biotech company with a market capitalization of $660 million and strong momentum shown by a 134% surge over the past six months, announced additional analyses from its Phase 2a RIVER trial, evaluating the investigational therapy Haduvio™ for patients with refractory chronic cough (RCC). According to InvestingPro data, five analysts have recently revised their earnings expectations upward for the upcoming period. The results, presented at the American Thoracic Society 2025 International Conference today, build on positive topline findings released in March 2025.
The Phase 2a RIVER trial, a randomized, double-blind, placebo-controlled study, assessed the efficacy, safety, and tolerability of Haduvio in RCC patients. The primary endpoint was a mean change in 24-hour cough frequency at Day 21. Haduvio met the primary endpoint with a significant reduction in cough frequency by 67% from baseline and 57% on a placebo-adjusted basis (p
Further analyses demonstrated statistically significant improvements in cough frequency reduction at various thresholds and in patient-reported outcomes using the Leicester Cough Questionnaire. Adverse events were more common during initial exposure to the drug but lessened over time, despite increased dosing. Discontinuations were mostly due to adverse events in the first two weeks.
RCC, with no approved therapies in the U.S., affects approximately 2-3 million patients and is characterized by cough reflex hypersensitivity. It can lead to complications such as urinary incontinence and social embarrassment, imposing a significant burden on patients’ lives.
James Cassella, Ph.D., Chief Development Officer at Trevi, expressed optimism about the magnitude and consistency of Haduvio’s effect and mentioned the anticipation of results from a Phase 2b trial in IPF patients with chronic cough, which will inform the future development path for both indications.
Haduvio, which acts both centrally and peripherally, is the first investigational therapy to show a significant reduction in cough frequency in clinical trials for IPF chronic cough and RCC patients. Its safety and efficacy have yet to be evaluated by regulatory authorities. InvestingPro analysis reveals that while the company maintains strong liquidity with a current ratio of 15.38 and holds more cash than debt, it’s not yet profitable. For deeper insights into Trevi’s financial health and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers.
Trevi Therapeutics, focused on developing Haduvio for chronic cough conditions, is yet to receive regulatory approval for the drug. The additional analyses from the RIVER trial contribute to the body of evidence supporting its potential as a treatment for RCC. This information is based on a press release statement.
In other recent news, Trevi Therapeutics reported a better-than-expected earnings performance for the first quarter of 2025. The company posted an earnings per share (EPS) loss of $0.09, surpassing analyst expectations of a $0.13 loss. This reflects improved operational efficiency and cost management. Trevi’s net loss was $10.4 million, a decrease from $10.9 million in the same quarter the previous year, with research and development expenses reduced to $7.8 million.
Additionally, Raymond James maintained a Strong Buy rating on Trevi Therapeutics with a price target of $29.00, citing positive data from the company’s Phase 2a RIVER study on Haduvio for Refractory Chronic Cough (RCC). The data suggests significant efficacy, reinforcing confidence in Haduvio’s potential for expanded therapeutic use. The company is also progressing with its Phase 2b CORAL trial for IPF chronic cough patients, with top-line data expected soon. These developments indicate Trevi’s ongoing efforts to advance its treatment options in cough-related conditions.
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