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On Wednesday, H.C. Wainwright reaffirmed a Buy rating and a $12.50 price target on Trevi Therapeutics (NASDAQ:TRVI) shares. The stock has shown remarkable momentum, delivering an 89.6% return over the past year and 59.2% year-to-date. According to InvestingPro data, analyst targets for TRVI range from $11 to $29, reflecting strong institutional confidence in the company’s potential. The firm’s optimism is rooted in the promising results from the recent Haduvio (oral nalbuphine ER) RIVER Phase 2a study for refractory chronic cough (RCC). Analysts at H.C. Wainwright highlighted the drug’s consistent efficacy demonstrated in previous trials, which they believe has reduced the risk for the upcoming CORAL Phase 2b study results.
Trevi Therapeutics recently announced its fourth-quarter earnings and confirmed the expected release of topline data from the CORAL Phase 2b trial in patients with idiopathic pulmonary fibrosis who have chronic cough (IPF-CC) for the second quarter of 2025. The CORAL study is the first parallel-arm study of Haduvio, as opposed to earlier crossover studies, and it is more extensive, with numerous global sites participating.
Analysts emphasized the significance of the December CORAL sample size re-estimation (SSRE) analysis. The analysis, based on an unblinded look at 50% completion, recommended no study up-sizing. InvestingPro analysis shows the company maintains strong financial health with a current ratio of 10.41, indicating robust liquidity to support its ongoing clinical trials. The company’s next earnings report is scheduled for May 8, 2025, which could provide further insights into the trial’s progress. This decision suggests confidence in the trial’s design and the potential of Haduvio. The CORAL study is powered to detect a smaller 36% effect size than the results seen in prior studies, even with a high discontinuation rate of around 30% factored in. However, actual discontinuation rates have been much lower, in the single digits.
H.C. Wainwright’s report also notes that the CORAL study will help determine the appropriate dose of Haduvio, potentially confirming the impressive efficacy at the lowest 27mg BID dose observed in the RIVER study. Positive outcomes, along with corroborating patient-reported results, could significantly strengthen Haduvio’s benefit-risk profile. Additionally, data from an ongoing Phase 1 respiratory study in sleep-disordered IPF patients and results from the Human Abuse Potential study, which showed higher 162mg oral nalbuphine had less "drug liking" than butorphanol, a Schedule IV drug, are expected to support Trevi’s position in discussions with the FDA for Phase 3 trial design.
The analysts concluded that the forthcoming CORAL topline data bolster their optimistic view of Haduvio as a leading anti-tussive treatment for refractory cough conditions. They project Haduvio to launch for IPF-CC in 2029 and RCC in 2023, with combined peak sales anticipated to reach $1.7 billion. The $12.50 price target remains in place, taking into account the risks associated with drug development. With a current market capitalization of $586 million, InvestingPro research indicates the stock is trading near its Fair Value. Investors seeking deeper insights can access the comprehensive Pro Research Report, which provides detailed analysis of TRVI’s financial health, market position, and growth potential among 1,400+ top US stocks.
In other recent news, Trevi Therapeutics reported a net loss of $11.4 million for the fourth quarter of 2024, an increase from $7.8 million in the same period of 2023. The company’s earnings per share (EPS) of -0.11 slightly surpassed the forecast of -0.12. This comes amid Trevi’s significant investments in research and development, which rose to $9.3 million, primarily due to ongoing clinical trials. The company maintains a strong cash position with $107.6 million in cash and equivalents, supported by a $50 million offering completed in December.
Trevi is advancing its HEDUVIO treatment for chronic cough, with promising results in recent trials. The company plans to present further data at upcoming conferences and is preparing for discussions with the FDA. Analysts have not indicated any upgrades or downgrades following these announcements. The company expects its cash burn to be between $12 million and $14 million per quarter in the first half of 2025. Trevi’s management has confirmed that their cash runway guidance remains secure into the second half of 2026.
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