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Trevi Therapeutics, Inc. (NASDAQ:TRVI), a biotech company with a market capitalization of $743 million and an impressive 153% return over the past year, announced on Monday positive topline results from its Phase 2b CORAL clinical trial evaluating Haduvio (oral nalbuphine ER) for treating chronic cough in patients with idiopathic pulmonary fibrosis (IPF). According to InvestingPro analysis, the stock appears overvalued at current levels, though analysts maintain price targets ranging from $11 to $29. The company, based in New Haven, Connecticut, reported that the trial met its primary endpoint, demonstrating statistically significant reductions in 24-hour cough frequency across all dose groups at Week 6.
The trial revealed that patients receiving 108 mg BID, 54 mg BID, and 27 mg BID doses of Haduvio experienced reductions in cough frequency by 60.2% (p
Trevi Therapeutics also observed a rapid reduction in cough frequency by Week 2, the first time point measured. By Week 6, 65% of patients in the 108 mg BID group, 63% in the 54 mg BID group, and 60% in the 27 mg BID group achieved a 50% reduction in cough frequency, compared to 19% in the placebo group.
The study indicated a statistically significant response on the cough-severity numerical rating scale (CS-NRS) for the 108 mg BID and 54 mg BID groups, with mean reductions of 3.0 and 3.2 points, respectively. The placebo group saw a 1.5-point reduction. The 108 mg BID and 54 mg BID groups also showed significant results on the E-RS: IPF Cough Subscale, with mean relative changes from baseline of -42.4% and -43.1%, respectively, compared to -23% for placebo.
The safety profile of Haduvio was consistent with previous trials, with similar discontinuation rates due to adverse events between the Haduvio (5.6%) and placebo (5.0%) groups. Common adverse events included nausea, vomiting, and dizziness, among others. Serious non-fatal adverse events were reported in four placebo patients and two in the Haduvio groups.
Trevi Therapeutics plans to request an end of Phase 2 meeting with the U.S. Food and Drug Administration in the second half of 2025 to discuss a Phase 3 program for Haduvio. The company also intends to initiate a clinical trial for chronic cough in non-IPF interstitial lung disease patients and a Phase 2b trial for refractory chronic cough in 2026. This information is based on a press release statement. With five analysts recently revising their earnings estimates upward and the stock showing lower volatility than the market with a beta of 0.62, investors can access comprehensive analysis and 10+ additional ProTips through InvestingPro’s detailed research reports.
In other recent news, Trevi Therapeutics announced positive results from its Phase 2b CORAL trial for the investigational therapy Haduvio, targeting chronic cough in patients with idiopathic pulmonary fibrosis (IPF). The trial successfully met its primary endpoint, demonstrating significant reductions in cough frequency across all tested doses. Analysts at H.C. Wainwright and B.Riley have shown optimism regarding Trevi’s prospects, with both firms maintaining Buy ratings and setting price targets of $21 and $20, respectively. H.C. Wainwright noted the strong potential for Haduvio to generate substantial revenue, estimating over $1 billion in the refractory chronic cough (RCC) market alone. Meanwhile, B.Riley highlighted the efficacy data from the Phase 2a RIVER trial, which underscored Haduvio’s impact on chronic cough conditions. Stifel also maintained a Buy rating with a $15 price target, emphasizing the unique mechanism of action of Haduvio and the promising results from the RIVER trial. Trevi plans to discuss these trial outcomes further in a conference call and aims to engage with the FDA to initiate a Phase 3 program. The company remains focused on advancing Haduvio as a potential treatment for chronic cough conditions, with ongoing anticipation for future data releases.
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