Welcome to our dedicated page for Trevi Therapeutics news (Ticker: TRVI), a resource for investors and traders seeking the latest updates and insights on Trevi Therapeutics stock.
Trevi Therapeutics, Inc. reports news on its clinical-stage biopharmaceutical development of Haduvio, an oral extended-release formulation of nalbuphine, for chronic cough in patients with idiopathic pulmonary fibrosis, non-IPF interstitial lung disease, and refractory chronic cough. Company updates commonly cover clinical trial results and plans, FDA interactions, medical-conference presentations, intellectual property, and the investigational status of Haduvio.
Trevi also reports financing and corporate updates tied to its development strategy, including common stock offerings, quarterly financial results, cash runway commentary, and participation in healthcare investor events.
Trevi Therapeutics (NASDAQ: TRVI) provided key updates on its clinical trials and financial position. The company completed patient visits for its Phase 2a RIVER trial in refractory chronic cough (RCC), with topline results expected in Q1 2025. The Phase 2b CORAL trial in idiopathic pulmonary fibrosis (IPF) patients with chronic cough is approximately 80% enrolled, with results anticipated in H1 2025.
The company recently announced positive outcomes from both the sample size re-estimation analysis of the Phase 2b CORAL trial and their Human Abuse Potential study. Trevi's preliminary estimate indicates cash, cash equivalents, and marketable securities of $107.6 million as of December 31, 2024, providing runway into H2 2026.
Trevi Therapeutics (TRVI) has announced the pricing of an underwritten offering of 12,500,000 shares of common stock at $4.00 per share, aiming to raise $50 million before deducting underwriting costs. The offering, expected to close on December 17, 2024, includes participation from notable investors such as Adage Capital Partners LP, Frazier Life Sciences, and Vivo Capital.
The company, which is developing Haduvio™ (oral nalbuphine ER) for chronic cough treatment in idiopathic pulmonary fibrosis and refractory chronic cough, is conducting the offering through a shelf registration statement previously filed with the SEC. Leerink Partners, Stifel, and Oppenheimer & Co. are serving as joint book-running managers.
Trevi Therapeutics (NASDAQ: TRVI) announced positive results from its planned sample size re-estimation (SSRE) for the Phase 2b CORAL trial, confirming no changes needed to the current sample size of 160 patients. The trial, testing Haduvio™ for chronic cough in idiopathic pulmonary fibrosis (IPF) patients, has reached 75% enrollment, with topline results expected in H1 2025.
The SSRE analysis, conducted on the highest dose (108mg twice daily) after 80 patients completed treatment, supported maintaining the pre-specified conditional power of 80% or greater. The CORAL trial is evaluating three doses of Haduvio (27mg, 54mg, and 108mg twice daily) against placebo in IPF patients with chronic cough, with the primary endpoint measuring relative change in 24-hour cough frequency.
Trevi Therapeutics (NASDAQ: TRVI) announced positive results from their human abuse potential (HAP) study of oral nalbuphine. The study demonstrated statistically significant lower 'Drug Liking' for clinical doses (81mg and 162mg) compared to 6mg IV butorphanol. The primary endpoint measured peak effect for 'Drug Liking' on a 100-point visual analog scale.
Key findings showed mean Emax 'Drug Liking' scores of 71.2 and 74.5 for 81mg and 162mg oral nalbuphine respectively, compared to 82.3 for butorphanol (p0.0001 and p=0.0008). Secondary endpoints were consistent with primary findings. The supratherapeutic dose (486mg) showed numerically lower but not statistically significant results. No serious adverse events were reported.
Trevi Therapeutics (Nasdaq: TRVI) announced its participation in the Piper Sandler 36th Annual Healthcare Conference, scheduled for December 3-5 in New York. Jennifer Good, President and CEO, will deliver a corporate presentation on December 4, 2024, at 1:00 p.m. ET. The company, which is developing Haduvio™ (oral nalbuphine ER) for chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), will also have its CEO and CFO participate in investor meetings during the event. The presentation and meetings will be accessible to in-person attendees.
Trevi Therapeutics (Nasdaq: TRVI) announced its third quarter 2024 financial results and business updates.
The company completed enrollment in the Phase 2a RIVER trial for refractory chronic cough (RCC), with topline results expected in Q1 2025. It also reached 50% enrollment in the Phase 2b CORAL trial for chronic cough in idiopathic pulmonary fibrosis (IPF), with sample size re-estimation results due in December 2024.
Trevi ended Q3 2024 with $65.5 million in cash and equivalents, projecting a cash runway into the second half of 2026.
R&D expenses rose to $11.2 million from $6.3 million year-over-year, driven by increased clinical development costs. G&A expenses increased slightly to $2.9 million. The company reported a net loss of $13.2 million, compared to $7.7 million in Q3 2023.
Topline results from the Human Abuse Potential (HAP) study are expected in December 2024.
Trevi Therapeutics (NASDAQ: TRVI) has announced it will report its Q3 2024 financial results and provide a corporate update on November 6, 2024, at 4:30 p.m. ET. The company, which is developing Haduvio™ (oral nalbuphine ER) for chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), will host a conference call and webcast. Participants can join via phone at (877) 870 4263 (domestic) or (412) 317 0790 (international). The webcast will be available on the company's website and archived for 30 days.
Trevi Therapeutics (Nasdaq: TRVI) has completed enrollment for its Phase 2a RIVER trial, evaluating Haduvio™ (oral nalbuphine ER) for refractory chronic cough (RCC). The company expects to report topline results in Q1 2025. The trial is a randomized, double-blind, placebo-controlled study conducted in the UK and Canada, designed to assess the efficacy, safety, and tolerability of Haduvio in RCC patients.
The primary endpoint is the mean change in 24-hour cough frequency, measured by an objective cough monitor. The study includes two subgroups based on cough frequency: moderate (10-19 coughs/hour) and high (≥20 coughs/hour). Secondary endpoints include patient-reported outcome measures for cough frequency and severity. Approximately 60 adult patients were enrolled in the trial.
Trevi Therapeutics, a clinical-stage biopharmaceutical company developing Haduvio™ for chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), announced its participation in upcoming commercial and investor conferences. The company's senior management will attend three events:
1. 3rd Chief Commercial Officer Summit in Philadelphia, PA (October 23-24, 2024), where Farrell Simon will present on Commercial's Role in Clinical Trial Recruitment.
2. BIO-Europe in Stockholm, Sweden (November 4-6, 2024), with Farrell Simon representing Trevi.
3. Stifel 2024 Healthcare Conference in New York, NY (November 18-19, 2024), featuring a corporate presentation by Jennifer Good and Lisa Delfini.
These events provide opportunities for Trevi to showcase its progress in developing Haduvio™ and engage with industry professionals and investors.
Trevi Therapeutics (Nasdaq: TRVI) has provided updates on its clinical development programs for Haduvio™ (oral nalbuphine ER), an investigational therapy for chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC). The Phase 2b CORAL trial for IPF chronic cough has reached 50% enrollment, with sample size re-estimation results expected in December 2024. The Human Abuse Potential (HAP) study has completed dosing, with topline results expected in December 2024. The Phase 2a RIVER trial for RCC has enrolled the planned sample size but remains open for additional enrollment, with topline results now expected in Q1 2025. Trevi's CEO, Jennifer Good, expressed excitement about these milestones, highlighting the potential of Haduvio's unique mechanism to address the unmet need in IPF chronic cough.