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Trevi Therapeutics, Inc. (Nasdaq: TRVI) is a late-stage biopharmaceutical company devoted to addressing chronic pruritic conditions and chronic cough through its investigational therapy, Haduvio™ (oral nalbuphine ER). Haduvio is an oral extended-release formulation of nalbuphine, a synthetic opioid with a dual mechanism of action: as a ĸ-opioid receptor agonist and µ-opioid receptor antagonist. This unique mechanism has shown promise in clinical trials for reducing symptoms associated with chronic cough, particularly in idiopathic pulmonary fibrosis (IPF), refractory chronic cough (RCC), and prurigo nodularis, a dermatologic condition characterized by pruriginous lesions.
Trevi is advancing various pruritic conditions through clinical development, including prurigo nodularis, which currently has no approved therapies in the US or EU. The company's lead indication involves extensive studies and trials, such as the recent Phase 2b/3 PRISM (Pruritus Relief through Itch-Scratch Modulation) trial, which demonstrated Haduvio's efficacy and safety over 52 weeks.
In the chronic cough segment, Trevi's Haduvio is undergoing trials like the Phase 2a RIVER study for RCC and the Phase 2b CORAL trial for chronic cough in IPF. The RIVER trial is a double-blind, placebo-controlled study evaluating Haduvio's impact on 24-hour cough frequency, while the CORAL trial investigates three dose levels of Haduvio against a placebo in IPF patients, assessing endpoints like cough frequency reduction and quality of life improvements.
Trevi's innovative approach aims to provide relief where current treatments fail, supported by promising clinical data and ongoing trials. The company's commitment to addressing unmet medical needs is reflected in its thorough and transparent communication with investors and stakeholders, ensuring that all developments are promptly shared, including financial results and future plans.
For more detailed information on Trevi Therapeutics, its clinical trials, and its forward-looking statements, visit TreviTherapeutics.com and follow the company on Twitter and LinkedIn.
Trevi Therapeutics has announced a public offering of its common stock and pre-funded warrants to purchase common stock. The offering, managed by SVB Securities, Stifel, and Oppenheimer & Co., is subject to market conditions, with a 30-day option for underwriters to purchase additional shares. The offering is made under a shelf registration statement filed with the SEC, and preliminary terms will be detailed in a forthcoming prospectus supplement. Trevi focuses on developing Haduvio, an investigational therapy for chronic cough and prurigo nodularis.
Trevi Therapeutics (Nasdaq: TRVI) announced positive results from its Phase 2 CANAL trial of Haduvio, an investigational therapy for chronic cough in patients with idiopathic pulmonary fibrosis. The trial showed a significant reduction in daytime cough frequency, with a 75.1% decrease compared to 22.6% for placebo (p<0.0001). Secondary endpoints also demonstrated consistent efficacy across patient-reported outcomes. The results were consistent with the interim analysis, and the company plans to initiate the next clinical trial in early 2023, as there are no approved therapies for chronic cough in IPF patients.
Trevi Therapeutics, a clinical-stage biopharmaceutical company, announced that its CEO, Jennifer Good, will present at the H.C. Wainwright 24th Annual Global Investment Conference on September 12, 2022, at 10:30 AM ET. The presentation will highlight the investigational therapy Haduvio™ (oral nalbuphine ER), aimed at treating prurigo nodularis and chronic cough in adults with idiopathic pulmonary fibrosis. Trevi is focused on the development of Haduvio, which has received Fast Track designation from the FDA.
Trevi Therapeutics, Inc. (Nasdaq: TRVI) announced a virtual R&D Day scheduled for September 19, 2022, from 10 AM to 12:30 PM ET. The event will feature expert presentations from Dr. Peter Dicpinigaitis and Dr. Brian Kim, focusing on chronic cough and prurigo nodularis. Trevi will provide updates on its investigational therapy Haduvio (oral nalbuphine ER), which aims to address unmet needs in these conditions. Participants can register and access a live webcast of the event.
Trevi Therapeutics, Inc. (TRVI) announced that two late-breaking abstracts have been accepted for oral presentations at upcoming medical conferences. The European Respiratory Society International Congress 2022, held in Barcelona from September 4-6, will feature data from the Phase 2 CANAL trial on the use of Haduvio™ (oral nalbuphine ER) for chronic cough in idiopathic pulmonary fibrosis (IPF). Similarly, the EADV Congress in Milan from September 7-10 will present findings from the Phase 2b/3 PRISM trial on prurigo nodularis. Both trials reported statistically significant efficacy results.
Trevi Therapeutics reported positive results from the Phase 2b/3 PRISM trial of its investigational therapy, Haduvio™, for treating Prurigo Nodularis. The trial achieved its primary endpoint, with 25% of Haduvio patients showing a significant reduction in itch compared to 14% on placebo (p=0.0157). The company completed a $55 million private placement to support further clinical development. For Q2 2022, Trevi's total cash was $78.9 million, with a net loss of $8.1 million, improved from $9.8 million in Q2 2021.
Future data from the Phase 2 CANAL trial on chronic cough is expected later this quarter.
Trevi Therapeutics, Inc. (NASDAQ: TRVI) announced its participation in two key conferences in August 2022. On August 16, CEO Jennifer Good will engage in a fireside chat at the Stifel Biotech Executive Summer Summit. On August 29, CMO Thomas Sciascia and Professor Toby Maher will co-host a workshop at the 6th Annual IPF Summit in Boston, emphasizing chronic cough treatment strategies. Trevi's investigational therapy Haduvio is being developed for prurigo nodularis and chronic cough in adults with idiopathic pulmonary fibrosis, with FDA Fast Track designation for itch treatment.
Trevi Therapeutics (Nasdaq: TRVI) will host a conference call and live audio webcast on August 11, 2022, at 4:30 p.m. ET, to discuss its Q2 2022 financial results and provide a corporate update. The company is developing Haduvio (oral nalbuphine ER) as a treatment for prurigo nodularis and chronic cough in patients with idiopathic pulmonary fibrosis. Haduvio has received FDA Fast Track designation for the treatment of itch. More information can be accessed on the company’s website.
Trevi Therapeutics (Nasdaq: TRVI), a clinical-stage biopharmaceutical company, will participate in The Twelfth London International Cough Symposium on July 13-14, 2022. The event will focus on advancements related to acute and chronic cough, including novel treatments. Trevi is developing Haduvio (oral nalbuphine ER) aimed at treating prurigo nodularis and chronic cough in idiopathic pulmonary fibrosis patients. Haduvio has received Fast Track designation from the FDA for reducing pruritus in affected adults, though its efficacy is yet to be evaluated by regulatory authorities.
Trevi Therapeutics (TRVI) announced positive results from its Phase 2b/3 PRISM trial evaluating Haduvio for treating prurigo nodularis. The trial achieved statistical significance with a 4-point reduction in the Worst Itch – Numerical Rating Scale (WI-NRS) for 25% of Haduvio patients compared to 14% for placebo (p=0.0157). Key secondary endpoints were also met. The drug's safety profile was consistent with prior studies. Topline results will be discussed in a conference call on June 29, 2022, at 8:30 am EDT, highlighting Haduvio's potential in addressing severe itching and enhancing quality of life.
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