Topline results are expected in the first quarter of 2025NEW HAVEN, Conn., Oct. 21, 2024 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced that it has completed enrollment in its Phase 2a trial for the treatment of RCC ("RIVER") and expects to report topline data in ...

NEW HAVEN, Conn., Oct. 15, 2024 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced that senior management will be attending the following investor and medical conferences in October and November. 3rd Chief Commercial Officer Summit October 23-24, 2024, Philadelphia, P ...

NEW HAVEN, Conn., Sept. 30, 2024 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinicalstage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced the appointment of James V. Cassella, Ph.D., as Chief Development Officer (CDO). "I am delighted to welcome Jim, who has been a member of our Board of Directors for the past four years, ...

Professor Alyn Morice will present an analysis of cough relief in patients with idiopathic pulmonary fibrosis who were treated with nalbuphine ER NEW HAVEN, Conn., Sept. 26, 2024 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinicalstage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced that data from the Phase 2a CANAL trial ...

Publicly traded biopharmaceutical firms can have large, sometimes triple-bagger, expectations placed on them by Wall Street analysts. This is especially true for companies like Trevi Therapeutics NASDAQ: TRVI, which don't yet have any products approved by the Food and Drug Administration (FDA). This means these firms may have little or no revenue, as is the case for Trevi. Trevi Therapeutics Today TRVI Trevi Therapeutics $3.10 +0.15 (+5.08%) 52-Week Range $0.97 ▼ $4.00 Price Target $7.80 Add to Watchlist A ...

Professor Jacky Smith will present on the correlation between the change in objective cough count and improvement in patient-reported outcomes with nalbuphine ER in IPF patients NEW HAVEN, Conn., Sept. 4, 2024 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced that da ...

NEW HAVEN, Conn., Aug. 28, 2024 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinicalstage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced that senior management will be attending the following investor and medical conferences in September. 2024 Wells Fargo Healthcare Conference September 4-6, 2024, Boston, MA Trevi Represe ...

Financial Data and Key Metrics Changes - For Q2 2024, the company reported a net loss of $12.4 million, compared to a net loss of $7.1 million in Q2 2023 [14] - R&D expenses increased to $10 million in Q2 2024 from $5.8 million in Q2 2023, reflecting strong clinical activity across all trials [14] - G&A expenses rose to $3.3 million in Q2 2024 from $2.5 million in Q2 2023, primarily due to increases in personnel and related expenses [14] - As of June 30, 2024, cash, cash equivalents, and marketable securities totaled $69.5 million, down from $83 million as of December 31, 2023 [14] Business Line Data and Key Metrics Changes - The Phase 2a RIVER trial for refractory chronic cough (RCC) is expected to read out in Q4 2024, with approximately 80% of subjects enrolled [5][7] - The IPF chronic cough trial, CORAL, is a Phase 2b study involving approximately 160 patients, with enrollment progressing well [8][9] - The human abuse potential (HAP) study is 95% enrolled, with data expected in Q4 2024 [10] Market Data and Key Metrics Changes - The company estimates that there are approximately 2 million to 3 million treatable patients in the U.S. for RCC, with about 7 million diagnosed [55] - There is a significant unmet need for therapies in both RCC and IPF chronic cough, with no currently approved treatments for chronic cough in IPF [6][8] Company Strategy and Development Direction - The company is focused on executing clinical development plans for chronic cough and IPF, with a commitment to prioritize IPF as the lead indication [31] - The company aims to optimize the value of Haduvio by potentially positioning it as a third-line therapy behind other treatments in the RCC market [31] - The company is conducting supportive studies to inform the development path for Haduvio in chronic cough conditions [10][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the ongoing clinical trials and the potential for Haduvio to address significant unmet needs in chronic cough conditions [4][6] - The company anticipates steady news flow of data in the upcoming months and plans to participate in several investor conferences [63] Other Important Information - The company issued approximately 1.5 million shares from its ATM during the quarter, strengthening its cash runway post-data readouts [14] - The company expects cash burn to average between $9 million to $12 million per quarter in 2024, with a cash runway extending into 2026 [14] Q&A Session Summary Question: Regarding the RIVER chronic cough trial, were different powering assumptions used for different severity groups? - Management confirmed that the same assumptions were made for the effect size in subgroup analyses [17] Question: Can you confirm the scheduling status of nalbuphine and its implications? - Management indicated that nalbuphine remains unscheduled and expressed confidence that it should remain so based on existing data [18] Question: What are the expectations for enrollment in the respiratory physiology study? - Management stated that the study will start with the same population as the CORAL study and will expand to include sleep-disordered breathing subtypes [24] Question: How does the outcome of the RCC trial impact plans for IPF? - Management emphasized that IPF remains the lead indication, but the outcome of the RCC trial will be considered in future strategies [31] Question: What is the current patent coverage for nalbuphine? - Management detailed that method of treatment patents extend through 2039, with additional applications being prosecuted to extend coverage further [52] Question: How many patients are diagnosed with RCC and seeking treatment? - Management estimated that there are about 2 million to 3 million treatable patients in the U.S. for RCC [55] Question: What is the anticipated delay for the RCC readout due to enrollment imbalance? - Management does not expect any delay and reaffirmed guidance for Q4 2024 for data readout [59]

Topline results expected in the fourth quarter of 2024 in the Phase 2a RIVER trial in refractory chronic cough (RCC) Sample size re-estimation milestone is expected in the fourth quarter of 2024 in the Phase 2b CORAL trial in chronic cough in idiopathic pulmonary fibrosis (IPF) Ended the second quarter of 2024 with $69.5 million in cash, cash equivalents and marketable securities with expected cash runway into 2026 Management to host a conference call and webcast today at 4:30 p.m. ET NEW HAVEN, Conn., Aug. ...

Conference call and webcast to be held at 4:30 p.m. ET NEW HAVEN, Conn., Aug. 1, 2024 /PRNewswire/ -- Trevi Therapeutics, Inc. (Nasdaq: TRVI), a clinical-stage biopharmaceutical company developing the investigational therapy Haduvio™ (oral nalbuphine ER) for the treatment of chronic cough in idiopathic pulmonary fibrosis (IPF) and refractory chronic cough (RCC), today announced that senior management will host a conference call and live audio webcast on Thursday, August 8, 2024, at 4:30 p.m. ET, to provide ...