Trevi Therapeutics 14.25M share Spot Secondary priced at $1.93 » 07:0709/2309/23/22
SVB Securities, Stifel…
SVB Securities, Stifel and Oppenheimer acted as joint book running managers for the offering.
|Over a week ago|
Fly Intel: After-Hours Movers » 17:5409/2209/22/22
FLUX, CAMP, DLNG, GWRE, RSSS, COST, EDAP, TRVI, APEI
Check out this evening's…
Trevi Therapeutics files to sell common stock, no amount given » 16:0209/2209/22/22
SVB Securities, Stifel…
SVB Securities, Stifel and Oppenheimer & Co. are acting as joint bookrunning managers for the offering. Needham & Company is acting as lead manager for the offering.
Three new option listings and one option delisting on September 19th » 08:3009/1909/19/22
RUM, TRVI, CTT
New option listings for…
New option listings for September 19th include RUM Stock (RUM), SNPTY Stock (SNPTY), and Trevi Therapeutics Inc (TRVI). Option delistings effective September 19th include Catchmark Timber Trust Inc (CTT).
Trevi Therapeutics announces data from its Phase 2 CANAL trial of Haduvio » 07:3609/1909/19/22
Trevi Therapeutics announced positive results from the full set of subjects in its Phase 2 Cough And NALbuphine, CANAL, trial of Haduvio for the treatment of chronic cough in IPF. Dr. William Forbes will present the data during the Company's Virtual R&D Day today. Following the statistically significant efficacy results from the CANAL trial's interim analysis conducted in February 2022, the Company concluded enrollment early in March 2022 and allowed enrolled subjects to complete the trial. Topline data from the full set of subjects in the Phase 2 CANAL trial was statistically significant for the trial's primary endpoint and showed a 52.5% change compared to placebo, with a 75.1% reduction in the geometric mean percent change in daytime cough frequency for Haduvio. "We are pleased to announce the positive results from the full set of subjects from the CANAL trial, which are consistent with the previously announced interim analysis and further demonstrated that Haduvio has the potential to reduce IPF patients' cough," said Jennifer Good, President and CEO of Trevi Therapeutics. "We analyzed the change of 24hr cough frequency as well as daytime cough frequency and observed consistent reductions for both measurements. There are no approved therapies for chronic cough in these patients, and we are excited to continue our development in this indication and look forward to starting our next clinical trial for these patients in the first half of 2023. We would like to thank the CANAL trial participants and investigators for their contribution to this research as we look to improve IPF patients' quality of life." Additional Efficacy Analyses: Haduvio subjects had a 76.1% reduction in 24hr cough frequency compared to a 25.3% of placebo subjects, a 50.8% placebo-adjusted change. In a post-hoc analysis, 97% of Haduvio subjects had at least a 30% reduction in 24hr cough frequency compared to 35% of placebo subjects, signifying a clinically meaningful reduction in cough. Subjects on Haduvio experienced a statistically significant improvement as measured by their patient reported outcomes compared to placebo over the 3-week treatment period in the EXACT2: Cough Frequency Score and Cough Severity Numerical Rating Scale. Based on the Clinical Global Impression of Change rating measuring clinicians' view of change since the start of the trial, 62% of Haduvio subjects improved vs. baseline compared to 19% of placebo subjects. Safety and Tolerability Results: The safety results of the trial were generally consistent with the known safety profile of Haduvio from previous trials.
|Over a quarter ago|
Trevi Therapeutics price target raised to $10 from $8 at Needham » 16:2006/2906/29/22
Needham analyst Serge…
Needham analyst Serge Belanger raised the firm's price target on Trevi Therapeutics to $10 from $8 and keeps a Buy rating on the shares. The stock closed Wednesday up 21% to $2.45. The Phase 2b/3 trial evaluating Haduvio as a treatment for prurigo nodularis successfully met the key primary and secondary endpoints, Belanger tells investors in a research note. The analyst says Haduvio had a quick onset of action reaching statistical significance at six-weeks with efficacy that had yet to plateau at the week-14 readout. Belanger believes Trevi's valuation discounts Haduvio's potential and upped the price target to reflect "additional de-risking" of the prurigo nodularis program.
Trevi Therapeutics' Haduvio meets efficacy endpoint in Phase 2b/3 trial » 07:4006/2906/29/22
Trevi Therapeutics announced positive results from its Phase 2b/3 PRISM trial of Haduvio in treating prurigo nodularis. Prurigo nodularis is a chronic disease characterized by severe pruritus and the presence of nodules, lesions, and excoriations. Chronic pruritus is a key contributing cause of prurigo nodularis and manifests in an itch-scratch cycle, which is difficult to disrupt. There are no approved therapies for prurigo nodularis. In the Phase 2b/3 trial, results comparing subjects randomized to Haduvio monotherapy or placebo showed: 25% of Haduvio subjects evaluated at week 14 met the primary endpoint of a 4-point reduction in WI-NRS from baseline compared to 14% of placebo subjects; Haduvio subjects experienced significantly greater improvements in ItchyQoL vs. placebo at week 14, which was statistically significant across each of the three domains. ItchyQoL is used to measure how pruritus impacts a subject's quality-of-life. 55% of Haduvio subjects saw at least a 1-category improvement in the 5-point scale in their Prurigo Activity Scale (pruriginous lesions with excoriations), vs. 38% on placebo (p=0.006) as evaluated at week 14. The safety results of the trial were generally consistent with the known safety profile of Haduvio from previous trials. None of the SAEs were considered by the investigator to be treatment-related. Adverse events most commonly observed with Haduvio were nausea, dizziness, headache, and constipation.
Trevi Therapeutics initiated with an Outperform at Oppenheimer » 16:0405/2405/24/22
Oppenheimer analyst Leland Gershell initiated coverage of Trevi Therapeutics with an Outperform rating and $10 price target, citing the prospects of oral candidate Haduvio to address chronic cough associated with idiopathic pulmonary fibrosis. He also expresses "enthusiasm" for its prospects to treat severe chronic itch and forecasts total peak sales of $750M-plus for Haduvio, Gershell tells investors.
Trevi Therapeutics reports Q1 EPS (24c), consensus (29c) » 16:1205/1205/12/22
As of March 31, 2022, the…
As of March 31, 2022, the company had total cash and cash equivalents of $29.1M. "We are delighted with the significant progress made this year in achieving Trevi's clinical development goals and the advancement of Haduvio," said CEO Jennifer Good. "The interim analysis results of the Phase 2 CANAL study allowed us to end enrollment early in the trial and begin preparations to accelerate development for this indication. Additionally, the successful closing of a $55M private placement on April 11, 2022, allows us to fund the next phase of development for Haduvio in chronic cough in IPF. We look forward to our expected data readout for the Phase 2b/3 PRISM study this quarter and the data readout from the full set of subjects for the Phase 2 CANAL study in the third quarter of this year."
Trevi Therapeutics files to sell 28.96M shares of common stock for holders 16:1905/0205/02/22