Core Insights - Biotech shares experienced significant movements in after-hours trading, with Sarepta Therapeutics leading due to anticipated trial data and other companies benefiting from recent clinical and regulatory updates [1] Company Summaries - Sarepta Therapeutics Inc. (SRPT) saw a surge of 9.65% to $23.17, driven by anticipation for a webcast on January 26, 2026, where three-year topline results from its Phase 3 trial of ELEVIDYS for Duchenne muscular dystrophy will be presented, potentially pivotal for its gene therapy program [2] - Fractyl Health, Inc. (GUTS) increased by 7.66% to $2.25, indicating speculative interest despite no new company news, suggesting momentum-driven trading [3] - Greenwich LifeSciences, Inc. (GLSI) advanced 2.08% to $26.00 following FDA approval of the first commercial lot of GP2 vials for the FLAMINGO-01 trial, marking a significant step in its commercialization efforts with the potential to prepare approximately 200,000 doses [4] - Anebulo Pharmaceuticals, Inc. (ANEB) rose 8.41% to $1.16, attracting buyers despite no new updates, reflecting investor interest [5] - OmniAb, Inc. (OABI) gained 4.59% to $2.05, similar to Anebulo, indicating broader investor interest in the biotech sector without fresh news [6] - Trevi Therapeutics, Inc. (TRVI) added 3.40% to $10.33 after publishing results from its Phase 2b CORAL trial in a peer-reviewed journal, enhancing credibility and investor enthusiasm [7] - AEON Biopharma, Inc. (AEON) edged up 1.80% to $1.13, confirming a meeting with the FDA and securing shareholder approval for financing transactions, simplifying its capital structure ahead of a second PIPE financing closing expected around January 27, 2026 [8]

Core Insights - Trevi Therapeutics announced positive results from the Phase 2b CORAL trial for oral nalbuphine ER, showing a statistically significant reduction in 24-hour objective cough frequency in patients with idiopathic pulmonary fibrosis (IPF) [1][2] - Over 60% of patients treated with nalbuphine ER achieved at least a 50% reduction in cough frequency at Week 6 compared to baseline [1] - The trial results were published in the Journal of the American Medical Association (JAMA), validating the findings and emphasizing the unmet need for chronic cough treatment in IPF patients [2] Company Overview - Trevi Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on developing Haduvio (oral nalbuphine ER) for chronic cough in patients with IPF, non-IPF interstitial lung disease, and refractory chronic cough [6] - Haduvio is the first investigational therapy to demonstrate a statistically significant reduction in cough frequency in clinical trials for both IPF chronic cough and refractory chronic cough [6] Trial Details - The Phase 2b CORAL trial was a double-blind, randomized, placebo-controlled study involving 165 patients, evaluating three doses of nalbuphine ER (27 mg, 54 mg, and 108 mg) over a 6-week period [5] - The primary efficacy endpoint was the relative change in 24-hour cough frequency, measured objectively, at the end of Week 6 compared to baseline [5] Safety Profile - The safety results of the CORAL trial were consistent with the known safety profile of nalbuphine ER, with discontinuation rates due to adverse events being similar between nalbuphine ER (5.6%) and placebo (5.0%) groups [3] - Common adverse events included nausea, vomiting, constipation, dizziness, headache, fatigue, somnolence, and dry mouth [3] Industry Context - Chronic cough in patients with IPF represents a significant unmet medical need, with approximately 150,000 patients in the U.S. and two-thirds experiencing uncontrolled chronic cough [4] - The impact of chronic cough is profound, with patients potentially coughing up to 1,500 times per day, leading to increased morbidity and a decline in quality of life [4]