Trevi Shares Surge 8,000% Amid $115M Raise and Positive Phase 2 Data

Introduction

Trevi Therapeutics Inc. (Nasdaq: TRVI) is a clinical-stage biopharmaceutical company headquartered in New Haven, Connecticut. Since its founding in March 2011, Trevi has focused on the development of Haduvio™ (oral nalbuphine extended-release), an investigational therapy targeting chronic cough in patients with idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease (non-IPF ILD), and refractory chronic cough (RCC). Haduvio acts on the cough reflex arc both centrally and peripherally as a kappa agonist and mu antagonist (KAMA), and it is the first investigational agent to achieve statistically significant reductions in cough frequency in controlled trials of patients with IPF and RCC.

Corporate Structure

Trevi employs between 11 and 50 people, encompassing functions in clinical operations, regulatory affairs, quality assurance, and corporate development. Its leadership team includes:

• Jennifer Good, Co-Founder, President & Chief Executive Officer, with prior CEO roles at Penwest Pharmaceuticals and board experience at Rhythm Pharmaceuticals.
• Michael Heffernan, Director and Founder/Chairman of Collegium Pharmaceutical, with over 25 years in pharmaceutical research and development and executive leadership.
• James Cassella, Ph.D., Chief Development Officer since October 2024, previously served as Chief Development Officer for Concert Pharmaceuticals, overseeing development activities leading to the successful FDA approval of an autoimmune JAK inhibitor.

Chronic cough by Brittany Colette

Recent Developments and News

• On June 5, 2025, Trevi closed a public offering of 20,010,000 shares at $5.75 per share (including 2,610,000 shares from the underwriters’ full exercise option), raising approximately $115.1 million before expenses.
• In 2025, Trevi reported results from its Phase 2b CORAL trial in IPF chronic cough and its Phase 2a RIVER trial in RCC, both achieving statistically significant reductions in cough frequency compared to placebo.
• During September 2025, Trevi leadership participated in the Wells Fargo Healthcare Conference and the Cantor Global Healthcare Conference, discussing Haduvio’s development path and the unmet needs in chronic cough treatment.

Financial and Strategic Analysis

As of September 11, 2025, TRVI shares traded at $9.62, with a daily volume of 2,449,947 shares—approximately 8,082% above its 29,942-share average volume—indicating increased market interest. With no commercial products to date, Trevi relies on equity financings and grant funding to support its pipeline. The $115 million raised in June 2025 is expected to extend its cash runway through the anticipated start of registrational Phase 3 trials. Trevi aims to leverage its Phase 2 data to initiate discussions with the U.S. Food and Drug Administration regarding a potential accelerated approval pathway, targeting a pivotal study in IPF chronic cough in 2026.

Market Position and Industry Context

Chronic cough affects up to 10% of adults and currently has no approved targeted therapies for IPF-associated or refractory presentations in the U.S. Trevi’s Haduvio is positioned as a KAMA therapy, addressing the central and peripheral neural hypersensitivity believed to drive chronic cough. Competitor pipelines include neuromodulators and neuromuscular blockers in earlier stages of development, but none have demonstrated robust Phase 2 efficacy in both IPF and RCC populations. If approved, Haduvio could potentially capture a share of the estimated multi-hundred-million-dollar market for chronic cough therapeutics.

tl;dr

– On June 5, 2025, Trevi Therapeutics raised $115.1 million in a fully exercised underwritten offering.
– Positive Phase 2b CORAL (IPF chronic cough) and Phase 2a RIVER (RCC) results announced in 2025 support registrational planning.
– TRVI shares are trading at $9.62 with a volume of 2.45 million (up 8,082% vs. average).
– Upcoming catalysts include a planned Phase 3 study initiation in IPF chronic cough and FDA engagement on accelerated approval.