Trevi Therapeutics Advances Toward Treatment for Debilitating Cough

Significant progress has been reported by Trevi Therapeutics in addressing chronic cough for individuals suffering from idiopathic pulmonary fibrosis (IPF). The publication of positive trial data in the Journal of the American Medical Association (JAMA) highlights the promise of its drug candidate, Haduvio, representing a pivotal corporate milestone. The key question now is whether this biopharmaceutical firm can leverage this momentum to successfully navigate the path to regulatory approval.

Following these clinical achievements, the company's regulatory strategy is now front and center. A critical End-of-Phase-2 meeting with the U.S. Food and Drug Administration (FDA) is scheduled for the first quarter of 2026. This meeting aims to finalize the clinical development pathway for a New Drug Application (NDA). Should discussions proceed favorably, management intends to initiate the Phase 3 program in the first half of that same year.

Operational steps are being bolstered by a recent executive appointment. Since January 6, 2026, David Hastings has assumed the role of Chief Financial Officer, tasked with guiding the company's financial strategy through upcoming clinical trials and potential future commercialization.

Concurrently, Trevi is expanding its research pipeline. Also slated for the first half of 2026 is the commencement of a Phase 2b study targeting refractory chronic cough (RCC).

Compelling Data from the CORAL Trial

The Phase 2b CORAL study demonstrated that the investigational therapy Nalbuphin ER achieved a statistically significant reduction in cough frequency. More than 60 percent of treated patients experienced at least a 50 percent decrease in their symptoms from baseline after six weeks.

Should investors sell immediately? Or is it worth buying Trevi Therapeutics?

The speed of the therapeutic effect is particularly noteworthy for its clinical relevance, with significant improvements measured as early as two weeks into treatment. Given the current lack of effective treatments for IPF-associated cough, Trevi is targeting a substantial area of unmet medical need.

Market Performance and Upcoming Catalysts

The company's shares have reflected the recent positive news flow, posting a gain of approximately 5.8 percent over a seven-day period. In Friday's trading session, the stock was quoted at $10.57, marking a slight decline of about 1.1 percent from the previous day's close. Despite this recent uptick, the equity continues to trade roughly 25 percent below its 52-week high, which was recorded in December 2025.

The upcoming FDA meeting in Q1 2026 represents the next major catalyst for Trevi Therapeutics. This is expected to be followed closely by the next quarterly earnings report in March, which should provide insight into the company's financial resources for the planned Phase 3 trials.

Key Upcoming Milestones:
* January 2026: CORAL study data published in the Journal of the American Medical Association (JAMA).
* Q1 2026: End-of-Phase-2 meeting with the FDA to align on the regulatory pathway.
* H1 2026: Planned initiation of the Phase 3 study in IPF patients.
* H1 2026: Start of a Phase 2b study in refractory chronic cough (RCC).