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Trevi Therapeutics Aligns With FDA on Phase 3 Cough Trials

Story Highlights
  • Trevi secured FDA alignment on its remaining IPF-related chronic cough development plan following an End-of-Phase 2 meeting.
  • The company will launch two global Phase 3 nalbuphine ER trials in 2026, targeting cough frequency reduction in IPF-related chronic cough patients.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Trevi Therapeutics Aligns With FDA on Phase 3 Cough Trials

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Trevi Therapeutics ( (TRVI) ) just unveiled an announcement.

On March 9, 2026, Trevi Therapeutics reported that an End-of-Phase 2 meeting with the U.S. Food and Drug Administration resulted in overall alignment on its remaining development program for IPF-related chronic cough. The company obtained FDA agreement on the design of its planned Phase 3 program and the remaining Phase 1 work needed to support a future regulatory filing.

Trevi plans to run two global, randomized, double-blind, placebo-controlled Phase 3 trials of nalbuphine ER 54 mg twice daily, with the first starting in the second quarter of 2026 and the second in the second half of 2026. The larger study will enroll about 300 patients over 52 weeks with a 24-week primary endpoint, while the smaller will enroll about 130 patients over 12 weeks, and both will measure relative change in 24-hour cough frequency versus placebo, with final trial designs still subject to FDA protocol review.

The most recent analyst rating on (TRVI) stock is a Buy with a $22.00 price target. To see the full list of analyst forecasts on Trevi Therapeutics stock, see the TRVI Stock Forecast page.

Spark’s Take on TRVI Stock

According to Spark, TipRanks’ AI Analyst, TRVI is a Neutral.

Score is primarily held back by weak financial performance (pre-revenue, ongoing losses and elevated cash burn). Offsetting factors include a strong, low-leverage balance sheet and a positive earnings-call backdrop with substantial cash runway and encouraging clinical progress; technicals are moderately supportive, while valuation remains constrained by lack of profitability.

To see Spark’s full report on TRVI stock, click here.

More about Trevi Therapeutics

Trevi Therapeutics, Inc. is a biopharmaceutical company developing nalbuphine ER tablets for the treatment of idiopathic pulmonary fibrosis (IPF)-related chronic cough. The company is focused on advancing this therapy through late-stage clinical development to support a future New Drug Application in this niche respiratory indication.

Average Trading Volume: 1,532,524

Technical Sentiment Signal: Buy

Current Market Cap: $1.71B

Learn more about TRVI stock on TipRanks’ Stock Analysis page.

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