FDA Greenlights Trevi Therapeutics' Phase 3 Plan for IPF Cough Drug, Two Pivotal Trials to Start in 2026
Summary
Trevi Therapeutics announced a successful End-of-Phase 2 meeting with the FDA, gaining full alignment on the development program for Haduvio™ (oral nalbuphine ER) for idiopathic pulmonary fibrosis (IPF)-related chronic cough. This pivotal outcome confirms the company's plan to initiate two parallel Phase 3 clinical trials, with the first expected in Q2 2026 and the second in H2 2026. The FDA also agreed on the remaining Phase 1 studies necessary for a New Drug Application (NDA) submission. This news significantly de-risks the program, establishing a clear regulatory pathway for a drug addressing a high unmet medical need with no currently FDA-approved therapies. Traders will closely monitor the initiation and progress of these pivotal trials as the next major catalysts for the stock.
At the time of this announcement, TRVI was trading at $13.12 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $1.7B. The 52-week trading range was $4.24 to $14.39. This news item was assessed with positive market sentiment and an importance score of 9 out of 10. Source: GlobeNewswire.