Trevi Therapeutics Reports Strong Clinical Progress for Haduvio, Secures FDA Alignment for Phase 3, and Extends Cash Runway into 2028

summarizeSummary

This annual report details significant positive advancements for Trevi Therapeutics, particularly in its Haduvio clinical programs. The successful Phase 2b CORAL trial for IPF-related chronic cough and subsequent FDA alignment on a pivotal Phase 3 program are critical de-risking events for the company's lead candidate. Positive Phase 2a data for refractory chronic cough (RCC) and plans for a Phase 2b trial further demonstrate pipeline progression. The favorable human abuse potential study results are also a key de-risking factor for potential DEA scheduling, which is crucial for commercialization. Financially, the company significantly strengthened its cash position through recent offerings and warrant exercises, extending its operational runway into 2028. While the company continues to incur losses and faces potential future dilution, the overall picture is one of substantial clinical and financial progress, providing a clearer path forward for its investigational therapy.

check_boxKey Events

• Extended Cash Runway

  Cash, cash equivalents, and marketable securities increased to $188.3 million as of December 31, 2025, from $107.6 million in 2024, providing sufficient funding for operating expenses and capital expenditure requirements into 2028.

• FDA Alignment for Haduvio Phase 3 in IPF-related Chronic Cough

  Following positive Phase 2b CORAL trial results in June 2025, the company achieved overall FDA alignment for two pivotal Phase 3 clinical trials for Haduvio in IPF-related chronic cough, with the first trial expected to initiate in Q2 2026.

• Progress in Refractory Chronic Cough (RCC)

  Positive topline data from the Phase 2a RIVER trial in March 2025 supports the plan to initiate a Phase 2b trial for Haduvio in RCC during Q2 2026.

• Favorable Human Abuse Potential (HAP) Study Results

  Topline results from the HAP study in December 2024 demonstrated a statistically significant lower 'Drug Liking' for oral nalbuphine compared to IV butorphanol, which is a positive indicator for potential DEA scheduling.

auto_awesomeAnalysis

This annual report details significant positive advancements for Trevi Therapeutics, particularly in its Haduvio clinical programs. The successful Phase 2b CORAL trial for IPF-related chronic cough and subsequent FDA alignment on a pivotal Phase 3 program are critical de-risking events for the company's lead candidate. Positive Phase 2a data for refractory chronic cough (RCC) and plans for a Phase 2b trial further demonstrate pipeline progression. The favorable human abuse potential study results are also a key de-risking factor for potential DEA scheduling, which is crucial for commercialization. Financially, the company significantly strengthened its cash position through recent offerings and warrant exercises, extending its operational runway into 2028. While the company continues to incur losses and faces potential future dilution, the overall picture is one of substantial clinical and financial progress, providing a clearer path forward for its investigational therapy.