Every 8-K that Trevi Therapeutics (TRVI) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow TRVI and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full TRVI filings page.
Trevi Therapeutics reported second-quarter 2026 results and progress on Haduvio, its oral nalbuphine ER program for chronic cough in idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease and refractory chronic cough. The company initiated the Phase 3 OCEAN-1 trial in IPF-related chronic cough and the Phase 2b LAKE trial in refractory chronic cough; the Phase 3 OCEAN-2 trial is expected to start in the third quarter of 2026, with topline data from OCEAN-2 and LAKE expected in the second half of 2027 and from OCEAN-1 in the first half of 2028.
Cash, cash equivalents and marketable securities totaled $318.9 million following an April 2026 underwritten offering that generated about $162.3 million in net proceeds, which the company expects to extend its cash runway into 2030 and fund multiple Haduvio development programs. In the quarter, research and development expenses rose to $15.2 million, general and administrative expenses to $5.4 million, and net loss to approximately $17.8 million, or $0.11 per share.
Trevi Therapeutics, Inc. reported results of its 2026 annual stockholder meeting, where investors approved several governance and capital measures. Stockholders adopted an Amended and Restated 2019 Stock Incentive Plan, adding 8,000,000 shares of common stock for future equity awards and tightening rules on director pay, share recycling, and dividend treatment on awards.
They also approved an amendment to the restated certificate of incorporation to increase authorized common shares from 200,000,000 to 400,000,000, which became effective upon filing a Certificate of Amendment in Delaware on June 3, 2026. Stockholders elected Michael Heffernan as a Class I director through the 2029 annual meeting, ratified Ernst & Young LLP as independent auditor for the 2026 fiscal year, and gave advisory approval to executive compensation.
Trevi Therapeutics, Inc. reported a first quarter 2026 net loss of $13.2 million, or $0.09 per share, as it increased investment in its chronic cough pipeline. Research and development and general and administrative expenses both rose versus the prior-year period.
The company ended the quarter with $171.8 million in cash, cash equivalents and marketable securities and then completed an underwritten common stock offering in April 2026 that generated approximately $162 million in net proceeds. Trevi now expects its cash runway to extend into 2030, supporting Phase 3 trials in IPF-related chronic cough, Phase 2b trials in non-IPF ILD-related chronic cough and refractory chronic cough, and a potential FDA submission for Haduvio.
Trevi Therapeutics entered an underwriting agreement for an underwritten public offering of 11,600,000 shares of common stock at $13.00 per share, all sold by the company. Underwriters will buy the shares at $12.22 per share, and have a 30-day option to purchase up to 1,740,000 additional shares at the same terms.
Trevi estimates net proceeds of about $141.1 million, or $162.4 million if the option is fully exercised, to be raised under its effective Form S-3 shelf. It estimates cash, cash equivalents and marketable securities of approximately $171.8 million as of March 31, 2026, and believes existing cash plus offering proceeds will fund operations and planned Haduvio clinical trials through 2029, though not commercialization or all indications, so additional capital will still be required.
Trevi Therapeutics reported fourth-quarter and full-year 2025 results and outlined plans to advance its chronic cough pipeline. The company is developing Haduvio, an oral nalbuphine extended-release therapy for chronic cough in idiopathic pulmonary fibrosis (IPF), non-IPF interstitial lung disease, and refractory chronic cough.
Trevi ended 2025 with $188.3 million in cash, cash equivalents and marketable securities, which it expects will fund operations into 2028. For 2025, research and development expenses fell to $33.5 million from $39.4 million, while general and administrative costs rose to $15.9 million from $12.1 million. The net loss narrowed to $42.8 million from $47.9 million in 2024.
The company gained overall FDA alignment on its Phase 3 program for IPF-related chronic cough and plans two pivotal Phase 3 trials beginning in 2026. It also plans Phase 2b trials in 2026 for refractory chronic cough and for non-IPF ILD-related chronic cough, and will host an Investor and Analyst Day on May 7, 2026.
Trevi Therapeutics, Inc. is moving its lead program for IPF-related chronic cough into late-stage testing after reaching overall alignment with the U.S. Food and Drug Administration at an End-of-Phase 2 meeting. The company plans two pivotal Phase 3 trials of nalbuphine ER tablets, both randomized, double-blind, placebo-controlled, multicenter and global, using a 54 mg twice-daily dose.
The first trial is planned to enroll about 300 patients with 52 weeks of fixed dosing and a primary endpoint at 24 weeks. The second trial is planned to enroll about 130 patients with 12 weeks of fixed dosing. In both, patients will be randomized 2:1 to nalbuphine ER or placebo, and the primary efficacy endpoint will be the relative change from baseline in 24-hour cough frequency, measured by an objective cough monitor. These designs remain subject to the FDA’s final protocol review.
Trevi Therapeutics (TRVI) announced financial results for the quarter ended September 30, 2025, and furnished a detailed press release as Exhibit 99.1. The disclosure under Item 2.02 is furnished, not filed, and is not subject to Section 18 liability or incorporated by reference unless specifically referenced.
Trevi Therapeutics reports that Chief Financial Officer Lisa Delfini will end her employment and resign as CFO on August 22, 2025. The company states that her resignation is not due to any disagreement over operations, policies, or practices. In line with its Executive Separation Benefits and Retention Plan, Trevi has agreed to provide her with separation benefits, conditioned on signing a severance and release agreement that includes a general release of claims, a non-disparagement commitment, and reaffirmation of existing confidentiality, non-solicitation, and non-compete obligations.
As of the effective date of her departure, President and Chief Executive Officer Jennifer L. Good will also serve as the company’s principal financial officer on an interim basis until a new principal financial officer is designated.