Every 8-K that Tvardi Therapeutics, Inc. (TVRD) 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 TVRD 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 TVRD filings page.
Tvardi Therapeutics reported second-quarter 2026 results and clinical progress on its STAT3 inhibitor programs. The company highlighted topline healthy-volunteer results for next-generation STAT3 inhibitor TTI-109, which confirmed its prodrug design, showed improved tolerability and reductions in disease-relevant immune cell populations. Tvardi also selected ulcerative colitis as the initial indication for TTI-109 and plans a KOL webinar on its clinical potential.
For the quarter ended June 30, 2026, research and development expense was $4.0 million, down from $5.8 million a year earlier, and general and administrative expense was $2.6 million, down from $3.1 million. Tvardi reported a net loss of $6.5 million, versus net income of $4.2 million in the prior-year period, which had included a $12.7 million non-cash gain from revaluation of convertible notes. Cash, cash equivalents and short-term investments totaled $15.8 million at June 30, 2026, compared with $30.8 million at December 31, 2025. Management anticipates existing liquidity will fund operations, as currently planned, through the hepatocellular carcinoma topline readout into the third quarter of 2027, while advancing TTI-109 into ulcerative colitis and additional indications will require further funding and IND clearance.
Tvardi Therapeutics, Inc. has selected ulcerative colitis (UC) as the initial disease indication for its next‑generation oral STAT3 inhibitor TTI‑109. This decision follows a Phase 1 healthy volunteer study in which TTI‑109 modulated multiple STAT3‑driven immune cell populations, including Th17, T follicular helper and B cells implicated in UC pathology, with what the company describes as a differentiated safety profile from JAK inhibitors across more than 400 subjects dosed with its STAT3 inhibitors.
The company plans to initiate a study of TTI‑109 in patients with moderate‑to‑severe UC in 2027, subject to Investigational New Drug clearance and additional funding. Safety will be the primary endpoint, with clinical remission at 12 weeks as a key secondary endpoint and exploratory pharmacodynamic analyses of serum and tissue biomarkers and single nucleotide polymorphisms. Tvardi highlights UC as a large, underserved market with more than 1.25 million diagnosed patients in the United States and an estimated addressable market of approximately $3 billion domestically and $9 billion globally, while it continues to advance related STAT3 inhibitor TTI‑101 in hepatocellular carcinoma and other fibrotic and inflammatory settings.
Tvardi Therapeutics, Inc. filed a prospectus supplement to increase its existing at-the-market offering program, permitting the issuance of up to $9,689,765 in additional shares of common stock under its Capital on Demand™ Sales Agreement with JonesTrading Institutional Services LLC.
The shares are issued under an effective shelf registration statement on Form S-3 registering up to $12.5 million of common stock. The company is subject to General Instruction I.B.6 of Form S-3, the baby shelf rule, and reports an aggregate market value of non-affiliate common stock of $62,208,945, based on 12,441,789 non-affiliate shares at $5.00 per share. Over the prior twelve-month period, it sold 3,110,769 shares for approximately $11.0 million in gross proceeds under the earlier sales agreement prospectus, and no additional stock will be sold under that earlier prospectus.
Tvardi Therapeutics reported Phase 1 results for TTI-109, an oral phosphate prodrug of its STAT3 inhibitor TTI-101, showing it rapidly converts to TTI-101 and achieves dose-proportional exposures above the STAT3 IC₅₀ in healthy volunteers.
Across single and multiple ascending dose cohorts, TTI-109 delivered TTI-101-equivalent systemic exposure at molar-equivalent doses and showed an improved gastrointestinal tolerability profile, with diarrhea rates and duration closer to placebo than TTI-101. Exploratory pharmacodynamic analyses found reductions of up to 60% in STAT3-driven immune cell populations, including Th17, T follicular helper and B cells, which are implicated in inflammatory and proliferative dermatologic and gastrointestinal diseases. Tvardi plans to advance TTI-109 into Phase 2 trials in these indications, subject to IND clearance and additional funding, while continuing its Phase 1b/2 REVERT LIVER CANCER trial of TTI-101 in hepatocellular carcinoma and targeting topline data in the second half of 2026.
Tvardi Therapeutics, Inc. reported the voting results from its Annual Meeting of Stockholders held on June 9, 2026. Stockholders elected Imran Alibhai, Ph.D., Cynthia Smith and Sujal Shah as Class II directors to serve until the 2029 annual meeting.
They also approved, on a non-binding advisory basis, the compensation of the company’s named executive officers and indicated a preference for holding this advisory vote every year. In addition, stockholders ratified the Audit Committee’s selection of Deloitte & Touche LLP as the independent registered public accounting firm for the fiscal year ending December 31, 2026.
Tvardi Therapeutics, Inc. reported first quarter 2026 results and highlighted upcoming clinical milestones. Research and development expenses rose to $4.9 million from $3.1 million a year earlier, mainly from higher costs for next-generation STAT3 inhibitor TTI-109, partly offset by lower spending on TTI-101.
General and administrative expenses increased to $2.1 million from $1.2 million, driven by higher personnel, stock-based compensation and public-company costs. Net loss narrowed to $6.8 million from $9.6 million, with net loss per share improving to $(0.73) from $(3.72).
Cash, cash equivalents and short-term investments were $25.0 million as of March 31, 2026, down from $30.8 million at year-end 2025. Tvardi expects this cash to fund operations through key clinical readouts and into the fourth quarter of 2026, including June topline data for TTI-109 and second-half 2026 topline data from the Phase 2 REVERT LIVER CANCER trial of TTI-101.
Tvardi Therapeutics reported fourth quarter and full-year 2025 results showing lower expenses and a narrower loss while advancing its STAT3 inhibitor pipeline. Research and development spending fell to $5.5 million in the quarter and $18.0 million for 2025, down from $8.6 million and $23.7 million in 2024, mainly as TTI-101 clinical costs declined.
Net loss improved to $7.3 million for the quarter and $18.2 million for the year, compared with $12.7 million and $29.4 million a year earlier. Cash, cash equivalents and short-term investments totaled $30.8 million as of December 31, 2025, and the company expects this to fund operations through key clinical readouts and into the fourth quarter of 2026.
The company highlighted upcoming milestones, including healthy volunteer data for next-generation STAT3 inhibitor TTI-109 in Q2 2026 and topline Phase 2 data for TTI-101 in hepatocellular carcinoma in the second half of 2026.
Tvardi Therapeutics, Inc. has scheduled its 2026 Annual Meeting of Stockholders for June 9, 2026. Stockholder proposals seeking inclusion in the company’s proxy materials under SEC Rule 14a-8 must be received at the principal executive offices by March 16, 2026.
For other business or director nominations brought directly before the meeting under the company’s Amended and Restated Bylaws, stockholders must also submit notice by March 16, 2026. Separate notice for soliciting proxies in support of alternative director nominees in compliance with SEC Rule 14a-19 is due by April 10, 2026.
Tvardi Therapeutics, Inc. filed a current report to let investors know that it has released an updated corporate presentation. The new presentation, dated January 16, 2026, has been posted on the company’s website and is also included with the report as Exhibit 99.1.
The disclosure is made under Regulation FD, which is designed to ensure that all investors have access to the same information at the same time. The company also notes that this material is being furnished rather than filed, meaning it is not subject to certain liability provisions of the federal securities laws and is not automatically incorporated into other SEC filings.
Tvardi Therapeutics, Inc. approved one-time equity retention awards for key executives and adopted a new severance and change in control plan. On December 16, 2025, the Board granted options to purchase 47,500 shares to Chief Executive Officer Dr. Imran Alibhai and 17,500 shares each to Chief Medical Officer Dr. John Kauh and Chief Financial Officer Dan Conn to support performance as the company advances its TTI-101 and TTI-109 clinical programs.
The new Severance and Change in Control Plan covers certain employees, including all named executive officers, and provides cash severance, bonus-related payments, Company-paid COBRA premiums and equity vesting acceleration upon qualifying terminations. Benefits are more substantial if a termination occurs from three months before to 12 months after a change in control, including lump sum salary and bonus payments and full acceleration of unvested time-based equity awards. Outside that period, salary is paid over time and equity accelerates only to the extent it would have vested within defined future periods.
Tvardi Therapeutics, Inc. reported that it has made an updated corporate presentation available on its website. The company describes this as a general information update under Regulation FD, aimed at providing the same information to all market participants at the same time.
The updated presentation is also furnished as an exhibit to the current report, dated November 19, 2025. Because it is furnished rather than filed, the material is not subject to certain liability provisions of the federal securities laws and is not automatically incorporated into other regulatory submissions.
Tvardi Therapeutics, Inc. filed a current report to furnish a press release announcing its financial results and business highlights for the fiscal quarter ended September 30, 2025. The company issued the press release on November 13, 2025, and attached it as Exhibit 99.1.
The information about results and highlights is furnished under Item 2.02 of the Exchange Act and is not deemed filed or incorporated by reference into other SEC filings. The report also includes an Inline XBRL cover page as Exhibit 104.
Tvardi Therapeutics, Inc. (TVRD) filed a Form 8-K announcing a press release about preliminary data from its Phase 2 REVERT trial in idiopathic pulmonary fibrosis. The company stated the full text of the press release, titled “Tvardi Therapeutics Provides Update on Preliminary Data from Phase 2 REVERT Trial in Idiopathic Pulmonary Fibrosis,” is furnished as Exhibit 99.1 and incorporated by reference.
Tvardi Therapeutics, Inc. filed a Form 8-K to furnish a press release announcing its financial results for the fiscal quarter ended June 30, 2025. The company, formerly known as Cara Therapeutics, issued the release on August 14, 2025, and attached it as Exhibit 99.1.
The disclosure is provided under Item 2.02, "Results of Operations and Financial Condition," and is expressly described as being "furnished" rather than "filed," which limits its applicability for certain securities law liability provisions and for automatic incorporation by reference into other SEC filings.