Common Stock, par value $0.001 per share
- Symbol
- TVRD
- Exchange
- NASDAQ
- Classification
- COMMON
- Status
- Current
Current Report · Items 7.01, 9.01 · 8-K
Tvardi Therapeutics, Inc.
TVRDNASDAQEQUITYCurrent
Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure. On July 7, 2026, Tvardi Therapeutics, Inc. (the "Company") issued a press release entitled "Tvardi Therapeutics' TTI-109 Phase 1 Study Confirms Prodrug Design, Improved Tolerability and Pharmacodynamic Evidence of STAT3 Target Engagement." The press release provides certain clinical updates on TTI-109.…
Company context
Tvardi is a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat inflammatory and proliferative diseases with significant unmet need. STAT3 is a central mediator across critical signaling pathways that drive uncontrolled proliferation, survival and immune dysregulation. STAT3 is also positioned at the intersection of many signaling pathways integral to the survival and immune evasion of cancer cells. The Company is conducting clinical trials with TTI-109 in healthy volunteers and TTI-101 in hepatocellular carcinoma (NCT05440708). To learn more, please visit tvarditherapeutics.com or follow us on LinkedIn and X (Twitter).
Current securities
Registered securities in this filing
TVARDI THERAPEUTICS, INC. · 8-K · Filed 2026-07-07
Disclosure sections
Item 7.01Item 7.01 - Regulation FD Disclosure
Item 7.01 Regulation FD Disclosure.
On July 7, 2026, Tvardi Therapeutics, Inc. (the
"Company") issued a press release entitled "Tvardi Therapeutics' TTI-109 Phase 1 Study Confirms Prodrug Design,
Improved Tolerability and Pharmacodynamic Evidence of STAT3 Target Engagement." The press release provides certain clinical updates
on TTI-109. The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and incorporated herein
by reference.
On July 7, 2026, the Company also made available
an updated corporate presentation to be used to discuss the clinical updates on TTI-109. A copy of the presentation is attached as Exhibit
99.2 to this Current Report on Form 8-K.
The information in this Item 7.01 of this Current
Report on Form 8-K (including Exhibits 99.1 and 99.2) is being furnished and shall not be deemed "filed" for purposes of Section
18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities
of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange
Act, except as expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. Description
─────────────────────────────────────────────────────────────────────────────────────────────────
99.1 Press release issued on July 7, 2026.
99.2 Corporate presentation, dated July 7, 2026.
104 Cover Page Interactive Data File (embedded within the Inline XBRL document).
Filed exhibits (2)
EX-99.1 2 tm2619879d1_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 Tvardi Therapeutics’ TTI-109 Phase 1 Study Confirms Prodrug Design, Improved Tolerability and Pharmacodynamic Evidence of STAT3 Target Engagement TTI-109 delivered TTI-101-equivalent exposure with improved tolerability and meaningful reductions in disease-relevant STAT3-driven immune cell populations including Th17, T follicular helper (Tfh) and B cells Company plans to advance TTI-109 into STAT3-driven dermatologic and gastrointestinal (GI) diseases - subject to additional funding Company to host investor webcast today, July 7 th, at 8:30am ET HOUSTON, TX - July 7, 2026 -- Tvardi Therapeutics, Inc. (“Tvardi” or the “Company”) (NASDAQ: TVRD), a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat inflammatory and proliferative diseases, today announced Phase 1 results for TTI-109, its next-generation STAT3 inhibitor. TTI-109 is a phosphate prodrug of TTI-101 designed to improve delivery and tolerability while preserving the parent compound's mechanism of action. The study confirmed rapid prodrug conversion, dose-proportional pharmacoki…
Open exhibit ↗EX-99.2 3 tm2619879d1_ex99-2.htm EXHIBIT 99.2 Exhibit 99.2 Overview July 2026 This presentation contains forward - looking statements that involve substantial risks and uncertainties. All statements, other th an statements of historical facts, contained in this presentation, including statements about our expectations regarding the potential benefits, activity, effec tiv eness, and safety of our product candidates, our expectations with regard to the design and results of our research and development programs, preclinical studies, and cli nic al trials, including the timing and availability of data from such studies and trials, our preclinical, clinical, and regulatory development plans for our product candidates, including the timing or likelihood of regulatory filings and approvals for our product candidates, our expectations with regard to our ability to license, acqui re, discover, and develop additional products candidates and advance such product candidates into, and successfully complete, preclinical studies and clinical trials, the pot ential market size and size of the potential patient populations for our product candidates and any future product candidates, our abi…
Open exhibit ↗