Tvardi Therapeutics Announces Further Phase 2 REVERT IPF Data, Expanding Clinical Insights
Rhea-AI Summary
Tvardi Therapeutics (NASDAQ: TVRD) reported additional analyses from its Phase 2 REVERT IPF trial of TTI-101, focusing on 40 patients exposed to study drug for 12 weeks (16 pooled TTI-101, 24 placebo). Key findings: fibrosis score declined -9.4% with TTI-101 vs -2.4% for placebo (centrally read); greater IL-6 reductions observed with TTI-101, especially in patients with higher baseline IL-6; 63% of TTI-101 patients had FVC increases at 12 weeks vs 46% placebo, and mean FVC change was -15mL vs -22mL for REVERT placebo. The company noted the Phase 2 study overall did not meet its goals and is awaiting Phase 1 TTI-109 healthy volunteer topline data in H1 2026.
Positive
- Fibrosis score decline of -9.4% vs -2.4% placebo
- Greater IL-6 reductions observed with TTI-101
- 63% of TTI-101 patients showed FVC increase at 12 weeks
- Mean FVC change -15mL vs REVERT placebo -22mL
Negative
- Phase 2 study overall did not meet its goals (announced Oct 13, 2025)
- Small evaluable cohort: 16 TTI-101 patients and 24 placebo patients
- Four patients removed from 12-week analysis for dosing/PK/outlier reasons
- Results are preliminary and limited to a 12-week exposure window
News Market Reaction
On the day this news was published, TVRD gained 8.74%, reflecting a notable positive market reaction. Argus tracked a peak move of +12.5% during that session. Our momentum scanner triggered 14 alerts that day, indicating notable trading interest and price volatility. This price movement added approximately $4M to the company's valuation, bringing the market cap to $44M at that time.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Market Reality Check
Peers on Argus
TVRD was down 1.02% pre-news while several biotech peers showed modest gains (e.g., DSGN and LBRX up, CTMX up) and IMRX appeared in momentum scanners with a -23.17% move, indicating stock-specific dynamics rather than a coordinated sector move.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Nov 18 | Conference participation | Neutral | +2.2% | Participation in Piper Sandler healthcare conference with webcasted fireside chat. |
| Nov 13 | Earnings update | Negative | -3.1% | Q3 2025 loss, going-concern language, and reminder REVERT IPF missed goals. |
| Nov 04 | Conference presentation | Neutral | -2.7% | Jefferies conference presentation and investor meetings focusing on STAT3 programs. |
| Oct 13 | Clinical trial update | Negative | -83.9% | Preliminary REVERT IPF data showed study did not meet its goals. |
| Aug 21 | Conference participation | Neutral | -0.9% | Cantor conference participation and fireside chat on STAT3 pipeline. |
Clinical trial setbacks for TTI-101 in IPF previously coincided with a sharp selloff, while conference and general news items have led to relatively modest single-digit moves.
Over the last six months, Tvardi moved from completing REVERT IPF enrollment to reporting that the Phase 2 study did not meet its goals on Oct 13, 2025, which saw a -83.92% move. Subsequent Q3 2025 results highlighted ongoing losses and runway into Q4 2026. Later conference and investor events in Nov 2025 produced smaller price changes. Today’s announcement adds deeper 12‑week analyses and STAT3 pathway readouts on TTI‑101 and reiterates timelines for TTI‑109.
Market Pulse Summary
The stock moved +8.7% in the session following this news. A strong positive reaction aligns with the stock’s history of large moves around REVERT IPF milestones, including the -83.92% drop on the October 2025 miss. Today’s deeper 12‑week data highlight fibrosis scoring, IL‑6 changes, and FVC trends plus a path forward for TTI‑109. However, prior volatility, going-concern language in recent filings, and the earlier failure to meet trial goals could all temper the durability of any sharp upside move.
Key Terms
idiopathic pulmonary fibrosis medical
stat3 medical
il-6 medical
fvc medical
pharmacokinetics medical
placebo-controlled medical
AI-generated analysis. Not financial advice.
Pooled patients treated with TTI-101 demonstrated a
Topline healthy volunteer data from Phase 1 study of next-generation STAT3 inhibitor, TTI-109, on track for H1 2026
HOUSTON, Jan. 08, 2026 (GLOBE NEWSWIRE) -- Tvardi Therapeutics, Inc. (“Tvardi”) (NASDAQ: TVRD), a clinical-stage biopharmaceutical company focused on the development of novel, oral, small molecule therapies targeting STAT3 to treat fibrosis-driven diseases, today provided further updates from its Phase 2 REVERT IPF clinical trial of TTI-101 in idiopathic pulmonary fibrosis (IPF). Preliminary results were announced on October 13, 2025.
Additional analysis was conducted to interrogate the impact of STAT3 inhibition using TTI-101 on fibrosis, inflammatory markers and pulmonary function. In order to do so, the additional analysis was limited to patients who were exposed to study drug for 12 weeks. Upon interrogation of pharmacokinetics and adverse events, one patient was removed from the analysis due to receiving less than
Data highlights:
- Fibrosis: Fibrosis decline was greater in patients treated with TTI-101 compared to placebo, -
9.4% vs -2.4% , respectively, in baseline-weighted high resolution CT lung fibrosis score (centrally read, blinded and independently assessed). - Inflammation: A greater IL-6 decline was observed among TTI-101-treated patients vs placebo. In addition, greater reduction in IL-6 was observed among patients with higher baseline IL-6 in the TTI-101-treated patients. IL-6 is a key pro-inflammatory cytokine that signals through STAT3. Inhibition of STAT3 is expected to reduce downstream inflammatory signaling associated with disease.
63% of pooled patients treated with TTI-101 demonstrated an increase in FVC at 12 weeks, compared to46% of the placebo group.- Mean FVC change in TTI-101-treated patients was -15mL; less of a decline when compared to the REVERT placebo (-22mL) and historical placebo groups from comparable IPF trials.
Imran Alibhai, Ph.D., Chief Executive Officer of Tvardi, stated, “Our subsequent analyses of the REVERT IPF clinical trial data set revealed deeper insights into the impact of TTI-101 on the inhibition of STAT3 in fibrosis and inflammation. Notably, treatment with TTI-101 was associated with improvement in blinded fibrosis scores vs placebo and reductions in IL-6 levels consistent with STAT3 pathway inhibition. Further interrogation into FVC after 12 weeks of TTI-101 was encouraging despite the placebo-treated patients’ FVC decline being lower than expected compared to historical controls.
“With these data in-hand, we eagerly await results from the ongoing healthy volunteer study of our next-generation STAT3 inhibitor, TTI-109. TTI-109 is designed to enhance TTI-101’s ability to target STAT3 as a more efficient delivery vehicle with the potential to improve tolerability. If successful, we will move quickly to identify next steps for this promising, potentially disease modifying therapy across a range of fibrosis-driven diseases where STAT3 activation is implicated.”
The REVERT IPF Phase 2 clinical trial was a randomized, double-blind, placebo-controlled clinical trial of TTI-101 alone or in addition to nintedanib (OFEV®) in patients with IPF. The study was designed to assess safety, pharmacokinetics, and exploratory outcomes related to lung function. Tvardi announced on October 13, 2025 that the study did not meet its goals after reviewing preliminary safety data and efficacy results.
About Tvardi Therapeutics
Tvardi is a clinical-stage biopharmaceutical company focused on the development of novel, oral small molecule therapies targeting STAT3 to treat fibrosis-driven diseases with significant unmet need. STAT3 is a central mediator across critical fibrotic signaling pathways that drive uncontrolled deposition, proliferation, survival and immune suppression. 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-101 in hepatocellular carcinoma (NCT05440708) and TTI-109 in healthy volunteers. To learn more, please visit tvardi.com or follow us on LinkedIn and X (Twitter).
Contacts:
For Tvardi:
Tvardi Investor Relations
ir@tvardi.com
PJ Kelleher
LifeSci Advisors
617-430-7579
pkelleher@lifesciadvisors.com
Cautionary Statement Regarding Forward-looking Statements
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the anticipated benefits of Tvardi’s product candidates; its ongoing clinical trials and anticipated timing of reporting data from such trials; potential indications for its product candidates; and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future, and, therefore, you are cautioned not to place undue reliance on them.
Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are subject to a number of risks, including, among other things: the uncertainties associated with Tvardi’s product candidates, as well as risks associated with the clinical development and regulatory approval of product candidates, including potential delays in the completion of clinical trials; the significant net losses Tvardi has incurred since inception; Tvardi’s ability to initiate and complete ongoing and planned preclinical studies and clinical trials and advance its product candidates through clinical development; the timing of the availability of data from Tvardi’s clinical trials; the outcome of preclinical testing and clinical trials of the Tvardi’s product candidates, including the ability of those trials to satisfy relevant governmental or regulatory requirements; Tvardi’s plans to research, develop and commercialize its current and future product candidates; the clinical utility, potential benefits and market acceptance of Tvardi’s product candidates; the requirement for additional capital to continue to advance these product candidates, which may not be available on favorable terms or at all; Tvardi’s anticipated cash runway; Tvardi’s ability to attract, hire, and retain skilled executive officers and employees; Tvardi’s ability to protect its intellectual property and proprietary technologies; Tvardi’s reliance on third parties, contract manufacturers, and contract research organizations; the possibility that Tvardi may be adversely affected by other economic, business, or competitive factors; risks associated with changes in applicable laws or regulations; those factors discussed in Tvardi’s filings with the Securities and Exchange Commission, including the “Risk Factors” section of the Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, and Tvardi’s other documents subsequently filed with or furnished to the SEC, all of which are available on the SEC’s website at www.sec.gov. All forward-looking statements contained in this press release speak only as of the date on which they were made. The company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law.
FAQ
What did Tvardi (TVRD) report from the Phase 2 REVERT IPF trial on January 8, 2026?
How many patients were included in the 12-week TTI-101 analysis in REVERT IPF?
What lung function changes did Tvardi report for TTI-101 at 12 weeks?
What biomarker effect did TTI-101 show in the REVERT IPF analysis?
When will Tvardi report topline data for the next-generation STAT3 inhibitor TTI-109?
