Tvardi Therapeutics, Inc. Securities Lawsuit Investigation

Shamis & Gentile P.A., a law firm that advocates for investors who are victims of securities fraud, is investigating potential claims against Tvardi Therapeutics, Inc. (TVRD)

If you purchased or acquired Tvardi Therapeutics securities from May 2025 through early-October 2025, you may be eligible to join this securities investigation and seek compensation.

About Tvardi Therapeutics

Tvardi Therapeutics is a clinical-stage biopharmaceutical company focused on developing therapies for serious diseases, including idiopathic pulmonary fibrosis (IPF) and cancer.

The company also completed a merger with Cara in April 2025, which resulted in a new share structure and updated board composition.

Potential Concerns Under Investigation

Lawyers are investigating whether Tvardi Therapeutics may have made misleading statements or failed to disclose important information to investors regarding its lead product candidate, TTI-101, and the pivotal Phase 2 REVERT trial in IPF.

On October 13, 2025, Tvardi Therapeutics publicly disclosed that the Phase 2 REVERT IPF trial had failed to meet its goals. The company stated it had reviewed "the preliminary safety data and exploratory efficacy results" and "concluded that the study did not meet its goals."

The press release detailed that there were no statistically significant differences between placebo and treatment arms, and the placebo group showed a lower decline in lung function compared to those receiving TTI-101. The company also disclosed higher discontinuation rates in the TTI-101 arms (56-62%) compared to placebo (10.3%).

Following this news, Tvardi Therapeutics' stock price declined approximately 84%, dropping from a close of about $41.60 on October 10, 2025 to a closing price of $6.69 on October 13, 2025; representing a significant reduction in market capitalization. Trading volume increased to about 6.35 million shares, compared to 40,000 - 80,000 shares on prior days.

Legal professionals are examining previous statements by Tvardi Therapeutics and its executives regarding the trial. In the May 27, 2025, enrollment announcement, management cited TTI-101's "unique and powerful dual mechanism" and stated it resulted in "reduced lung fibrosis and restored lung function in preclinical studies."

In the second quarter 2025 results, management stated, "We are on track for topline data in the fourth quarter from our fully enrolled REVERT IPF Phase 2 clinical trial," and that positive data would further validate their approach.

Attorneys may investigate if the company adequately disclosed emerging risks or negative developments, such as the decision to discontinue the 1200mg arm of the trial after a safety review, as mentioned in the Q2 2025 Form 10-Q. The investigation might also look into whether shareholders were informed about high dropout rates and potential imbalances in the trial before the negative results were revealed.

Your Rights and Next Steps

This is an active investigation into whether Tvardi Therapeutics or its executives may have made statements or omissions that led to investor losses. Investors who purchased or acquired Tvardi Therapeutics securities, and suffered losses may be eligible to participate in any future class action that could arise from this investigation.

Lawyers are ready to help investors understand their rights and options. If the investigation develops into a class action lawsuit, eligible investors may be able to seek compensation for their losses. It is important for investors to act quickly, as securities investigations and potential lawsuits are often time-sensitive.

Investors are encouraged to gather and retain documentation of their purchases, sales, and holdings of Tvardi Therapeutics securities during the relevant period. This information may be necessary to support a claim if a class action is filed.

You May Be Entitled to Compensation

If you purchased or acquired Tvardi Therapeutics securities between May 2025 and early-October 2025, you may be eligible to join any potential class action and seek compensation. Securities investigations can move quickly, and there may be deadlines to participate.

To protect your rights and learn more about your options, complete the form below to join the investigation.