Why Did Tvardi Therapeutics Stock Plummet 87% Pre-Market Today?

Tvardi Therapeutics (TVRD) on Monday said that its TTI-101, being evaluated in idiopathic pulmonary fibrosis (IPF), showed no benefit over placebo in a mid-stage trial.

The trial was designed to assess safety, pharmacokinetics, and exploratory outcomes related to lung function in patients with IPF. Idiopathic Pulmonary Fibrosis is a progressive lung disease where lung tissue thickens and scars, making it difficult to breathe. However, the study did not meet its goals, and no statistically significant differences between placebo and treatment arms were observed after a preliminary review of exploratory efficacy, it said.

Shares of the company plummeted 87% in Monday’s pre-market session. On Stocktwits, retail sentiment around TVRD stock rose from ‘bullish’ to ‘extremely bullish’ territory over the past 24 hours, while message volume rose from ‘low’ to ‘extremely high’ levels.

Tvardi said that preliminary data showed that patients’ baseline characteristics were mostly similar across treatment arms, including those who received the two doses of TTI-101 or those who received a placebo in the trial. Furthermore, lower discontinuation rates were observed in the placebo group compared to the therapy-treated arms, it added.

The company also noted that patients who demonstrated changes in the lung’s Forced Vital Capacity (FVC) were 41% for the placebo, and 39% and 44% for the 400mg and 800mg TTI-101-treated arms, respectively.

“In the aggregate, we did not observe a benefit of TTI-101 treatment in this IPF study. The limited data set, high variability within treatment arms, and unexpected performance of the placebo arm make it difficult to provide more definitive conclusions at this time,” CEO Imran Alibhai said.

The CEO added that the company is now conducting additional analyses to understand the trial findings further. He also noted that the company is on track to report preliminary data from the mid-stage trial of TTI-101 in hepatocellular carcinoma.

TVRD stock has risen about 127% this year and more than quadrupled over the past 12 months. 

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