United Therapeutics Corporation (NASDAQ:UTHR) shares surged more than 35% following the release of positive late-stage clinical trial results for its lung disease drug Tyvaso.
The company said its TETON-2 study evaluating nebulized Tyvaso in patients with idiopathic pulmonary fibrosis (IPF) met its primary endpoint, showing significant improvements in lung function compared with placebo over a 52-week period.
According to United Therapeutics, patients treated with Tyvaso experienced an average increase in forced vital capacity (FVC) of 95.6 mL from baseline, a statistically significant improvement over placebo.
Benefits were reported across all patient subgroups, including those on existing anti-fibrotic therapies, smokers, and patients using supplemental oxygen.
The study also demonstrated significant improvements in several secondary endpoints, including time to first clinical worsening event, percent predicted FVC, lung diffusion capacity, and quality of life measures.
Trends favored Tyvaso for time to first acute exacerbation of IPF and overall survival, although these were not statistically significant, the company noted.
The drug was well-tolerated, with a safety profile consistent with previous studies.
“These overwhelmingly positive data send a clear signal of the potential benefits of Tyvaso for patients with IPF,” said Peter Smith, senior vice president of product development at United Therapeutics.
United Therapeutics plans to use TETON-2 and the ongoing TETON-1 study results to support a supplemental New Drug Application to the US Food and Drug Administration to expand Tyvaso’s label to include IPF.
The company expects TETON-1 results in the first half of 2026 and aims to meet with the FDA later this year to discuss potential regulatory acceleration.
Additional TETON-2 data will be presented at the European Respiratory Society Congress in Amsterdam on September 28, 2025.