Shares of United Therapeutics (NASDAQ:UTHR) jumped 54% following news that the company’s pivotal TETON-2 trial of Tyvaso for idiopathic pulmonary fibrosis (IPF) successfully achieved its primary endpoint.
The study found that nebulized Tyvaso (treprostinil) Inhalation Solution significantly outperformed placebo, improving absolute forced vital capacity (FVC) by 95.6 mL (p<0.001). The treatment also demonstrated statistically significant benefits across most secondary endpoints, including time to first clinical worsening event and measures of quality of life.
United Therapeutics plans to leverage results from both TETON-2 and the ongoing TETON-1 trial to support a supplemental New Drug Application (sNDA) with the FDA, aiming to expand Tyvaso’s approved use to include IPF. The company intends to meet with the FDA before the end of the year to discuss a potential expedited review once TETON-1 results are released, expected in the first half of 2026.
“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.
Treprostinil has received orphan drug designation from both the FDA and the European Medicines Agency for treating IPF, a progressive lung condition with limited therapeutic options. Additional findings from TETON-2 will be presented at the European Respiratory Society Congress in Amsterdam on September 28, 2025.
United Therapeutics Corporation stock price
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