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Investing.com -- United Therapeutics (NASDAQ:UTHR) stock rose 54% after the company announced that its TETON-2 pivotal study of Tyvaso for the treatment of idiopathic pulmonary fibrosis (IPF) met its primary efficacy endpoint.
The study demonstrated that nebulized Tyvaso (treprostinil) Inhalation Solution showed superiority over placebo for the change in absolute forced vital capacity (FVC) by 95.6 mL, a statistically significant improvement (p<0.001). The treatment also showed statistically significant improvements in most secondary endpoints, including time to first clinical worsening event and quality of life measures.
United Therapeutics plans to use data from both the TETON-2 study and the ongoing TETON-1 study to support a supplemental New Drug Application to the FDA to add IPF to Tyvaso’s labeled indications. The company intends to meet with the FDA before year-end to discuss expediting the regulatory review process when TETON-1 results become available, which is 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.
Both the FDA and European Medicines Agency have granted orphan designation for treprostinil to treat IPF, a chronic lung disease with limited treatment options. The company plans to present additional TETON-2 study results at the European Respiratory Society Congress in Amsterdam on September 28, 2025.
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