- Nebulized Tyvaso improved absolute forced vital capacity (FVC) by 130.1 mL over placebo.
- Consistent benefits were observed across patient subgroups regardless of background therapy, smoking status, or supplemental oxygen use.
- Integrated analyses combining TETON-1 and TETON-2 reinforced Tyvaso’s effectiveness, showing a 111.8 mL FVC improvement.
United Therapeutics Corp. (UTHR) announced on Monday that its TETON-1 trial of nebulized Tyvaso in the treatment of idiopathic pulmonary fibrosis (IPF) achieved its primary goal.
The treatment not only met its main efficacy endpoint but also reduced the risk of clinical worsening.
Nebulized Tyvaso Shows Broad Efficacy
The therapy demonstrated improvement in absolute forced vital capacity (FVC), outperforming placebo by 130.1 mL from baseline to week 52, giving new hope for patients with the debilitating lung disease.
Benefits were consistent across subgroups, regardless of background therapy, smoking status, or supplemental oxygen use, while safety profiles aligned with previous Tyvaso studies, with no new adverse signals observed.
“The unprecedented results of TETON-1, which surpassed even the overwhelmingly positive results of TETON-2, represent a profound step forward for people living with IPF, a devastating disease with few treatment options.”
-Martine Rothblatt, Chairperson and CEO, United Therapeutics
Following the update, United Therapeutics’ stock traded over 19% higher in Monday’s premarket. On Stocktwits, retail sentiment around the stock jumped to ‘bullish’ from ‘bearish’ territory the previous day. Message volume flipped to ‘high’ from ‘low’ levels in 24 hours.
Integrated Analyses Strengthen Findings
Combining data from TETON-1 and TETON-2 reinforced the therapy’s effectiveness, showing an improvement of 111.8 mL in FVC and consistent positive effects across most secondary endpoints.
Overall survival trends favored Tyvaso. Following these results, United Therapeutics intends to submit a supplemental New Drug Application to the U.S. Food and Drug Administration (FDA) by the end of summer 2026, seeking priority review to expand nebulized Tyvaso’s labeled indication to include IPF.
UTHR stock has gained over 7% year-to-date.
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