United Therapeutics Announces Full Enrollment Of TETON-PPF Study Evaluating Use Of Tyvaso Inhalation Solution For Treatment Of Progressive Pulmonary Fibrosis; Topline Data Expected In H2 Of 2027

FDA Accepts UTHR's sNDA for Tyvaso in Idiopathic Pulmonary Fibrosis

United Therapeutics announced FDA acceptance of a supplemental new drug application for nebulized Tyvaso to treat idiopathic pulmonary fibrosis (IPF), with a regulatory decision expected in late April 2027. The TETON phase III studies demonstrated statistically significant improvements in lung function, including a 111.8 mL FVC benefit, reduced clinical worsening, and favorable secondary endpoints. If approved, Tyvaso would be the first FDA-approved inhaled anti-fibrotic treatment for IPF.

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United Therapeutics shares are trading lower. The company announced the FDA acceptance of its sNDA for nebulized Tyvaso Inhalation Solution to treat idiopathic pulmonary fibrosis.

United Therapeutics Says FDA Accepts sNDA For Nebulized Tyvaso Inhalation Solution To Treat IPF

Nebulized Tyvaso® (treprostinil) Inhalation Solution will be the first and only inhaled anti-fibrotic treatment for idiopathic pulmonary fibrosis (IPF) if approved by the U.S. Food and Drug Administration (FDA)United