08:27 AM EDT, 09/02/2025 (MT Newswires) -- United Therapeutics ( UTHR ) said Tuesday that a pivotal study evaluating its nebulized Tyvaso inhalation solution for idiopathic pulmonary fibrosis has met its primary efficacy endpoint.

The company said the treatment showed superiority over placebo in terms of absolute forced vital capacity by 95.6 mL from baseline to week 52 in patients with IPF.

The study also found statistically significant improvements in most secondary endpoints, the company said.

While not statistically significant, the company said both time to first acute exacerbation and overall survival at week 52 trended in favor of Tyvaso.

United Therapeutics ( UTHR ) said it plans to use the data from this study and another ongoing one to support a supplemental marketing application to the US Food and Drug Administration to expand Tyvaso's label to include IPF.

The company said it expects to meet with the FDA before year-end to discuss options for potentially accelerating the review process, adding that a second data readout for the same indication is expected in H1 of next year.

Shares of United Therapeutics ( UTHR ) were up more than 40% in recent Tuesday premarket activity.