UTHR Stock Hits Record High on Tyvaso Meeting IPF Study Goals

Shares of United Therapeutics UTHR surged 33% on Tuesday after it announced positive top-line results from the late-stage TETON-2 study evaluating the nebulized version of Tyvaso (treprostinil) in adult patients with idiopathic pulmonary fibrosis (IPF).

The study met its primary endpoint — treatment with Tyvaso showed superiority over placebo for the change in absolute forced vital capacity (FVC) by 95.6 mL after 52 weeks. FVC refers to the total amount of air a person can forcibly exhale after taking the deepest breath possible.

Per United Therapeutics, the benefits of treatment with Tyvaso were observed across all subgroups, regardless of the use of background therapy, smoking status and supplemental oxygen. The safety profile of the drug was also consistent with previous studies on the drug.

The study also met several key secondary endpoints, including time to first clinical worsening event, changes from baseline to week 52 in percent predicted FVC and diffusion capacity of lungs for carbon monoxide.

IPF is a chronic, scarring disease characterized by progressive loss of the lungs’ ability to transfer oxygen into the blood, ultimately leading to respiratory failure and death.

The TETON 2 study is one of the two registrational, late-stage studies initiated by United Therapeutics for Tyvaso in IPF. The company is also conducting the phase III TETON-1 study of nebulized Tyvaso in IPF patients. Though both studies are parallel in design, the only difference is that the TETON-1 study is being conducted at sites located in the United States and Canada, while the TETON-2 study was conducted at sites outside these two countries. A data readout from the TETON-1 study is expected in the first half of 2026.

UTHR plans to meet with the FDA before this year’s end to potentially expedite the regulatory review process once the TETON-1 results are available.

UTHR Stock Performance

Following the news, shares of United Therapeutics hit an all-time high of $436.95. The encouraging results of the TETON-2 study highlight the superiority of Tyvaso over the existing IPF treatments, including the current standard of care anti-fibrotic therapy.

Per UTHR, about 100,000 IPF patients are living in the United States, presenting access to a substantial untapped market with blockbuster potential. The company had previously pointed out that if Tyvaso were approved in the IPF indication, sales in the IPF indication have the potential to exceed the drug’s sales in the PAH indication.

Year to date, shares of United Therapeutics have risen 15% compared with the industry’s 12% growth.

Tyvaso – A Key Driver of UTHR’s Top Line

United Therapeutics currently markets two versions of Tyvaso — a dry powder inhalation (DPI) formulation and a nebulized version. Both products are approved for treating PAH and pulmonary hypertension associated with interstitial lung disease (PH-ILD) indications.

During the second quarter of 2025, United Therapeutics generated nearly $470 million from overall Tyvaso product sales, up 18% year over year. This growth was primarily driven by patient demand.

UTHR’s Gains Also Enjoyed by Other Treprostinil Makers

Post United Therapeutics’ results announcement, shares of Insmed INSM and Liquidia Corporation LQDA also rose 7% and 3%, respectively.

Insmed is developing treprostinil palmitil inhalation powder (TPIP), which is a prodrug of UTHR’s treprostinil, the active ingredient in the Tyvaso products. A prodrug is an inactive compound that becomes active once inside the body, allowing Insmed’s TPIP to release treprostinil more gradually. This extended-release design enables once-daily dosing, compared to Tyvaso, which requires multiple daily doses using either a nebulizer or a DPI.

Insmed has previously reported encouraging results from separate mid-stage studies on TPIP for PAH and PH-ILD indications, demonstrating the potential to prolong the duration of effect and reduce dose frequency compared to Tyvaso products. INSM could likely explore the potential of TPIP in the IPF indication.

Liquidia recently made headlines when it secured the FDA approval for an inhaled treprostinil product called Yutrepia after Tyvaso lost exclusivity in May. Yutrepia marked the first inhaled competitor for both PAH and PH-ILD indications. Like Insmed, Liquidia could also explore its treprostinil drug’s potential in the IPF space.

United Therapeutics Corporation Price

 

United Therapeutics Corporation price | United Therapeutics Corporation Quote

UTHR’s Zacks Rank

United Therapeutics currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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