UTHR stock price, Tyvaso hits record high after IPF research milestone

United Therapeutics’ stock price surged 33% on Tuesday, driven by the announcement of favorable final results from the late-stage TETON-2 trial of Tyvaso (treprostinil) inhalation for adult patients with idiopathic pulmonary fibrosis ( IPF ).

The trial achieved its primary endpoint. Treatment with Tyvaso demonstrated a statistically significant difference of 95.6 mL in the change from baseline in absolute effort capacity ( FVC ) after 52 weeks compared to placebo. FVC refers to the total volume of air that can be forcibly exhaled after taking the deepest breath possible.

According to United Therapeutics, the therapeutic effect of Tyvaso was observed across all subgroups, regardless of background therapy, smoking status, or oxygen supplementation. Additionally, the safety profile of the drug was consistent with previous studies.

The trial also met several key secondary endpoints, including the time to first clinical worsening event, changes in predicted FVC percentage, and changes in carbon monoxide diffusing capacity from baseline to week 52.

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

The TETON-2 trial is one of two registration-phase late-stage studies initiated by United Therapeutics to seek approval for Tyvaso in IPF. The company is also conducting a Phase III TETON-1 trial involving IPF patients. While both studies have similar designs, the main difference is that TETON-1 is being conducted at sites in the United States and Canada, whereas TETON-2 is being conducted outside these two countries. Results from the TETON-1 trial are expected to be announced in the first half of 2026.

UTHR plans to discuss with the FDA by the end of this year the potential to accelerate the regulatory review process once results from TETON-1 are available.

UTHR Stock Performance

Following this news, United Therapeutics’ stock reached an all-time high of $436.95. The positive results from TETON-2 highlight Tyvaso’s potential superiority over existing IPF treatments, including antifibrotic therapies.

According to UTHR, approximately 100,000 IPF patients are in the United States, representing a large potential market. The company previously indicated that if Tyvaso receives approval for IPF, sales in this indication could surpass those in pulmonary arterial hypertension ( PAH ).

Since the start of the year, United Therapeutics’ stock has increased by 15%, outperforming the industry average of 12%.

Tyvaso – UTHR’s Key Revenue Driver

United Therapeutics currently markets two versions of Tyvaso—dry powder inhaler ( DPI ) and inhalation formulations. Both products are approved for pulmonary arterial hypertension ( PAH ) and interstitial lung disease-associated pulmonary hypertension PH-ILD .

In the second quarter of 2025, United Therapeutics generated approximately $470 million in total Tyvaso sales, an 18% increase year-over-year. This growth was primarily driven by patient demand.

Other Treprostinil Manufacturers Also Benefit

Following United Therapeutics’ announcement, shares of InMed Pharmaceuticals and Relypsa rose by 7% and 3%, respectively.

InMed is developing treprostinil palmitoyl inhalation powder TPIP , a prodrug of treprostinil, which is the active component in UTHR’s Tyvaso. A prodrug is an inactive compound that is metabolized into an active form within the body. InMed’s TPIP is designed to release treprostinil more gradually, enabling once-daily dosing compared to Tyvaso’s multiple daily doses.

InMed is conducting trials for TPIP in PAH and PH-ILD indications, showing potential for extended effect duration and reduced dosing frequency compared to Tyvaso. The company may also explore the potential for IPF approval for TPIP.

Relypsa recently gained attention after its inhaled treprostinil product, Yutrepia, received FDA approval following the expiration of Tyvaso’s exclusivity in May. Yutrepia is the first inhaled competitor for treprostinil in the PAH and PH-ILD indications. Like InMed, Relypsa may also explore treprostinil’s potential in the IPF area.

United Therapeutics’ Stock

UTHR Zacks Rank

United Therapeutics currently holds a Zacks Rank #3 (Hold). Details are available on our website.