UTHR Stock Rises 12.5% on Promising Data From TETON-1 Tyvaso Study

Shares of United Therapeutics UTHR rallied 12.5% on Monday after the company unveiled robust data from the phase III TETON-1 study evaluating nebulized Tyvaso for the treatment of patients with idiopathic pulmonary fibrosis (IPF), a devastating lung disease with limited treatment options.

UTHR’s TETON program comprises two late-stage parallel studies—TETON-1 conducted in the United States and Canada, and TETON-2 internationally—with top-line data from TETON-2 previously reported in September 2025.

IPF is a chronic, progressive lung disease in which the lung tissue becomes scarred (fibrotic) for unknown reasons, making it increasingly difficult for the lungs to transfer oxygen into the bloodstream.

Year to date, UTHR’s shares have risen 20.8% against the industry’s 4.3% decline.

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Key Details of UTHR’s Phase III TETON-1 Study

The late-stage TETON-1 study demonstrated a statistically significant improvement in lung function for IPF patients, with a 130.1 mL increase in forced vital capacity (FVC) at 52 weeks from baseline versus placebo. The study successfully met its primary endpoint.

The therapy also significantly reduced the risk of clinical worsening and showed favorable trends across key secondary endpoints, including delayed time to first acute IPF exacerbation, changes in percent predicted FVC from baseline to week 52, King’s Brief Interstitial Lung Disease quality of life questionnaire score and diffusion capacity of the lungs for carbon monoxide.

Nebulized Tyvaso demonstrated consistent benefits across all patient subgroups regardless of background therapy use, smoking status and supplemental oxygen. The safety profile was in line with prior studies and no new safety concerns were observed.

Per management, the exceptional TETON-1 study data surpassed the strong outcomes from the TETON-2 study of Tyvaso, marking a significant advancement for patients with IPF.

Integrated analyses of both studies further reinforced these findings, showing a 111.8 mL FVC benefit and broad secondary endpoint improvements, although overall survival did not reach statistical significance.

United Therapeutics already markets two versions of Tyvaso — Tyvaso dry powder inhalation and nebulized Tyvaso. Both versions are approved for the treatment of pulmonary arterial hypertension and pulmonary hypertension associated with interstitial lung disease.

Based on data from the TETON-1 and TETON-2 studies, United Therapeutics intends to submit a supplemental new drug application to the FDA by the end of summer, seeking priority review for the approval of nebulized Tyvaso in IPF.

Besides IPF, UTHR is also conducting a phase III TETON PPF study to evaluate the therapy in progressive pulmonary fibrosis. Eligible patients who completed the TETON-1 study could enroll in TETON-OLE, an ongoing open-label extension study assessing the long-term safety and tolerability of nebulized Tyvaso in fibrotic lung disease.

UTHR's Zacks Rank & Stocks to Consider

United Therapeutics currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Catalyst Pharmaceuticals CPRX and Indivior Pharmaceuticals INDV, each currently sporting a Zacks Rank #1 (Strong Buy), and ANI Pharmaceuticals ANIP, which presently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

Over the past 60 days, estimates for Catalyst Pharmaceuticals’ 2026 earnings per share have risen from $2.55 to $2.87. CPRX shares have lost 0.6% over the past year.

Catalyst Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 35.19%.

Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have risen from $2.89 to $3.08. INDV shares have surged 206.8% over the past year.

Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 74.53%.

Over the past 60 days, estimates for ANI Pharmaceuticals’ earnings per share have increased from $8.28 to $8.99 for 2026. Over the past year, shares of ANIP have rallied 8.4%.

ANI Pharmaceuticals' earnings beat estimates in each of the trailing four quarters, with the average surprise being 22.21%.

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