We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
UTHR Stock Rises 12.5% on Promising Data From TETON-1 Tyvaso Study
Read MoreHide Full Article
Key Takeaways
UTHR shares rose 12.5% after TETON-1 showed significant lung function improvement in IPF patients.
The study met its primary endpoint with 130.1 mL FVC gain and reduced risk of clinical worsening.
United Therapeutics plans an FDA filing by summer, backed by strong TETON-1 and TETON-2 results.
Shares of United Therapeutics (UTHR - Free Report) 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.
Image Source: Zacks Investment Research
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).
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%.
Zacks' 7 Best Strong Buy Stocks (New Research Report)
Valued at $99, click below to receive our just-released report
predicting the 7 stocks that will soar highest in the coming month.
View the Zacks #1 Rank List
Image: Bigstock
UTHR Stock Rises 12.5% on Promising Data From TETON-1 Tyvaso Study
Key Takeaways
Shares of United Therapeutics (UTHR - Free Report) 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.
Image Source: Zacks Investment Research
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 - Free Report) and Indivior Pharmaceuticals (INDV - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy), and ANI Pharmaceuticals (ANIP - Free Report) , 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%.