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UTHR Completes Phase III Tyvaso Study Enrollment for Expanded Label
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Key Takeaways
United Therapeutics enrolled 754 PPF patients in the 52-week TETON-PPF Phase III study.
The study's primary endpoint is the change in absolute FVC from baseline through week 52.
Positive results could support an FDA filing to add PPF to Tyvaso's labeled indications.
United Therapeutics (UTHR - Free Report) announced completing enrollment in the phase III TETON-PPF study evaluating Tyvaso (treprostinil) inhalation solution for the treatment of progressive pulmonary fibrosis (PPF). The global registrational study is designed to assess the safety and efficacy of nebulized Tyvaso in this patient population over 52 weeks. Per UTHR, PPF is a progressive form of interstitial lung disease (ILD) marked by worsening lung function and fibrosis, with approximately 200,000 patients estimated to be affected in the United States.
United Therapeutics’ Tyvaso is already approved for two indications. It is indicated to improve exercise ability in patients with pulmonary arterial hypertension (PAH; WHO Group 1) and in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3). However, its use in PPF remains investigational, and the FDA has not approved nebulized Tyvaso for this indication.
UTHR’s Phase III PPF Study Design in Detail
United Therapeutics’ phase III TETON-PPF placebo-controlled study has enrolled 754 PPF patients who were randomly assigned in a 1:1 ratio to receive either nebulized Tyvaso or placebo. Treatment began at three breaths four times daily and was gradually increased, as tolerated, toward a target of 12 breaths four times daily. The treatment period will run for 52 weeks, with patients who complete the final study visit potentially eligible for an open-label extension.
Year to date, shares of United Therapeutics have gained 4.3% against the industry’s 1.1% decline.
Image Source: Zacks Investment Research
The primary endpoint is the change in absolute forced vital capacity (FVC) from baseline through week 52, which is intended to measure the treatment’s effect on lung function. Secondary endpoints include time to first clinical worsening, time to first acute exacerbation of ILD, overall survival at week 52, change in percent predicted FVC, change in the King’s Brief Interstitial Lung Disease questionnaire score and change in diffusing capacity of the lungs for carbon monoxide.
The study is also collecting data on N-terminal pro-brain natriuretic peptide levels and supplemental oxygen use, while safety assessments cover adverse events, laboratory measures, vital signs and electrocardiograms.
UTHR’s Next Steps
Having completed enrollment in the phase III study evaluating Tyvaso, United Therapeutics expects to report top-line results in the second half of 2027. The readout will be an important milestone for UTHR, as positive results could expand access to a potential new treatment option for patients with PPF, who currently have limited therapies available and face progressive loss of lung function, poorer quality of life and increased mortality.
Subject to the success of the TETON-PPF study, United Therapeutics plans to use the data to support a supplemental new drug application (sNDA) with the FDA to add PPF to the labeled indications for nebulized Tyvaso.
Separately, UTHR is already seeking priority review for an sNDA submitted to the FDA in June 2026 to add idiopathic pulmonary fibrosis to the labeled indications for nebulized Tyvaso, based on data from the TETON-1 and TETON-2 studies.
Under the FDA’s Priority Review pathway, the agency aims to take action on an eligible marketing application within six months compared with 10 months under standard review. Priority Review is generally granted to applications for drugs that treat serious conditions and, if approved, would provide a significant improvement in the safety or effectiveness of treatment, diagnosis or prevention.
United Therapeutics Corporation Price and Consensus
Over the past 60 days, earnings estimates for Amneal Pharmaceuticals have increased from $1.00 to $1.02 for 2026. Over the same period, earnings estimates increased from $1.12 to $1.21 for 2027. AMRX shares have risen 46.1% year to date.
Amneal Pharmaceuticals beat earnings in each of the trailing four quarters, delivering an average surprise of 32.82%.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61. RGEN shares have gained 3.2% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU shares have plunged 19.4% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
View the Zacks #1 Rank List
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UTHR Completes Phase III Tyvaso Study Enrollment for Expanded Label
Key Takeaways
United Therapeutics (UTHR - Free Report) announced completing enrollment in the phase III TETON-PPF study evaluating Tyvaso (treprostinil) inhalation solution for the treatment of progressive pulmonary fibrosis (PPF). The global registrational study is designed to assess the safety and efficacy of nebulized Tyvaso in this patient population over 52 weeks. Per UTHR, PPF is a progressive form of interstitial lung disease (ILD) marked by worsening lung function and fibrosis, with approximately 200,000 patients estimated to be affected in the United States.
United Therapeutics’ Tyvaso is already approved for two indications. It is indicated to improve exercise ability in patients with pulmonary arterial hypertension (PAH; WHO Group 1) and in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD; WHO Group 3). However, its use in PPF remains investigational, and the FDA has not approved nebulized Tyvaso for this indication.
UTHR’s Phase III PPF Study Design in Detail
United Therapeutics’ phase III TETON-PPF placebo-controlled study has enrolled 754 PPF patients who were randomly assigned in a 1:1 ratio to receive either nebulized Tyvaso or placebo. Treatment began at three breaths four times daily and was gradually increased, as tolerated, toward a target of 12 breaths four times daily. The treatment period will run for 52 weeks, with patients who complete the final study visit potentially eligible for an open-label extension.
Year to date, shares of United Therapeutics have gained 4.3% against the industry’s 1.1% decline.
Image Source: Zacks Investment Research
The primary endpoint is the change in absolute forced vital capacity (FVC) from baseline through week 52, which is intended to measure the treatment’s effect on lung function. Secondary endpoints include time to first clinical worsening, time to first acute exacerbation of ILD, overall survival at week 52, change in percent predicted FVC, change in the King’s Brief Interstitial Lung Disease questionnaire score and change in diffusing capacity of the lungs for carbon monoxide.
The study is also collecting data on N-terminal pro-brain natriuretic peptide levels and supplemental oxygen use, while safety assessments cover adverse events, laboratory measures, vital signs and electrocardiograms.
UTHR’s Next Steps
Having completed enrollment in the phase III study evaluating Tyvaso, United Therapeutics expects to report top-line results in the second half of 2027. The readout will be an important milestone for UTHR, as positive results could expand access to a potential new treatment option for patients with PPF, who currently have limited therapies available and face progressive loss of lung function, poorer quality of life and increased mortality.
Subject to the success of the TETON-PPF study, United Therapeutics plans to use the data to support a supplemental new drug application (sNDA) with the FDA to add PPF to the labeled indications for nebulized Tyvaso.
Separately, UTHR is already seeking priority review for an sNDA submitted to the FDA in June 2026 to add idiopathic pulmonary fibrosis to the labeled indications for nebulized Tyvaso, based on data from the TETON-1 and TETON-2 studies.
Under the FDA’s Priority Review pathway, the agency aims to take action on an eligible marketing application within six months compared with 10 months under standard review. Priority Review is generally granted to applications for drugs that treat serious conditions and, if approved, would provide a significant improvement in the safety or effectiveness of treatment, diagnosis or prevention.
United Therapeutics Corporation Price and Consensus
United Therapeutics Corporation price-consensus-chart | United Therapeutics Corporation Quote
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 Amneal Pharmaceuticals (AMRX - Free Report) , Repligen (RGEN - Free Report) and AC Immune (ACIU - Free Report) . AMRX and RGEN currently sport a Zacks Rank #1 (Strong Buy) each, while ACIU 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, earnings estimates for Amneal Pharmaceuticals have increased from $1.00 to $1.02 for 2026. Over the same period, earnings estimates increased from $1.12 to $1.21 for 2027. AMRX shares have risen 46.1% year to date.
Amneal Pharmaceuticals beat earnings in each of the trailing four quarters, delivering an average surprise of 32.82%.
Over the past 60 days, estimates for Repligen’s 2026 earnings per share have risen from $1.99 to $2.06, while estimates for 2027 have increased from $2.57 to $2.61. RGEN shares have gained 3.2% year to date.
Repligen’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 16.80%.
Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU shares have plunged 19.4% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.