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United Therapeutics (UTHR) Completes Enrolment in IPF Study
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United Therapeutics (UTHR - Free Report) announced full enrolment in the phase III TETON 2 study evaluating a nebulized version of Tyvaso (treprostinil) in patients with idiopathic pulmonary fibrosis (IPF), a scarring disease of the lungs.
The TETON 2 study is now enrolled with a total of 597 patients. Top-line data from this study is expected in second-half 2025.
The FDA has already approved Tyvaso as an inhalation solution (nebulized) and dry powder inhaler (DPI) for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The drug is currently the key revenue generator in UTHR’s portfolio of marketed drugs. The drug is yet to be approved by any regulatory authority worldwide for IPF indication.
The TETON 2 study is also the second late-stage study initiated by management for Tyvaso in IPF. It is a part of the broader TETON program evaluating Tyvaso as a treatment for IPF. The ongoing phase III TETON 1 study is evaluating nebulized Tyvaso in IPF indication. Enrolment in this study is currently ongoing.
Both the TETON 1 and TETON 2 studies are registrational late-stage studies that are parallel in design to each other. The only difference is that while the TETON 1 study is being conducted at sites located in the United States and Canada, the TETON 2 study is being conducted at sites outside these two countries.
Though the above studies evaluate a nebulized version of Tyvaso, management intends to seek label expansion for both nebulized and DPI formulations of the drug in IPF indication. The DPI version of Tyvaso requires less time to administer and is also more mobile and convenient than the nebulized version. In this regard, UTHR stated that it would be open to conducting ‘any FDA-required bridging studies.’
Per management, treatment with Tyvaso has demonstrated significant improvements in the rate of forced vital capacity (FVC), an established measure of lung function, in patients having an underlying etiology of IPF in previously conducted clinical studies. This also gives it an added advantage over the currently available IPF therapies — Boehringer Ingelheim’s Ofev and Roche’s Esbriet — both of which are only approved to slow the rate of disease progression.
If Tyvaso is approved in IPF indication, management expects the drug’s sales in IPF indication to outpace the drug’s sales in PAH indication.
Year to date, shares of United Therapeutics have surged 49.7% against the industry’s 7.3% decline.
Image Source: Zacks Investment Research
Currently, United Therapeutics markets five drugs, out of which four of them target PAH indications. Sales of these four drugs constituted over 90% of the company’s total revenues in the first quarter. Apart from Tyvaso, the company’s PAH portfolio consists of Remodulin (injectable version), Orenitram (oral version), and Adcirca tablets.
A market leader in PAH indication, UTHR depends on its PAH drugs to generate revenue and drive growth. This remains a concern as the company has now started facing challenges in marketing its PAH drugs, half of which are suffering due to rising generic competition in the United States. Considering these factors, management started working on expanded indications for its marketed products.
Last October, management expanded the TETON program for a condition similar to IPF called progressive pulmonary fibrosis (PPF). A late-stage study (called TETON PPF) is currently ongoing, which is evaluating nebulized Tyvaso in PPF patients.
Apart from product revenues, United Therapeutics is also engaged in research and development efforts to increase the supply of transplantable organs and tissues through regenerative medicine and organ manufacturing.
Zacks Rank & Stocks to Consider
United Therapeutics currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include Arcutis Biotherapeutics (ARQT - Free Report) , Compugen (CGEN - Free Report) and Heron Therapeutics (HRTX - Free Report) . While HRTX sports a Zacks Rank #1 (Strong Buy), ARQT and CGEN, each carry a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Heron Therapeutics’ 2024 loss per sharehave narrowed from 14 cents to 10 cents. During the same period, estimates for 2025 have improved from a loss of 2 cents to earnings of 1 cent. Year to date, HRTX’s shares have appreciated 78.8%.
Earnings of Heron Therapeutics beat estimates in three of the last four quarters while missing the mark on one occasion. HRTX delivered a four-quarter average earnings surprise of 30.33%.
In the past 60 days, estimates for Arcutis Biotherapeutics’ 2024 loss per share have narrowed from $2.22 to $1.60. During the same period, the loss estimates per share for 2025 have narrowed from $1.37 to $1.14. Year to date, shares of Arcutis have surged 203.7%.
Earnings of Arcutis Biotherapeutics beat estimates in three of the last four quarters while missing the mark on one occasion. Arcutis delivered a four-quarter average earnings surprise of 14.93%.
In the past 60 days, estimates for Compugen’s 2024 earnings per sharehave risen from 2 cents to 5 cents. During the same period, loss estimates per share for 2025 have improved from 27 cents to 11 cents. Year to date, CGEN’s shares have lost 13.1%.
Earnings of Compugen beat estimates in three of the last four quarters while missing the mark on one occasion. CGEN delivered a four-quarter average earnings surprise of 5.79%.
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United Therapeutics (UTHR) Completes Enrolment in IPF Study
United Therapeutics (UTHR - Free Report) announced full enrolment in the phase III TETON 2 study evaluating a nebulized version of Tyvaso (treprostinil) in patients with idiopathic pulmonary fibrosis (IPF), a scarring disease of the lungs.
The TETON 2 study is now enrolled with a total of 597 patients. Top-line data from this study is expected in second-half 2025.
The FDA has already approved Tyvaso as an inhalation solution (nebulized) and dry powder inhaler (DPI) for treating pulmonary arterial hypertension (PAH) and pulmonary hypertension associated with interstitial lung disease (PH-ILD). The drug is currently the key revenue generator in UTHR’s portfolio of marketed drugs. The drug is yet to be approved by any regulatory authority worldwide for IPF indication.
The TETON 2 study is also the second late-stage study initiated by management for Tyvaso in IPF. It is a part of the broader TETON program evaluating Tyvaso as a treatment for IPF. The ongoing phase III TETON 1 study is evaluating nebulized Tyvaso in IPF indication. Enrolment in this study is currently ongoing.
Both the TETON 1 and TETON 2 studies are registrational late-stage studies that are parallel in design to each other. The only difference is that while the TETON 1 study is being conducted at sites located in the United States and Canada, the TETON 2 study is being conducted at sites outside these two countries.
Though the above studies evaluate a nebulized version of Tyvaso, management intends to seek label expansion for both nebulized and DPI formulations of the drug in IPF indication. The DPI version of Tyvaso requires less time to administer and is also more mobile and convenient than the nebulized version. In this regard, UTHR stated that it would be open to conducting ‘any FDA-required bridging studies.’
Per management, treatment with Tyvaso has demonstrated significant improvements in the rate of forced vital capacity (FVC), an established measure of lung function, in patients having an underlying etiology of IPF in previously conducted clinical studies. This also gives it an added advantage over the currently available IPF therapies — Boehringer Ingelheim’s Ofev and Roche’s Esbriet — both of which are only approved to slow the rate of disease progression.
If Tyvaso is approved in IPF indication, management expects the drug’s sales in IPF indication to outpace the drug’s sales in PAH indication.
Year to date, shares of United Therapeutics have surged 49.7% against the industry’s 7.3% decline.
Image Source: Zacks Investment Research
Currently, United Therapeutics markets five drugs, out of which four of them target PAH indications. Sales of these four drugs constituted over 90% of the company’s total revenues in the first quarter. Apart from Tyvaso, the company’s PAH portfolio consists of Remodulin (injectable version), Orenitram (oral version), and Adcirca tablets.
A market leader in PAH indication, UTHR depends on its PAH drugs to generate revenue and drive growth. This remains a concern as the company has now started facing challenges in marketing its PAH drugs, half of which are suffering due to rising generic competition in the United States. Considering these factors, management started working on expanded indications for its marketed products.
Last October, management expanded the TETON program for a condition similar to IPF called progressive pulmonary fibrosis (PPF). A late-stage study (called TETON PPF) is currently ongoing, which is evaluating nebulized Tyvaso in PPF patients.
Apart from product revenues, United Therapeutics is also engaged in research and development efforts to increase the supply of transplantable organs and tissues through regenerative medicine and organ manufacturing.
Zacks Rank & Stocks to Consider
United Therapeutics currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include Arcutis Biotherapeutics (ARQT - Free Report) , Compugen (CGEN - Free Report) and Heron Therapeutics (HRTX - Free Report) . While HRTX sports a Zacks Rank #1 (Strong Buy), ARQT and CGEN, each carry a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Heron Therapeutics’ 2024 loss per sharehave narrowed from 14 cents to 10 cents. During the same period, estimates for 2025 have improved from a loss of 2 cents to earnings of 1 cent. Year to date, HRTX’s shares have appreciated 78.8%.
Earnings of Heron Therapeutics beat estimates in three of the last four quarters while missing the mark on one occasion. HRTX delivered a four-quarter average earnings surprise of 30.33%.
In the past 60 days, estimates for Arcutis Biotherapeutics’ 2024 loss per share have narrowed from $2.22 to $1.60. During the same period, the loss estimates per share for 2025 have narrowed from $1.37 to $1.14. Year to date, shares of Arcutis have surged 203.7%.
Earnings of Arcutis Biotherapeutics beat estimates in three of the last four quarters while missing the mark on one occasion. Arcutis delivered a four-quarter average earnings surprise of 14.93%.
In the past 60 days, estimates for Compugen’s 2024 earnings per sharehave risen from 2 cents to 5 cents. During the same period, loss estimates per share for 2025 have improved from 27 cents to 11 cents. Year to date, CGEN’s shares have lost 13.1%.
Earnings of Compugen beat estimates in three of the last four quarters while missing the mark on one occasion. CGEN delivered a four-quarter average earnings surprise of 5.79%.