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United Therapeutics (UTHR) Initiates Tyvaso Study in IPF
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United Therapeutics Corporation (UTHR - Free Report) announced that it has started dosing participants in the phase III TETON 2 study, which will evaluate Tyvaso (treprostinil) in adult patients with idiopathic pulmonary fibrosis (IPF).
Tyvaso is already approved by the FDA as an inhalation solution and dry powder inhaler 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 United Therapeutics’ 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 registrational late-stage study initiated by management for Tyvaso in IPF. The study is a part of the broader TETON program evaluating Tyvaso as a treatment for IPF. The ongoing phase III TETON 1 study is evaluating Tyvaso in IPF indication.
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 the United States and Canada.
Shares of United Therapeutics have fallen 2.1% in the year so far compared with the industry’s 29.6% decline.
Image Source: Zacks Investment Research
Currently, United Therapeutics markets five drugs, out of which four of them target pulmonary arterial hypertension (PAH) indications. These four drugs constituted nearly 90% of company’s product revenues in second-quarter 2022. United Therapeutics’ PAH portfolio consists of Remodulin (injectable version), Orenitram (oral version), Tyvaso (inhaled 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.
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.
United Therapeutics currently carries a Zacks Rank #5 (Strong Sell). Some better-ranked stock in the overall healthcare sector includes Aerie Pharmaceuticals , Catalyst Pharmaceuticals (CPRX - Free Report) and Codiak BioSciences , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Aerie Pharmaceuticals’ 2022 loss per share have narrowed from $1.83 to $1.82. During the same period, the loss estimates per share for 2023 have narrowed from $1.01 to $0.96. Shares of Aerie Pharmaceuticals have gained 116.7% in the year-to-date period.
Earnings of Aerie Pharmaceuticals beat estimates in two of the last four quarters and missed the mark twice, witnessing a surprise of 70.27% on average. In the last reported quarter, AERI delivered an earnings surprise of 38.46%.
In the past 60 days, estimates for Catalyst Pharmaceuticals’ 2023 earnings per share have increased from $0.84 to $0.85. Shares of Catalyst Pharmaceuticals have surged 84.9% in the year-to-date period.
Earnings of Catalyst Pharmaceuticals beat estimates in one of the last four quarters, missed the mark on two occasions and met the mark just once, witnessing a negative surprise of 5.41% on average. In the last reported quarter, NVS delivered an earnings surprise of 17.65%.
In the past 60 days, estimates for Codiak BioSciences’ 2022 loss per share have narrowed from $1.94 to $1.81. During the same period, the loss estimates per share for 2023 have narrowed from $2.14 to $1.53. Shares of Codiak BioSciences have lost 93.9% in the year-to-date period.
Earnings of Codiak BioSciences beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 35.40% on average. In the last reported quarter, CDAK delivered an earnings surprise of 61.54%.
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United Therapeutics (UTHR) Initiates Tyvaso Study in IPF
United Therapeutics Corporation (UTHR - Free Report) announced that it has started dosing participants in the phase III TETON 2 study, which will evaluate Tyvaso (treprostinil) in adult patients with idiopathic pulmonary fibrosis (IPF).
Tyvaso is already approved by the FDA as an inhalation solution and dry powder inhaler 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 United Therapeutics’ 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 registrational late-stage study initiated by management for Tyvaso in IPF. The study is a part of the broader TETON program evaluating Tyvaso as a treatment for IPF. The ongoing phase III TETON 1 study is evaluating Tyvaso in IPF indication.
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 the United States and Canada.
Shares of United Therapeutics have fallen 2.1% in the year so far compared with the industry’s 29.6% decline.
Image Source: Zacks Investment Research
Currently, United Therapeutics markets five drugs, out of which four of them target pulmonary arterial hypertension (PAH) indications. These four drugs constituted nearly 90% of company’s product revenues in second-quarter 2022. United Therapeutics’ PAH portfolio consists of Remodulin (injectable version), Orenitram (oral version), Tyvaso (inhaled 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.
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.
United Therapeutics Corporation Price
United Therapeutics Corporation price | United Therapeutics Corporation Quote
Zacks Rank & Stocks to Consider
United Therapeutics currently carries a Zacks Rank #5 (Strong Sell). Some better-ranked stock in the overall healthcare sector includes Aerie Pharmaceuticals , Catalyst Pharmaceuticals (CPRX - Free Report) and Codiak BioSciences , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for Aerie Pharmaceuticals’ 2022 loss per share have narrowed from $1.83 to $1.82. During the same period, the loss estimates per share for 2023 have narrowed from $1.01 to $0.96. Shares of Aerie Pharmaceuticals have gained 116.7% in the year-to-date period.
Earnings of Aerie Pharmaceuticals beat estimates in two of the last four quarters and missed the mark twice, witnessing a surprise of 70.27% on average. In the last reported quarter, AERI delivered an earnings surprise of 38.46%.
In the past 60 days, estimates for Catalyst Pharmaceuticals’ 2023 earnings per share have increased from $0.84 to $0.85. Shares of Catalyst Pharmaceuticals have surged 84.9% in the year-to-date period.
Earnings of Catalyst Pharmaceuticals beat estimates in one of the last four quarters, missed the mark on two occasions and met the mark just once, witnessing a negative surprise of 5.41% on average. In the last reported quarter, NVS delivered an earnings surprise of 17.65%.
In the past 60 days, estimates for Codiak BioSciences’ 2022 loss per share have narrowed from $1.94 to $1.81. During the same period, the loss estimates per share for 2023 have narrowed from $2.14 to $1.53. Shares of Codiak BioSciences have lost 93.9% in the year-to-date period.
Earnings of Codiak BioSciences beat estimates in three of the last four quarters and missed the mark just once, witnessing a surprise of 35.40% on average. In the last reported quarter, CDAK delivered an earnings surprise of 61.54%.