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Merck Stock Worth Watching on PAH Drug Winrevair's Approval in Europe?
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Merck (MRK - Free Report) announced that the European Commission has granted approval to its novel activin signaling inhibitor, Winrevair (sotatercept), for treating adult patients with pulmonary arterial hypertension (PAH). Winrevair can now be prescribed to treat PAH in adult patients with World Health Organization (WHO) Functional Class (FC) II to III in the EU in combination with other PAH therapies. Winrevair becomes the first novel activin signaling inhibitor therapy approved in Europe to treat PAH.
The approval was based on data from the STELLAR study. In the study, Winrevair plus background therapy significantly improved exercise capacity, increasing the six-minute walk distance by 40.8 meters from baseline at week 24, the study’s primary endpoint. Moreover, Winrevair demonstrated statistically significant improvements in eight out of nine secondary outcome measures, including a reduction in the risk of clinical worsening or death.
Winrevair was approved by the FDA to treat PAH, WHO Group 1 in March this year.
Merck’s stock has risen 6.7% so far this year compared with an increase of 27.4% for the industry.
Image Source: Zacks Investment Research
PAH is a rare, progressive blood vessel disorder that affects the blood vessel walls in the lungs, resulting in elevated blood pressure. It exerts significant strain on the heart, as it works harder to pump blood through the lungs, eventually leading to heart failure if left untreated.
Winrevair is designed to target cellular signaling associated with vascular hyperproliferation and pathological remodeling to treat PAH. Winrevair works by blocking the proteins that contribute to the thickening of blood vessel walls in the lung.
MRK Pins Hopes on Winrevair Ahead of Keytruda’s Loss of Patent
In the second quarter, Winrevair recorded sales of $70 million from the U.S. market. On the conference call, the company said that the U.S. launch of the drug is progressing well. Approximately 40% of sales were due to doses administered to patients and the remainder were due to inventory building. Sales were above investor expectations. The approval in Europe should boost sales further in the second half of the year. Merck believes that Winrevair has the potential to generate significant revenues over the long term. Merck is pinning hopes on Winrevair to boost its top line once its blockbuster drug, Keytruda loses patent exclusivity in 2028.
Merck is also evaluating sotatercept in patients with more advanced disease in the phase III ZENITH and HYPERION studies.
Merck added Winrevair following its $11 billion acquisition of Acceleron Pharma in 2021.
Other Players in PAH Market
Significant players in the PAH market are United Therapeutics (UTHR - Free Report) and Johnson & Johnson (JNJ - Free Report) . United Therapeutics markets four drugs to treat PAH in the United States — Remodulin, Orenitram, Tyvaso and Adcirca.
Remodulin is an injectable formulation of treprostinil. Orenitram is an oral version of treprostinil, while Tyvaso is an inhaled version of Treprostinil. Remodulin, Orenitram and Tyvaso recorded sales of $275.3 million, $213.3 million and $770.7 million, respectively, in the first half of 2024.
As far as J&J is concerned, the PAH franchise was added to its portfolio with the 2017 acquisition of Actelion. J&J’s key PAH drugs are Opsumit and Uptravi. J&J recorded revenues of $2.09 billion from its PAH franchise in the first half of 2024, up 13.2% year over year.
Estimates for Lilly’s 2024 earnings have risen from $13.76 to $15.77 per share over the past 30 days. For 2025, earnings estimates have risen from $19.44 to $22.79 per share over the same timeframe. Year to date, Lilly’s stock has risen 63.1%.
Lilly beat estimates in each of the last four quarters, delivering a four-quarter average earnings surprise of 69.07%.
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Merck Stock Worth Watching on PAH Drug Winrevair's Approval in Europe?
Merck (MRK - Free Report) announced that the European Commission has granted approval to its novel activin signaling inhibitor, Winrevair (sotatercept), for treating adult patients with pulmonary arterial hypertension (PAH). Winrevair can now be prescribed to treat PAH in adult patients with World Health Organization (WHO) Functional Class (FC) II to III in the EU in combination with other PAH therapies. Winrevair becomes the first novel activin signaling inhibitor therapy approved in Europe to treat PAH.
The approval was based on data from the STELLAR study. In the study, Winrevair plus background therapy significantly improved exercise capacity, increasing the six-minute walk distance by 40.8 meters from baseline at week 24, the study’s primary endpoint. Moreover, Winrevair demonstrated statistically significant improvements in eight out of nine secondary outcome measures, including a reduction in the risk of clinical worsening or death.
Winrevair was approved by the FDA to treat PAH, WHO Group 1 in March this year.
Merck’s stock has risen 6.7% so far this year compared with an increase of 27.4% for the industry.
Image Source: Zacks Investment Research
PAH is a rare, progressive blood vessel disorder that affects the blood vessel walls in the lungs, resulting in elevated blood pressure. It exerts significant strain on the heart, as it works harder to pump blood through the lungs, eventually leading to heart failure if left untreated.
Winrevair is designed to target cellular signaling associated with vascular hyperproliferation and pathological remodeling to treat PAH. Winrevair works by blocking the proteins that contribute to the thickening of blood vessel walls in the lung.
MRK Pins Hopes on Winrevair Ahead of Keytruda’s Loss of Patent
In the second quarter, Winrevair recorded sales of $70 million from the U.S. market. On the conference call, the company said that the U.S. launch of the drug is progressing well. Approximately 40% of sales were due to doses administered to patients and the remainder were due to inventory building. Sales were above investor expectations. The approval in Europe should boost sales further in the second half of the year. Merck believes that Winrevair has the potential to generate significant revenues over the long term. Merck is pinning hopes on Winrevair to boost its top line once its blockbuster drug, Keytruda loses patent exclusivity in 2028.
Merck is also evaluating sotatercept in patients with more advanced disease in the phase III ZENITH and HYPERION studies.
Merck added Winrevair following its $11 billion acquisition of Acceleron Pharma in 2021.
Other Players in PAH Market
Significant players in the PAH market are United Therapeutics (UTHR - Free Report) and Johnson & Johnson (JNJ - Free Report) . United Therapeutics markets four drugs to treat PAH in the United States — Remodulin, Orenitram, Tyvaso and Adcirca.
Remodulin is an injectable formulation of treprostinil. Orenitram is an oral version of treprostinil, while Tyvaso is an inhaled version of Treprostinil. Remodulin, Orenitram and Tyvaso recorded sales of $275.3 million, $213.3 million and $770.7 million, respectively, in the first half of 2024.
As far as J&J is concerned, the PAH franchise was added to its portfolio with the 2017 acquisition of Actelion. J&J’s key PAH drugs are Opsumit and Uptravi. J&J recorded revenues of $2.09 billion from its PAH franchise in the first half of 2024, up 13.2% year over year.
Zacks Rank & Stock to Consider
Merck has a Zacks Rank #3 (Hold) currently.
Merck & Co., Inc. Price and Consensus
Merck & Co., Inc. price-consensus-chart | Merck & Co., Inc. Quote
A top-ranked stock large drugmaker is Eli Lilly (LLY - Free Report) , carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Estimates for Lilly’s 2024 earnings have risen from $13.76 to $15.77 per share over the past 30 days. For 2025, earnings estimates have risen from $19.44 to $22.79 per share over the same timeframe. Year to date, Lilly’s stock has risen 63.1%.
Lilly beat estimates in each of the last four quarters, delivering a four-quarter average earnings surprise of 69.07%.