We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
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.
Merck’s (MRK - Free Report) phase III study called ZENITH evaluating its pulmonary arterial hypertension (“PAH”) drug, Winrevair (sotatercept), for more advanced disease, met its primary endpoint.
The ZENITH study evaluated Winrevair, a novel activin signaling inhibitor, in patients with PAH, WHO Group 1 functional class (FC) III or IV at high risk of mortality. The study’s primary endpoint was time to first morbidity or mortality event, which could be either all-cause death, lung transplantation, or PAH hospitalizations.
Top-line data from the study showed that treatment with Winrevair added to background PAH therapy, leading to a statistically significant and clinically meaningful reduction in the risk of morbidity or mortality events compared to placebo. Based on the overwhelming efficacy seen in the study, an independent data monitoring committee (DMC) recommended the study be stopped early. The DMC also recommended that patients with this advanced form of PAH be offered the opportunity to get Winrevair through an open-label extension study.
Merck’s stock rose 2% on Monday as the positive data can potentially help expand the drug’s patient population.
So far this year, Merck’s stock has declined 7% against an increase of 5.7% for the industry.
Image Source: Zacks Investment Research
How Does MRK’s Winrevair Treat PAH?
Winrevair was approved to treat PAH WHO Group 1 in the United States in March based on data from the STELLAR study. It was approved for similar use in the EU in August 2024.
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.
Merck is also evaluating Winrevair in another phase III study called HYPERION in newly diagnosed intermediate- and high-risk PAH patients.
MRK Pins Hopes on Winrevair Ahead of Keytruda’s Loss of Patent
Winrevair is already seeing a strong launch, generating sales of $219 million this year. On the third-quarter conference call in October, the company said that the U.S. launch of the drug is gaining momentum, and the company is steadily adding new patients. More than 2,600 new commercial patients have started treatment since launch.
In EU, Merck has launched Winrevair in Germany. It expects to obtain reimbursement for Winrevair in most other European markets, which typically takes 12 months, by the second half of 2025.
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 added Winrevair following its $11 billion acquisition of Acceleron Pharma in 2021.
Other Players in the 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 $403.6 million, $326.5 million and $1.2 billion, 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 $3.19 billion from its PAH franchise in the first nine months of 2024, up 14% year over year.
The Zacks Consensus Estimate for Pfizer’s earnings has risen from $2.67 to $2.91 per share for 2024 over the past 60 days, while that for 2025 has risen from $2.86 to $2.92. Pfizer’s shares have lost 9.1% year to date.
Pfizer beat on earnings in each of the trailing four quarters, delivering an average surprise of 74.50%.
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.
Image: Bigstock
Merck Stock Up as Winrevair Meets Goal in Advanced PAH Study
Key Takeaways
Merck’s (MRK - Free Report) phase III study called ZENITH evaluating its pulmonary arterial hypertension (“PAH”) drug, Winrevair (sotatercept), for more advanced disease, met its primary endpoint.
The ZENITH study evaluated Winrevair, a novel activin signaling inhibitor, in patients with PAH, WHO Group 1 functional class (FC) III or IV at high risk of mortality. The study’s primary endpoint was time to first morbidity or mortality event, which could be either all-cause death, lung transplantation, or PAH hospitalizations.
Top-line data from the study showed that treatment with Winrevair added to background PAH therapy, leading to a statistically significant and clinically meaningful reduction in the risk of morbidity or mortality events compared to placebo. Based on the overwhelming efficacy seen in the study, an independent data monitoring committee (DMC) recommended the study be stopped early. The DMC also recommended that patients with this advanced form of PAH be offered the opportunity to get Winrevair through an open-label extension study.
Merck’s stock rose 2% on Monday as the positive data can potentially help expand the drug’s patient population.
So far this year, Merck’s stock has declined 7% against an increase of 5.7% for the industry.
Image Source: Zacks Investment Research
How Does MRK’s Winrevair Treat PAH?
Winrevair was approved to treat PAH WHO Group 1 in the United States in March based on data from the STELLAR study. It was approved for similar use in the EU in August 2024.
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.
Merck is also evaluating Winrevair in another phase III study called HYPERION in newly diagnosed intermediate- and high-risk PAH patients.
MRK Pins Hopes on Winrevair Ahead of Keytruda’s Loss of Patent
Winrevair is already seeing a strong launch, generating sales of $219 million this year. On the third-quarter conference call in October, the company said that the U.S. launch of the drug is gaining momentum, and the company is steadily adding new patients. More than 2,600 new commercial patients have started treatment since launch.
In EU, Merck has launched Winrevair in Germany. It expects to obtain reimbursement for Winrevair in most other European markets, which typically takes 12 months, by the second half of 2025.
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 added Winrevair following its $11 billion acquisition of Acceleron Pharma in 2021.
Other Players in the 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 $403.6 million, $326.5 million and $1.2 billion, 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 $3.19 billion from its PAH franchise in the first nine months of 2024, up 14% 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 Pfizer (PFE - Free Report) , carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
The Zacks Consensus Estimate for Pfizer’s earnings has risen from $2.67 to $2.91 per share for 2024 over the past 60 days, while that for 2025 has risen from $2.86 to $2.92. Pfizer’s shares have lost 9.1% year to date.
Pfizer beat on earnings in each of the trailing four quarters, delivering an average surprise of 74.50%.