We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
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.
MRK's Winrevair Phase III Study in Newly Diagnosed PAH Meets Goal
Read MoreHide Full Article
Key Takeaways
MRK's HYPERION study met its primary goal, reducing clinical worsening in newly diagnosed PAH patients.
The HYPERION study was stopped early due to strong efficacy seen in the ZENITH study and other data.
Winrevair sales reached $280M in Q1 2025, growing 40% sequentially with strong U.S. prescription trends.
Merck (MRK - Free Report) announced that the phase III HYPERION study evaluating its pulmonary arterial hypertension (“PAH”) drug, Winrevair (sotatercept), in newly diagnosed intermediate or high-risk PAH patients, met its primary endpoint.
The HYPERION study evaluated Winrevair versus placebo in recently diagnosed adult patients with PAH, WHO Group 1 functional class (FC) II or III at intermediate or high risk of disease progression. The study’s primary endpoint was time to clinical worsening (TTCW) as measured by a composite endpoint of all-cause death, including the need for non-planned PAH-related hospitalization, atrial septostomy, lung transplantation or worsening PAH symptoms.
Data from the HYPERION study showed that treatment with Winrevair added to background PAH therapy within 12 months after initial diagnosis led to a statistically significant and clinically meaningful reduction in the risk of clinical worsening events versus placebo.
In January, Merck announced that the HYPERION study was stopped early and moved to final analysis, based on overwhelming efficacy seen in the phase III ZENITH study and review of available data from the Winrevair clinical program, including the STELLAR study.
HYPERION is the third phase III study on Winrevair to demonstrate significant efficacy in adults with PAH, the first being the STELLAR study, followed by the ZENITH study.
Year to date, shares of Merck have lost 19.4% compared with the industry’s decrease of 2.6%.
Image Source: Zacks Investment Research
MRK Pins Hope on Winrevair Amid Looming Keytruda LOE
Winrevair was approved by the FDA to treat PAH, WHO Group 1, in March 2024 based on data from the STELLAR study. The drug 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 lungs.
Winrevair generated sales worth $280 million in the first quarter of 2025, increasing 40% on a sequential basis. Per management, Winrevair continues to perform in line with the company’s high expectations in the United States, as evident from a steady increase in new prescription trends. In ex-U.S. markets, MRK is progressing with launches and reimbursement.
Merck is pinning hopes on Winrevair to boost its top line once its blockbuster drug, Keytruda, a PD-L1 inhibitor, loses patent exclusivity in 2028. The company believes that Winrevair has the potential to generate significant revenues over the long term.
Other Players in the PAH Market
Significant players in the PAH market are United Therapeutics (UTHR - Free Report) and Johnson & Johnson (JNJ - Free Report) .
UTHR 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. UTHR’s Remodulin, Orenitram and Tyvaso recorded sales of $138.2 million, $120.7 million and $466.3 million, respectively, in the first quarter of 2025.
J&J’s key PAH drugs include Opsumit and Uptravi. JNJ recorded revenues of $1.02 billion from its PAH franchise in the first quarter of 2025.
In the past 60 days, estimates for Exelixis’ earnings per share have increased from $2.31 to $2.61 for 2025. During the same time, earnings per share estimates for 2026 have increased from $2.83 to $3.03. Year to date, shares of EXEL have rallied 30.2%.
EXEL’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 48.60%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
MRK's Winrevair Phase III Study in Newly Diagnosed PAH Meets Goal
Key Takeaways
Merck (MRK - Free Report) announced that the phase III HYPERION study evaluating its pulmonary arterial hypertension (“PAH”) drug, Winrevair (sotatercept), in newly diagnosed intermediate or high-risk PAH patients, met its primary endpoint.
The HYPERION study evaluated Winrevair versus placebo in recently diagnosed adult patients with PAH, WHO Group 1 functional class (FC) II or III at intermediate or high risk of disease progression. The study’s primary endpoint was time to clinical worsening (TTCW) as measured by a composite endpoint of all-cause death, including the need for non-planned PAH-related hospitalization, atrial septostomy, lung transplantation or worsening PAH symptoms.
Data from the HYPERION study showed that treatment with Winrevair added to background PAH therapy within 12 months after initial diagnosis led to a statistically significant and clinically meaningful reduction in the risk of clinical worsening events versus placebo.
In January, Merck announced that the HYPERION study was stopped early and moved to final analysis, based on overwhelming efficacy seen in the phase III ZENITH study and review of available data from the Winrevair clinical program, including the STELLAR study.
HYPERION is the third phase III study on Winrevair to demonstrate significant efficacy in adults with PAH, the first being the STELLAR study, followed by the ZENITH study.
Year to date, shares of Merck have lost 19.4% compared with the industry’s decrease of 2.6%.
Image Source: Zacks Investment Research
MRK Pins Hope on Winrevair Amid Looming Keytruda LOE
Winrevair was approved by the FDA to treat PAH, WHO Group 1, in March 2024 based on data from the STELLAR study. The drug 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 lungs.
Winrevair generated sales worth $280 million in the first quarter of 2025, increasing 40% on a sequential basis. Per management, Winrevair continues to perform in line with the company’s high expectations in the United States, as evident from a steady increase in new prescription trends. In ex-U.S. markets, MRK is progressing with launches and reimbursement.
Merck is pinning hopes on Winrevair to boost its top line once its blockbuster drug, Keytruda, a PD-L1 inhibitor, loses patent exclusivity in 2028. The company believes that Winrevair has the potential to generate significant revenues over the long term.
Other Players in the PAH Market
Significant players in the PAH market are United Therapeutics (UTHR - Free Report) and Johnson & Johnson (JNJ - Free Report) .
UTHR 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. UTHR’s Remodulin, Orenitram and Tyvaso recorded sales of $138.2 million, $120.7 million and $466.3 million, respectively, in the first quarter of 2025.
J&J’s key PAH drugs include Opsumit and Uptravi. JNJ recorded revenues of $1.02 billion from its PAH franchise in the first quarter of 2025.
MRK's Zacks Rank & Stock to Consider
Merck currently carries a Zacks Rank #3 (Hold).
A better-ranked stock in the biotech sector is Exelixis (EXEL - Free Report) , which has a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Exelixis’ earnings per share have increased from $2.31 to $2.61 for 2025. During the same time, earnings per share estimates for 2026 have increased from $2.83 to $3.03. Year to date, shares of EXEL have rallied 30.2%.
EXEL’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 48.60%.