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Merck (MRK) Gets FDA Approval for New PAH Drug Winrevair
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Merck (MRK - Free Report) announced that the FDA has granted approval to its novel activin signaling inhibitor, sotatercept, for treating adult patients with pulmonary arterial hypertension (PAH, WHO Group 1). The drug will be marketed by the name of Winrevair.
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 41 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’s safety label mentions that it may increase hemoglobin and may lead to erythrocytosis, which means a high concentration of red blood cells.
Merck’s stock rose almost 5% in after-hours trading in response to Winrevair’s approval as the drug holds the key to Merck’s long-term growth plans. Analysts believe Winrevair has blockbuster potential in PAH.
Merck’s stock has risen 21.6% in the past year compared with an increase of 27.3% for the industry.
Image Source: Zacks Investment Research
PAH is a rare, progressive blood vessel disorder that affects the blood vessel walls n 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.
Winrevair is the first novel activin signaling inhibitor approved by the FDA to treat PAH. The FDA had earlier granted the drug breakthrough therapy and orphan drug designations for PAH treatment. 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.
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 $494.8 million, $359.4 million and $1.23 billion, respectively, in 2023.
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 $3.8 billion from its PAH franchise in 2023, rising 11.6% year over year.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have improved from 22 cents to 30 cents. Estimates for 2025 have increased from 32 cents to 50 cents. In the past year, shares of ADMA Biologics have risen 95.8%.
Earnings of ADMA Biologics beat estimates in three of the last four quarters while meeting the same once. ADMA delivered a four-quarter average earnings surprise of 85.0%.
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Merck (MRK) Gets FDA Approval for New PAH Drug Winrevair
Merck (MRK - Free Report) announced that the FDA has granted approval to its novel activin signaling inhibitor, sotatercept, for treating adult patients with pulmonary arterial hypertension (PAH, WHO Group 1). The drug will be marketed by the name of Winrevair.
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 41 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’s safety label mentions that it may increase hemoglobin and may lead to erythrocytosis, which means a high concentration of red blood cells.
Merck’s stock rose almost 5% in after-hours trading in response to Winrevair’s approval as the drug holds the key to Merck’s long-term growth plans. Analysts believe Winrevair has blockbuster potential in PAH.
Merck’s stock has risen 21.6% in the past year compared with an increase of 27.3% for the industry.
Image Source: Zacks Investment Research
PAH is a rare, progressive blood vessel disorder that affects the blood vessel walls n 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.
Winrevair is the first novel activin signaling inhibitor approved by the FDA to treat PAH. The FDA had earlier granted the drug breakthrough therapy and orphan drug designations for PAH treatment. 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.
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 $494.8 million, $359.4 million and $1.23 billion, respectively, in 2023.
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 $3.8 billion from its PAH franchise in 2023, rising 11.6% 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 in the healthcare sector is ADMA Biologics (ADMA - Free Report) , sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share have improved from 22 cents to 30 cents. Estimates for 2025 have increased from 32 cents to 50 cents. In the past year, shares of ADMA Biologics have risen 95.8%.
Earnings of ADMA Biologics beat estimates in three of the last four quarters while meeting the same once. ADMA delivered a four-quarter average earnings surprise of 85.0%.