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Merck (MRK) Reports Detailed Data From PAH Study on Sotatercept
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Merck & Co. (MRK - Free Report) announced full results from the phase III STELLAR study, which evaluated its investigational pulmonary arterial hypertension (PAH) drug sotatercept.
The STELLAR study evaluated the safety and efficacy of sotatercept against placebo, as an add-on to the current standard of care for adults with PAH (WHO Group 1).
Back in October 2022, Merck said that the study achieved its primary and key secondary endpoints. The study had achieved its primary endpoint of sotatercept exhibiting significant improvement in exercise capacity, as measured by 6-minute walk distance (6MWD) following 24 weeks of treatment initiation.
However, in the present press release, the company said that sotatercept increased 6MWD by 40.8 meters from baseline at week 24.
In the past year, shares of Merck shot up 43% against the industry’s decline of 7.6%.
Image Source: Zacks Investment Research
Additionally, the study also achieved meaningful improvements in eight of nine key secondary outcome measures that included statistically significant improvements in WHO functional class and pulmonary vascular resistance.
Sotatercept reduced the risk of clinical deterioration or death by 84% in comparison with placebo with a median follow-up of 32.7 weeks. The safety profile of the drug is reported to be consistent with prior study data. Adverse events from the treatment with sotatercept were observed in 90.8% of the enrolled patients in comparison with 91.9% of patients treated with placebo.
Severe adverse reactions in treatment with sotatercept and placebo, separately, were observed in 12.9% and 18.1% of patients, respectively. Common complications included bleeding events, telangiectasia, increased hemoglobin levels, thrombocytopenia, increased blood pressure and dizziness.
PAH is a rare, progressive, blood vessel disorder that affects the arteries in the lungs and the right side of the heart resulting in elevated blood pressure in the pulmonary circulation. In the United States, an estimated 40,000 people currently live with PAH. It exerts significant strain on the heart consequentially causing limited physical activity, heart failure and reduced life expectancy.
PAH is hence life-threatening with a five-year mortality rate for patients with PAH of approximately 43%. Per management, sotatercept expresses the potential to target cellular signaling associated with vascular hyperproliferation and pathological remodeling for the treatment of PAH. Merck plans to hold discussions with the FDA soon regarding the pivotal data from the phase III STELLAR study to launch sotatercept as soon as possible.
Some better-ranked stocks in the large-cap pharma/biomedical-genetic industry are Novo Nordisk (NVO - Free Report) , Allogene Therapeutics, Inc. (ALLO - Free Report) and ADMA Biologics, Inc. (ADMA - Free Report) . While NVO currently sports a Zacks Rank #1 (Strong Buy), ALLO and ADMA both have a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 90 days, the estimate for Novo Nordisk’s 2023 earnings per share increased from $3.96 to $4.43. In the past year, the shares of Novo Nordisk have risen 37%.
NVO’s earnings witnessed an average earnings surprise of 3%, beating three of the four estimates in the trailing four reported quarters, missing the mark on one occasion.
In the past 90 days, the estimate for Allogene’s 2023 loss per share has narrowed from $2.86 to $2.56. In the past year, shares of Allogene have fallen 32.4%.
ALLO’s earnings witnessed an average earnings surprise of 8.33%, beating estimates in the trailing four quarters.
In the past 90 days, the consensus estimate for ADMA Biologics’ 2023 loss per share has narrowed from 20 cents to 19 cents. In the past year, the shares of ADMA Biologics have increased by 94.3%.
ADMA’s earnings beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 1.81%.
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Merck (MRK) Reports Detailed Data From PAH Study on Sotatercept
Merck & Co. (MRK - Free Report) announced full results from the phase III STELLAR study, which evaluated its investigational pulmonary arterial hypertension (PAH) drug sotatercept.
The STELLAR study evaluated the safety and efficacy of sotatercept against placebo, as an add-on to the current standard of care for adults with PAH (WHO Group 1).
Back in October 2022, Merck said that the study achieved its primary and key secondary endpoints. The study had achieved its primary endpoint of sotatercept exhibiting significant improvement in exercise capacity, as measured by 6-minute walk distance (6MWD) following 24 weeks of treatment initiation.
However, in the present press release, the company said that sotatercept increased 6MWD by 40.8 meters from baseline at week 24.
In the past year, shares of Merck shot up 43% against the industry’s decline of 7.6%.
Image Source: Zacks Investment Research
Additionally, the study also achieved meaningful improvements in eight of nine key secondary outcome measures that included statistically significant improvements in WHO functional class and pulmonary vascular resistance.
Sotatercept reduced the risk of clinical deterioration or death by 84% in comparison with placebo with a median follow-up of 32.7 weeks. The safety profile of the drug is reported to be consistent with prior study data. Adverse events from the treatment with sotatercept were observed in 90.8% of the enrolled patients in comparison with 91.9% of patients treated with placebo.
Severe adverse reactions in treatment with sotatercept and placebo, separately, were observed in 12.9% and 18.1% of patients, respectively. Common complications included bleeding events, telangiectasia, increased hemoglobin levels, thrombocytopenia, increased blood pressure and dizziness.
PAH is a rare, progressive, blood vessel disorder that affects the arteries in the lungs and the right side of the heart resulting in elevated blood pressure in the pulmonary circulation. In the United States, an estimated 40,000 people currently live with PAH. It exerts significant strain on the heart consequentially causing limited physical activity, heart failure and reduced life expectancy.
PAH is hence life-threatening with a five-year mortality rate for patients with PAH of approximately 43%. Per management, sotatercept expresses the potential to target cellular signaling associated with vascular hyperproliferation and pathological remodeling for the treatment of PAH. Merck plans to hold discussions with the FDA soon regarding the pivotal data from the phase III STELLAR study to launch sotatercept as soon as possible.
Merck & Co., Inc. Price and Consensus
Merck & Co., Inc. price-consensus-chart | Merck & Co., Inc. Quote
Zacks Rank & Stocks to Consider
Merck currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the large-cap pharma/biomedical-genetic industry are Novo Nordisk (NVO - Free Report) , Allogene Therapeutics, Inc. (ALLO - Free Report) and ADMA Biologics, Inc. (ADMA - Free Report) . While NVO currently sports a Zacks Rank #1 (Strong Buy), ALLO and ADMA both have a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 90 days, the estimate for Novo Nordisk’s 2023 earnings per share increased from $3.96 to $4.43. In the past year, the shares of Novo Nordisk have risen 37%.
NVO’s earnings witnessed an average earnings surprise of 3%, beating three of the four estimates in the trailing four reported quarters, missing the mark on one occasion.
In the past 90 days, the estimate for Allogene’s 2023 loss per share has narrowed from $2.86 to $2.56. In the past year, shares of Allogene have fallen 32.4%.
ALLO’s earnings witnessed an average earnings surprise of 8.33%, beating estimates in the trailing four quarters.
In the past 90 days, the consensus estimate for ADMA Biologics’ 2023 loss per share has narrowed from 20 cents to 19 cents. In the past year, the shares of ADMA Biologics have increased by 94.3%.
ADMA’s earnings beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 1.81%.