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Merck (MRK) Keytruda Advanced Cervical Cancer Study Meets Goal
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Merck (MRK - Free Report) announced positive data from the ongoing phase III KEYNOTE-A18 study evaluating Keytruda, its blockbuster anti-PD-1 therapy, as a combination therapy for treating newly-diagnosed patients with high-risk locally advanced cervical cancer.
Based on an interim analysis of data, the study achieved one of its primary endpoints of progression-free survival (“PFS”). Though a favorable trend was observed in the study’s other primary endpoint of overall survival (“OS”), the data is yet to mature to determine whether the same has been achieved or not. Until this is determined, management will continue to follow-up on patients in the KEYNOTE-A18 study. There were no new safety signals reported in the study and the safety profile of Keytruda was in line with observations in its previously-conducted studies.
Merck plans to present the results at a future medical meeting and also submit the same to regulatory authorities for label expansion in cervical cancer indication.
Keytruda is currently approved in the United States for two indications in cervical cancer — as a single agent as well as a combination therapy with Keytruda — to treat certain cervical cancer patients whose tumors express PD-L1.
Merck’s shares have lost 4.5% year to date compared with the industry’s 0.3% decline.
Image Source: Zacks Investment Research
Per management, more than half of the patients with high-risk locally advanced gastric cancer experience disease recurrence within two years. Not only do these patients often have a poor prognosis, but also have limited options beyond standard-of-care treatments. The results from the KEYNOTE-A18 study show that Keytruda plus concurrent chemoradiotherapy demonstrated statistically significant and clinically meaningful improvement in PFS compared with concurrent chemoradiotherapy alone.
Merck’s Keytruda is already approved for the treatment of many cancers globally. Keytruda sales are gaining from continued strong momentum in metastatic indications, including in some types of NSCLC, renal cell carcinoma, head and neck squamous cell carcinoma, TNBC and MSI-H cancers and a rapid uptake across recent earlier-stage launches.
Keytruda is continuously growing and expanding into new indications and markets globally. Numerous recent approvals and the expected launch of many additional indications, including in earlier lines of therapy can further boost sales. In first-quarter 2023, Merck recorded $5.8 billion from Keytruda product sales.
In the past 60 days, estimates for Erasca’s 2023 loss per share have narrowed from $1.34 to $1.29. In the same period, the loss per share estimate for 2024 has improved from $1.71 to $1.54. Shares of ERAS have declined 37.1% in the year-to-date period.
Earnings of Erasca beat estimates in each of the last four quarters, witnessing an earnings surprise of 12.89%, on average. In the last reported quarter, ERAS earnings beat estimates by 26.67%.
In the past 60 days, estimates for Omega Therapeutics’ 2023 loss per share have narrowed from $2.18 to $2.05. During the same period, the loss estimates per share for 2024 have improved from $2.22 to $2.01. In the year so far, shares of OMGA have lost 8.9%.
Earnings of Omega Therapeutics beat estimates in two of the last four quarters, missed the mark on one occasion while meeting the mark on another. On average, the company witnessed an earnings surprise of 8.24%. In the last reported quarter, OMGA’searnings beat estimates by 21.88%.
In the past 60 days, estimates for Werewolf Therapeutics’ 2023 loss per share have narrowed from $1.42 to $1.29. During the same period, the loss estimates per share for 2024 have improved from $1.81 to $1.37. Year to date, shares of HOWL have surged 63.4%.
Earnings of Werewolf Therapeutics beat estimates in three of the last four quarters while missing the mark on one occasion, witnessing an earnings surprise of 5.29%, on average. In the last reported quarter, HOWL’s earnings beat estimates by 30.61%.
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Merck (MRK) Keytruda Advanced Cervical Cancer Study Meets Goal
Merck (MRK - Free Report) announced positive data from the ongoing phase III KEYNOTE-A18 study evaluating Keytruda, its blockbuster anti-PD-1 therapy, as a combination therapy for treating newly-diagnosed patients with high-risk locally advanced cervical cancer.
Based on an interim analysis of data, the study achieved one of its primary endpoints of progression-free survival (“PFS”). Though a favorable trend was observed in the study’s other primary endpoint of overall survival (“OS”), the data is yet to mature to determine whether the same has been achieved or not. Until this is determined, management will continue to follow-up on patients in the KEYNOTE-A18 study. There were no new safety signals reported in the study and the safety profile of Keytruda was in line with observations in its previously-conducted studies.
Merck plans to present the results at a future medical meeting and also submit the same to regulatory authorities for label expansion in cervical cancer indication.
Keytruda is currently approved in the United States for two indications in cervical cancer — as a single agent as well as a combination therapy with Keytruda — to treat certain cervical cancer patients whose tumors express PD-L1.
Merck’s shares have lost 4.5% year to date compared with the industry’s 0.3% decline.
Image Source: Zacks Investment Research
Per management, more than half of the patients with high-risk locally advanced gastric cancer experience disease recurrence within two years. Not only do these patients often have a poor prognosis, but also have limited options beyond standard-of-care treatments. The results from the KEYNOTE-A18 study show that Keytruda plus concurrent chemoradiotherapy demonstrated statistically significant and clinically meaningful improvement in PFS compared with concurrent chemoradiotherapy alone.
Merck’s Keytruda is already approved for the treatment of many cancers globally. Keytruda sales are gaining from continued strong momentum in metastatic indications, including in some types of NSCLC, renal cell carcinoma, head and neck squamous cell carcinoma, TNBC and MSI-H cancers and a rapid uptake across recent earlier-stage launches.
Keytruda is continuously growing and expanding into new indications and markets globally. Numerous recent approvals and the expected launch of many additional indications, including in earlier lines of therapy can further boost sales. In first-quarter 2023, Merck recorded $5.8 billion from Keytruda product sales.
Merck & Co., Inc. Price
Merck & Co., Inc. price | Merck & Co., Inc. Quote
Zacks Rank & Stocks to Consider
Merck currently carries a Zacks Rank #4 (Sell). Some other top-ranked stocks in the overall healthcare sector include Erasca (ERAS - Free Report) , Omega Therapeutics (OMGA - Free Report) and Werewolf Therapeutics (HOWL - Free Report) , each 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 Erasca’s 2023 loss per share have narrowed from $1.34 to $1.29. In the same period, the loss per share estimate for 2024 has improved from $1.71 to $1.54. Shares of ERAS have declined 37.1% in the year-to-date period.
Earnings of Erasca beat estimates in each of the last four quarters, witnessing an earnings surprise of 12.89%, on average. In the last reported quarter, ERAS earnings beat estimates by 26.67%.
In the past 60 days, estimates for Omega Therapeutics’ 2023 loss per share have narrowed from $2.18 to $2.05. During the same period, the loss estimates per share for 2024 have improved from $2.22 to $2.01. In the year so far, shares of OMGA have lost 8.9%.
Earnings of Omega Therapeutics beat estimates in two of the last four quarters, missed the mark on one occasion while meeting the mark on another. On average, the company witnessed an earnings surprise of 8.24%. In the last reported quarter, OMGA’searnings beat estimates by 21.88%.
In the past 60 days, estimates for Werewolf Therapeutics’ 2023 loss per share have narrowed from $1.42 to $1.29. During the same period, the loss estimates per share for 2024 have improved from $1.81 to $1.37. Year to date, shares of HOWL have surged 63.4%.
Earnings of Werewolf Therapeutics beat estimates in three of the last four quarters while missing the mark on one occasion, witnessing an earnings surprise of 5.29%, on average. In the last reported quarter, HOWL’s earnings beat estimates by 30.61%.