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Moderna (MRNA), Merck's Cancer Jab Delays Melanoma Recurrence
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Moderna (MRNA - Free Report) and partner Merck (MRK - Free Report) announced detailed results from the phase IIb KEYNOTE-942 study, which evaluated their personalized cancer vaccine (“PCV”) candidate, mRNA-4157/V940, in melanoma indication. These results were announced at the 2023 American Association for Cancer Research Annual Meeting.
Last December, Moderna announced that the study achieved its primary endpoint of recurrence-free survival (“RFS”). Data from the study showed that mRNA-4157, when combined with Merck’s blockbuster immuno-oncology drug Keytruda, exhibited a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death by 44%. The study’s results also suggested that a personalized neoantigen approach may benefit melanoma patients.
In the latest data presentation, Moderna and Merck revealed that after a follow-up period of around two years, 22.4% of patients treated with mRNA-4157/Keytruda combination reported disease recurrence/death compared to 40% in the control arm. Data from a subgroup analysis of the study also showed that the improvement in RFS was regardless of tumor mutational burden status.
Based on a detailed analysis of the above data, management now believes that the mRNA-4157/Keytruda combination has the potential to extend the lives of patients with high-risk melanoma.
The KEYNOTE-942 study evaluated the combination of mRNA-4157/V940 and Keytruda, compared to Keytruda alone, as an adjuvant treatment for stage III/IV melanoma patients with a high risk of recurrence following complete resection.
Moderna and Merck are currently discussing the above results with regulatory authorities and also intend to start a phase III study in melanoma patients later this year. The companies also plan to expand the PCV vaccine to other cancer indications, including non-small cell lung cancer.
In the year so far, Moderna has lost 12.5% compared with the industry’s 4.2% fall.
Image Source: Zacks Investment Research
Based on data from the KEYNOTE-942 study, the mRNA-4157/Keytruda combination has been granted Priority Medicines (“PRIME”) scheme and breakthrough therapy designations in the European Union and the United States, respectively, in melanoma indication. The grant of these two designations provides Moderna and Merck proactive support from the regulatory agencies in the development of their combination therapy.
Merck and Moderna entered a strategic partnership in 2016 to develop and commercialize mRNA-based personalized vaccines for treating various types of cancer. Last October, Merck exercised its option to develop the PCV vaccine with Moderna. Per the terms of collaboration, the companies will share costs and profits equally.
Unlike other vaccines that are uniformly designed to treat all patients, the PCV vaccine aims to bring individualized treatment to cancer patients. mRNA-4157 is tailored for each patient, based on the unique mutational signature of a patient's tumor.
As opposed to traditional vaccines, mRNA-based vaccines teach the body how to make a specific protein that can help your immune system prevent or treat certain diseases.The COVID-19 pandemic has further demonstrated the significant potential of mRNA-based therapeutics. By way of COVID vaccines, Moderna and Pfizer have generated immune responses against the virus at record-high levels compared to traditional protein-based and adeno-based vaccines.
In the past 60 days, estimates for Ligand Pharmaceuticals’ 2023 earnings per share have increased from $3.30 to $4.15. During the same period, the earnings estimates per share for 2024 have risen from $3.10 to $4.57. Shares of Ligand Pharmaceuticals have gained 11.3% in the year-to-date period.
Earnings of LGND beat estimates in one of the last four quarters while missing the mark on the other three occasions. On average, the company’s earnings witnessed a negative surprise of 10.07%. In the last reported quarter, Ligand Pharmaceuticals’ earnings beat estimates by 10.57%.
In the past 60 days, estimates for Lisata Therapeutics’ 2023 loss per share have improved from $3.81 to $3.58. During the same period, the loss estimates per share for 2024 have narrowed from $4.01 to $3.12. Shares of Lisata Therapeutics have gained 23.3% in the year-to-date period.
Earnings of LSTA beat estimates in two of the last four quarters while missing the mark on the other two occasions. On average, the company’s earnings witnessed a negative surprise of 5.63%. In the last reported quarter, Lisata Therapeutics’ earnings beat estimates by 20.83%.
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Moderna (MRNA), Merck's Cancer Jab Delays Melanoma Recurrence
Moderna (MRNA - Free Report) and partner Merck (MRK - Free Report) announced detailed results from the phase IIb KEYNOTE-942 study, which evaluated their personalized cancer vaccine (“PCV”) candidate, mRNA-4157/V940, in melanoma indication. These results were announced at the 2023 American Association for Cancer Research Annual Meeting.
Last December, Moderna announced that the study achieved its primary endpoint of recurrence-free survival (“RFS”). Data from the study showed that mRNA-4157, when combined with Merck’s blockbuster immuno-oncology drug Keytruda, exhibited a statistically significant and clinically meaningful reduction in the risk of disease recurrence or death by 44%. The study’s results also suggested that a personalized neoantigen approach may benefit melanoma patients.
In the latest data presentation, Moderna and Merck revealed that after a follow-up period of around two years, 22.4% of patients treated with mRNA-4157/Keytruda combination reported disease recurrence/death compared to 40% in the control arm. Data from a subgroup analysis of the study also showed that the improvement in RFS was regardless of tumor mutational burden status.
Based on a detailed analysis of the above data, management now believes that the mRNA-4157/Keytruda combination has the potential to extend the lives of patients with high-risk melanoma.
The KEYNOTE-942 study evaluated the combination of mRNA-4157/V940 and Keytruda, compared to Keytruda alone, as an adjuvant treatment for stage III/IV melanoma patients with a high risk of recurrence following complete resection.
Moderna and Merck are currently discussing the above results with regulatory authorities and also intend to start a phase III study in melanoma patients later this year. The companies also plan to expand the PCV vaccine to other cancer indications, including non-small cell lung cancer.
In the year so far, Moderna has lost 12.5% compared with the industry’s 4.2% fall.
Image Source: Zacks Investment Research
Based on data from the KEYNOTE-942 study, the mRNA-4157/Keytruda combination has been granted Priority Medicines (“PRIME”) scheme and breakthrough therapy designations in the European Union and the United States, respectively, in melanoma indication. The grant of these two designations provides Moderna and Merck proactive support from the regulatory agencies in the development of their combination therapy.
Merck and Moderna entered a strategic partnership in 2016 to develop and commercialize mRNA-based personalized vaccines for treating various types of cancer. Last October, Merck exercised its option to develop the PCV vaccine with Moderna. Per the terms of collaboration, the companies will share costs and profits equally.
Unlike other vaccines that are uniformly designed to treat all patients, the PCV vaccine aims to bring individualized treatment to cancer patients. mRNA-4157 is tailored for each patient, based on the unique mutational signature of a patient's tumor.
As opposed to traditional vaccines, mRNA-based vaccines teach the body how to make a specific protein that can help your immune system prevent or treat certain diseases.The COVID-19 pandemic has further demonstrated the significant potential of mRNA-based therapeutics. By way of COVID vaccines, Moderna and Pfizer have generated immune responses against the virus at record-high levels compared to traditional protein-based and adeno-based vaccines.
Moderna, Inc. Price
Moderna, Inc. price | Moderna, Inc. Quote
Zacks Rank & Stocks to Consider
Moderna currently carries a Zacks Rank #4 (Sell). A couple of better-ranked stocks in the overall healthcare sector include Ligand Pharmaceuticals (LGND - Free Report) and Lisata Therapeutics (LSTA - 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 Ligand Pharmaceuticals’ 2023 earnings per share have increased from $3.30 to $4.15. During the same period, the earnings estimates per share for 2024 have risen from $3.10 to $4.57. Shares of Ligand Pharmaceuticals have gained 11.3% in the year-to-date period.
Earnings of LGND beat estimates in one of the last four quarters while missing the mark on the other three occasions. On average, the company’s earnings witnessed a negative surprise of 10.07%. In the last reported quarter, Ligand Pharmaceuticals’ earnings beat estimates by 10.57%.
In the past 60 days, estimates for Lisata Therapeutics’ 2023 loss per share have improved from $3.81 to $3.58. During the same period, the loss estimates per share for 2024 have narrowed from $4.01 to $3.12. Shares of Lisata Therapeutics have gained 23.3% in the year-to-date period.
Earnings of LSTA beat estimates in two of the last four quarters while missing the mark on the other two occasions. On average, the company’s earnings witnessed a negative surprise of 5.63%. In the last reported quarter, Lisata Therapeutics’ earnings beat estimates by 20.83%.