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Moderna (MRNA) Up on Coronavirus Vaccine Candidate Progress
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Moderna, Inc. (MRNA - Free Report) announced that it has completed “case accrual” for the first interim analysis of its ongoing late-stage study — COVE — evaluating its coronavirus vaccine candidate, mRNA-1273. The company stated that it observed acceleration in rate of COVID-19 disease across study sites, which helped trigger the targeted trigger point of more than 53 infected participants for the first interim analysis.
Moderna will now submit data for analysis and recommendation to the independent Data Safety Monitoring Board (“DSMB”) and is currently preparing the same. The DSMB can recommend the vaccine for an emergency use authorization (“EUA”) to the FDA, if interim data supports. Per FDA’s guidelines, a vaccine will be considered effective if it is at least 50% effective.
Shares of Moderna were up 2.2% in after-hours trading following the announcement. The company’s shares have skyrocketed 321.5% so far this year against the industry’s decrease of 2.6%.
We note that in July, Moderna initiated the phase III study COVE on 100-microgram dose of mRNA-1273. The company completed enrollment of 30,000 participants in the study on Oct 22. Diversified patient population of the study includes high-risk groups as well as participants from communities of color. As of Oct 9, 2020, more than 22,194 volunteers were administered the second dose. The primary endpoint of the study is the prevention of symptomatic COVID-19 disease. Prevention of severe COVID-19 disease and prevention of infection by SARS-CoV-2 are included as secondary endpoints.
Please note that Pfizer (PFE - Free Report) and BioNTech (BNTX - Free Report) announced encouraging data from the first interim analysis of their late-stage coronavirus vaccine study earlier this week. The coronavirus vaccine candidate, BNT162b2, was found to be 90% effective at seven days after the second dose. The vaccine candidate was found to be safe. Pfizer anticipates to file for an EUA by the end of this month. Per a Financial Times article, the director of National Institute of Allergy and Infectious Diseases stated that he expects a similar degree of efficacy for Moderna’s vaccine. Candidates of Pfizer and Moderna are based on the novel mRNA platform.
Apart from mRNA-1273 and BNT162b2, the coronavirus vaccine candidate from AstraZeneca (AZN - Free Report) and Oxford University is another leading contender in this race. However, this candidate uses an adenovirus-based platform. The candidate is also in late-stage development. Statistically significant data from studies evaluating the leading candidate may lead to an EUA, which may help prevent the spread of the infection that is on the rise again.
In a separate release, Moderna announced positive interim data from a phase I study evaluating its mRNA personalized cancer vaccine, mRNA-4157, in combination with Merck’s Keytruda in certain head and neck squamous cell carcinoma, and colorectal cancer patients. Data showed that the combination regimen was well tolerated at all dose levels and produced responses as measured by tumor shrinkage.
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Moderna (MRNA) Up on Coronavirus Vaccine Candidate Progress
Moderna, Inc. (MRNA - Free Report) announced that it has completed “case accrual” for the first interim analysis of its ongoing late-stage study — COVE — evaluating its coronavirus vaccine candidate, mRNA-1273. The company stated that it observed acceleration in rate of COVID-19 disease across study sites, which helped trigger the targeted trigger point of more than 53 infected participants for the first interim analysis.
Moderna will now submit data for analysis and recommendation to the independent Data Safety Monitoring Board (“DSMB”) and is currently preparing the same. The DSMB can recommend the vaccine for an emergency use authorization (“EUA”) to the FDA, if interim data supports. Per FDA’s guidelines, a vaccine will be considered effective if it is at least 50% effective.
Shares of Moderna were up 2.2% in after-hours trading following the announcement. The company’s shares have skyrocketed 321.5% so far this year against the industry’s decrease of 2.6%.
We note that in July, Moderna initiated the phase III study COVE on 100-microgram dose of mRNA-1273. The company completed enrollment of 30,000 participants in the study on Oct 22. Diversified patient population of the study includes high-risk groups as well as participants from communities of color. As of Oct 9, 2020, more than 22,194 volunteers were administered the second dose. The primary endpoint of the study is the prevention of symptomatic COVID-19 disease. Prevention of severe COVID-19 disease and prevention of infection by SARS-CoV-2 are included as secondary endpoints.
Please note that Pfizer (PFE - Free Report) and BioNTech (BNTX - Free Report) announced encouraging data from the first interim analysis of their late-stage coronavirus vaccine study earlier this week. The coronavirus vaccine candidate, BNT162b2, was found to be 90% effective at seven days after the second dose. The vaccine candidate was found to be safe. Pfizer anticipates to file for an EUA by the end of this month. Per a Financial Times article, the director of National Institute of Allergy and Infectious Diseases stated that he expects a similar degree of efficacy for Moderna’s vaccine. Candidates of Pfizer and Moderna are based on the novel mRNA platform.
Apart from mRNA-1273 and BNT162b2, the coronavirus vaccine candidate from AstraZeneca (AZN - Free Report) and Oxford University is another leading contender in this race. However, this candidate uses an adenovirus-based platform. The candidate is also in late-stage development. Statistically significant data from studies evaluating the leading candidate may lead to an EUA, which may help prevent the spread of the infection that is on the rise again.
In a separate release, Moderna announced positive interim data from a phase I study evaluating its mRNA personalized cancer vaccine, mRNA-4157, in combination with Merck’s Keytruda in certain head and neck squamous cell carcinoma, and colorectal cancer patients. Data showed that the combination regimen was well tolerated at all dose levels and produced responses as measured by tumor shrinkage.
Moderna, Inc. Price
Moderna, Inc. price | Moderna, Inc. Quote
Zacks Rank
Moderna currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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