We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Moderna (MRNA) COVID-19 Vaccine MAA Under Rolling Review in EU
Read MoreHide Full Article
Moderna, Inc. (MRNA - Free Report) announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) has started rolling review of its marketing authorization application for its coronavirus vaccine candidate, mRNA-1273. The MAA was accepted for rolling review based on preclinical, clinical, and chemistry, manufacturing and controls data available so far.
We note that Moderna had filed a letter of intent to the EMA seeking consent to file an MAA based on positive data from a preclinical viral challenge study and interim data from a phase I study. Last month, the EMA confirmed Moderna’s eligibility to file an MAA for mRNA-1273.
Shares of Moderna have surged 400.8% so far this year compared with the industry’s increase of 0.5%.
Earlier this week, Moderna announced that its vaccine candidate achieved an efficacy rate of 94.5% in the first interim analysis of ongoing phase III study — COVE — evaluating it in 30,000 participants with diverse backgrounds in the United States, including high-risk groups. Interim analysis of the COVE study included 95 participants who were infected with COVID-19. Among them 90 cases were observed in the placebo group versus five cases in the mRNA-1273 vaccinated group. Notably, the first analyses identified 11 severe cases of COVID-19 in the placebo group but none in the vaccinated group. Based on these interim safety and efficacy data, the company plans to submit an emergency use authorization (“EUA”) to the FDA in the coming weeks.
Encouraging interim data from the COVE study may also support a recommendation for approval from the CHMP. Moderna is already working with strategic manufacturing partners, namely Lonza of Switzerland and ROVI of Spain for fill-finish and manufacturing of the vaccine candidate. The company is ramping up the global manufacturing activity and is looking to deliver around 500 million doses of mRNA-1273 in 2020 and up to 1 billion doses annually, beginning next year.
Moreover, data from the phase I study has also shown that vaccination with 100 micro-grams of mRNA-1273 generated neutralizing antibody titers in all patients in the 18-55 age group of the study. Moreover, mRNA-1273 induced consistently high levels of pseudovirus neutralization antibody titers in all participants in the groups aged 56-70, and 71 or above.
In a separate release, Moderna announced that it has signed a supply agreement with government of the United Kingdom for mRNA-1273. The company will start supplying mRNA-1273 in the country from March 2021, if approved.
We note that last week, both Pfizer (PFE - Free Report) and BioNTech (BNTX - Free Report) also announced that their mRNA-based vaccine candidate achieved more than 90% efficacy rate in seven days after the second dose. These companies had started rolling submission for marketing authorization for their candidate in Europe in October. We note that Pfizer/BioNtech’s candidate may face logistical hurdles due to its storage requirement of ultra-low temperature.
Apart from Moderna and Pfizer, AstraZeneca (AZN - Free Report) in partnership with Oxford University is evaluating their adenovirus-based coronavirus vaccine candidate, AZD1222 in late-stage studies. J&J is also developing a single dose coronavirus vaccine candidate, JNJ-78436735, in a phase III study.
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
You know this company from its past glory days, but few would expect that it’s poised for a monster turnaround. Fresh from a successful repositioning and flush with A-list celeb endorsements, it could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in a little more than 9 months and Nvidia which boomed +175.9% in one year.
Image: Bigstock
Moderna (MRNA) COVID-19 Vaccine MAA Under Rolling Review in EU
Moderna, Inc. (MRNA - Free Report) announced that the Committee for Medicinal Products for Human Use (“CHMP”) of the European Medicines Agency (“EMA”) has started rolling review of its marketing authorization application for its coronavirus vaccine candidate, mRNA-1273. The MAA was accepted for rolling review based on preclinical, clinical, and chemistry, manufacturing and controls data available so far.
We note that Moderna had filed a letter of intent to the EMA seeking consent to file an MAA based on positive data from a preclinical viral challenge study and interim data from a phase I study. Last month, the EMA confirmed Moderna’s eligibility to file an MAA for mRNA-1273.
Shares of Moderna have surged 400.8% so far this year compared with the industry’s increase of 0.5%.
Earlier this week, Moderna announced that its vaccine candidate achieved an efficacy rate of 94.5% in the first interim analysis of ongoing phase III study — COVE — evaluating it in 30,000 participants with diverse backgrounds in the United States, including high-risk groups. Interim analysis of the COVE study included 95 participants who were infected with COVID-19. Among them 90 cases were observed in the placebo group versus five cases in the mRNA-1273 vaccinated group. Notably, the first analyses identified 11 severe cases of COVID-19 in the placebo group but none in the vaccinated group. Based on these interim safety and efficacy data, the company plans to submit an emergency use authorization (“EUA”) to the FDA in the coming weeks.
Encouraging interim data from the COVE study may also support a recommendation for approval from the CHMP. Moderna is already working with strategic manufacturing partners, namely Lonza of Switzerland and ROVI of Spain for fill-finish and manufacturing of the vaccine candidate. The company is ramping up the global manufacturing activity and is looking to deliver around 500 million doses of mRNA-1273 in 2020 and up to 1 billion doses annually, beginning next year.
Moreover, data from the phase I study has also shown that vaccination with 100 micro-grams of mRNA-1273 generated neutralizing antibody titers in all patients in the 18-55 age group of the study. Moreover, mRNA-1273 induced consistently high levels of pseudovirus neutralization antibody titers in all participants in the groups aged 56-70, and 71 or above.
In a separate release, Moderna announced that it has signed a supply agreement with government of the United Kingdom for mRNA-1273. The company will start supplying mRNA-1273 in the country from March 2021, if approved.
We note that last week, both Pfizer (PFE - Free Report) and BioNTech (BNTX - Free Report) also announced that their mRNA-based vaccine candidate achieved more than 90% efficacy rate in seven days after the second dose. These companies had started rolling submission for marketing authorization for their candidate in Europe in October. We note that Pfizer/BioNtech’s candidate may face logistical hurdles due to its storage requirement of ultra-low temperature.
Apart from Moderna and Pfizer, AstraZeneca (AZN - Free Report) in partnership with Oxford University is evaluating their adenovirus-based coronavirus vaccine candidate, AZD1222 in late-stage studies. J&J is also developing a single dose coronavirus vaccine candidate, JNJ-78436735, in a phase III study.
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.
Zacks Names “Single Best Pick to Double”
From thousands of stocks, 5 Zacks experts each have chosen their favorite to skyrocket +100% or more in months to come. From those 5, Director of Research Sheraz Mian hand-picks one to have the most explosive upside of all.
You know this company from its past glory days, but few would expect that it’s poised for a monster turnaround. Fresh from a successful repositioning and flush with A-list celeb endorsements, it could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in a little more than 9 months and Nvidia which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>