Moderna, Inc. (MRNA - Free Report) announced that it has initiated rolling submission for a biologics license application (BLA) with the FDA seeking approval/licensure of its COVID-19 vaccine, mRNA-1273, in adults. The company will continue to submit data from ongoing clinical and other studies to support the BLA and plans to request the FDA for a priority review of the regulatory application.
Please note that mRNA-1273 is currently available under emergency use authorization (“EUA”) in the United States. The vaccine has also received similar emergency/conditional/temporary authorization in multiple countries. An EUA means authorization for a particular product remains in effect for as long as public health emergency lasts. A potential approval to the BLA for mRNA-1273 will allow Moderna continue to commercialize the COVID-19 vaccine even after the emergency situation recedes with lowering infection cases. Please note that none of the available COVID-19 vaccines have received an approval so far.
Last month, Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) initiated rolling submission for a BLA seeking approval for their mRNA-based COVID-19 vaccine, BNT162b2.
Meanwhile, Moderna is also focusing on increasing its manufacturing capacity for its COVID-19 vaccine as well as for investigational booster doses.
The company announced a new agreement with its existing Switzerland-based partner, Lonza, for supply of drug substance for an additional 300 million doses of its updated booster variant vaccine candidate annually, following a potential authorization. Moderna has also signed a similar agreement with Spain-based ROVI for another 300 million doses of booster vaccine.
The company has also signed several fill/finish agreements with multiple companies to support manufacturing services and supply packaging for COVID-19 vaccine. It signed an agreement for similar services with Thermo Fisher Scientific (TMO - Free Report) to support the production of hundreds of millions of doses that will start in the third quarter of 2021.
Moderna’s stock has gained 76.7% in the year so far against the industry's decline of 4.1%.
We remind investors that mRNA-1273 achieved an efficacy rate of 94.1% during the primary efficacy analysis of the phase III COVE study evaluating it in adult patients. Meanwhile, the vaccine achieved 100% efficacy in adolescent patients in a phase II/III study. Another phase II/III study is evaluating mRNA-1273 in in children aged six months to less than 12 years.
The company is also developing booster vaccine candidates targeting different variants of coronavirus and a refrigeration-stable COVID-19 vaccine candidate, mRNA-1283, to facilitate easier distribution and administration.
Zacks Rank
Moderna currently carries 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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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.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
Moderna, Inc. (MRNA - Free Report) announced that it has initiated rolling submission for a biologics license application (BLA) with the FDA seeking approval/licensure of its COVID-19 vaccine, mRNA-1273, in adults. The company will continue to submit data from ongoing clinical and other studies to support the BLA and plans to request the FDA for a priority review of the regulatory application.
Please note that mRNA-1273 is currently available under emergency use authorization (“EUA”) in the United States. The vaccine has also received similar emergency/conditional/temporary authorization in multiple countries. An EUA means authorization for a particular product remains in effect for as long as public health emergency lasts. A potential approval to the BLA for mRNA-1273 will allow Moderna continue to commercialize the COVID-19 vaccine even after the emergency situation recedes with lowering infection cases. Please note that none of the available COVID-19 vaccines have received an approval so far.
Last month, Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) initiated rolling submission for a BLA seeking approval for their mRNA-based COVID-19 vaccine, BNT162b2.
Meanwhile, Moderna is also focusing on increasing its manufacturing capacity for its COVID-19 vaccine as well as for investigational booster doses.
The company announced a new agreement with its existing Switzerland-based partner, Lonza, for supply of drug substance for an additional 300 million doses of its updated booster variant vaccine candidate annually, following a potential authorization. Moderna has also signed a similar agreement with Spain-based ROVI for another 300 million doses of booster vaccine.
The company has also signed several fill/finish agreements with multiple companies to support manufacturing services and supply packaging for COVID-19 vaccine. It signed an agreement for similar services with Thermo Fisher Scientific (TMO - Free Report) to support the production of hundreds of millions of doses that will start in the third quarter of 2021.
Moderna’s stock has gained 76.7% in the year so far against the industry's decline of 4.1%.
We remind investors that mRNA-1273 achieved an efficacy rate of 94.1% during the primary efficacy analysis of the phase III COVE study evaluating it in adult patients. Meanwhile, the vaccine achieved 100% efficacy in adolescent patients in a phase II/III study. Another phase II/III study is evaluating mRNA-1273 in in children aged six months to less than 12 years.
The company is also developing booster vaccine candidates targeting different variants of coronavirus and a refrigeration-stable COVID-19 vaccine candidate, mRNA-1283, to facilitate easier distribution and administration.
Zacks Rank
Moderna currently carries 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 >>
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.
It’s a little-known chemical company that’s up 65% over last year, yet still dirt cheap. With unrelenting demand, soaring 2022 earnings estimates, and $1.5 billion for repurchasing shares, retail investors could jump in at any time.
This company could rival or surpass other recent Zacks’ Stocks Set to Double like Boston Beer Company which shot up +143.0% in little more than 9 months and NVIDIA which boomed +175.9% in one year.
Free: See Our Top Stock and 4 Runners Up >>
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