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Moderna (MRNA) Begins Dosing in Study on mRNA Flu Vaccine
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Moderna, Inc. (MRNA - Free Report) announced that it has dosed the first participant in a phase I/II study which is evaluating mRNA-1010, its quadrivalent mRNA-based vaccine candidate, against seasonal influenza.
Notably, mRNA-1010 is Moderna’s first seasonal influenza vaccine candidate which has entered clinical testing for the prevention of influenza, including seasonal influenza A H1N1, H3N2 and influenza B Yamagata and Victoria.
The stratified dose-ranging study will evaluate the safety, reactogenicity and immunogenicity of mRNA-1010 in healthy adults aged 18 years and above in the United States. The company plans to enroll around 180 participants in the given study.
Moderna’s goal is to develop a respiratory vaccine for the adult population, combining seasonal flu, COVID-19 variant booster and respiratory syncytial virus.
Novavax (NVAX - Free Report) is also developing its nanoparticle seasonal influenza vaccine candidate, NanoFlu, in phase III studies. The company will file a biologics license application (“BLA”) to the FDA shortly, seeking an accelerated approval for NanoFlu.
Shares of Moderna have skyrocketed 112.4% so far this year against the industry’s decrease of 1.1%.
Image Source: Zacks Investment Research
Moderna is developing several promising mRNA candidates as therapies and vaccines targeting oncology indications and rare diseases.
The company has several mRNA-based vaccine candidates in clinical-stage development. Later in 2021, it plans on starting studies to evaluate some of its candidates – a pivotal phase III study to evaluate mRNA-1647 as a Cytomegalovirus vaccine; a mid-stage study to evaluate mRNA-1893 as Zika virus vaccine; and studies on mRNA-1644 and mRNA-1574 as HIV vaccines and mRNA-1215 as a vaccine against Nipah virus.
Meanwhile, Moderna has received approval for emergency use of its mRNA-based COVID-19 vaccine, mRNA-1273, in several countries across the world. In the first quarter of 2021, the vaccine recorded sales worth $1.73 billion.
Last month, Moderna initiated rolling submission for a BLA with the FDA seeking approval/licensure for use of mRNA-1273 in adults. A potential approval of the BLA for mRNA-1273 will allow Moderna to continue to commercialize the COVID-19 vaccine even after the emergency situation recedes with lowering of infection rates.
Incidentally, Moderna faces stiff competition from Pfizer/BioNTech (BNTX - Free Report) , AstraZeneca (AZN - Free Report) and J&J, who have also received authorization for emergency/conditional use of their respective COVID-19 vaccines in several countries.
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
Image: Shutterstock
Moderna (MRNA) Begins Dosing in Study on mRNA Flu Vaccine
Moderna, Inc. (MRNA - Free Report) announced that it has dosed the first participant in a phase I/II study which is evaluating mRNA-1010, its quadrivalent mRNA-based vaccine candidate, against seasonal influenza.
Notably, mRNA-1010 is Moderna’s first seasonal influenza vaccine candidate which has entered clinical testing for the prevention of influenza, including seasonal influenza A H1N1, H3N2 and influenza B Yamagata and Victoria.
The stratified dose-ranging study will evaluate the safety, reactogenicity and immunogenicity of mRNA-1010 in healthy adults aged 18 years and above in the United States. The company plans to enroll around 180 participants in the given study.
Moderna’s goal is to develop a respiratory vaccine for the adult population, combining seasonal flu, COVID-19 variant booster and respiratory syncytial virus.
Novavax (NVAX - Free Report) is also developing its nanoparticle seasonal influenza vaccine candidate, NanoFlu, in phase III studies. The company will file a biologics license application (“BLA”) to the FDA shortly, seeking an accelerated approval for NanoFlu.
Shares of Moderna have skyrocketed 112.4% so far this year against the industry’s decrease of 1.1%.
Moderna is developing several promising mRNA candidates as therapies and vaccines targeting oncology indications and rare diseases.
The company has several mRNA-based vaccine candidates in clinical-stage development. Later in 2021, it plans on starting studies to evaluate some of its candidates – a pivotal phase III study to evaluate mRNA-1647 as a Cytomegalovirus vaccine; a mid-stage study to evaluate mRNA-1893 as Zika virus vaccine; and studies on mRNA-1644 and mRNA-1574 as HIV vaccines and mRNA-1215 as a vaccine against Nipah virus.
Meanwhile, Moderna has received approval for emergency use of its mRNA-based COVID-19 vaccine, mRNA-1273, in several countries across the world. In the first quarter of 2021, the vaccine recorded sales worth $1.73 billion.
Last month, Moderna initiated rolling submission for a BLA with the FDA seeking approval/licensure for use of mRNA-1273 in adults. A potential approval of the BLA for mRNA-1273 will allow Moderna to continue to commercialize the COVID-19 vaccine even after the emergency situation recedes with lowering of infection rates.
Incidentally, Moderna faces stiff competition from Pfizer/BioNTech (BNTX - Free Report) , AstraZeneca (AZN - Free Report) and J&J, who have also received authorization for emergency/conditional use of their respective COVID-19 vaccines in several countries.
Zacks Rank
Moderna currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
5 Stocks Set to Double
Each was hand-picked by a Zacks expert as the #1 favorite stock to gain +100% or more in 2020. Each comes from a different sector and has unique qualities and catalysts that could fuel exceptional growth.
Most of the stocks in this report are flying under Wall Street radar, which provides a great opportunity to get in on the ground floor.
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