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Moderna (MRNA) RSV Jab For Older Adults Gets FDA Breakthrough Tag
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Moderna, Inc.(MRNA - Free Report) announced that the FDA has granted breakthrough therapy designation to its mRNA vaccine candidate for respiratory syncytial virus (RSV), mRNA-1345 for treatment in adults aged 60 years or older to prevent RSV-associated lower respiratory tract disease (RSV-LRTD). This designation was granted by the FDA based on positive top-line data from the pivotal phase III study, ConquerRSV, to test the efficacy of the vaccine candidate.
In the past year, Moderna’s share rose by 4.7% against the industry’s decline of 10.4%.
Image Source: Zacks Investment Research
Moderna’s vaccine candidate, mRNA-1345, previously received Fast Track designation by the FDA back in August 2021 and with the Breakthrough Designation in place, Moderna is looking forward to submitting a biological license application (BLA) for the vaccine candidate in the first half of 2023.
The ConquerRSV, phase III study evaluated the effectiveness of the candidate, mRNA-1345, against RSV-LRTD as defined by two or more symptoms. The study met its primary efficacy endpoints which were vaccine efficacy (VE) of 83.7% against RSV-LRTD as defined by two or more symptoms and VE of 82.4% in RSV-LRTD as defined by three or more symptoms.
The candidate was overall well tolerated without any clinically significant safety issues. The most common adverse effects observed were injection site pain, fatigue, headache, myalgia and arthralgia. In some (4% for mRNA-1345 and 2.8% for placebo) of the patient population, severe systemic adverse reactions were observed.
The study is currently ongoing and Moderna will be reporting updated findings at the time of regulatory submission.
With over 5.2 million cases in adults aged 60 years or older annually, RSV is an extremely contagious seasonal respiratory virus that causes LRTD and pneumonia. RSV has a death rate of 6,000-10,000 older adults in the United States annually. In addition to complications, RSV ignites underlying medical conditions, such as asthma and COPD leading to acute myocardial infarction, stroke and long-term decline of respiratory functions.
In the dearth of treatment for RSV, there is a lucrative market opportunity for Moderna. However, there are some other prominent players like Sanofi SA (SNY - Free Report) , AstraZeneca PLC (AZN - Free Report) and GSK ADR (GSK - Free Report) in this field.
AstraZeneca and partner Sanofi’s BLA for nirsevimab for the prevention of RSV-LRTD in newborns and infants is under priority review with the FDA. The FDA is expected to give its decision on the BLA in the third quarter of 2023. Nirsevimab was approved by the European Commission for the prevention of RSV-LRTD in newborns and infants in November 2022.
The vaccine will be marketed by the trade name of Beyfortus. The approval was based on MELODY phase III, MEDLEY phase II/III and phase IIb studies conducted by AstraZeneca and partner Sanofi.
GSK’s RSV vaccine candidate for older adults is under priority review with the FDA. The PDUFA date is May 3, 2023. The BLA is based on positive data from a prespecified interim analysis of the pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase III study conducted by GSK. In the European Union, GSK’s RSV vaccine candidate for older adults is under review with a decision expected in the third quarter of 2023.
Image: Shutterstock
Moderna (MRNA) RSV Jab For Older Adults Gets FDA Breakthrough Tag
Moderna, Inc.(MRNA - Free Report) announced that the FDA has granted breakthrough therapy designation to its mRNA vaccine candidate for respiratory syncytial virus (RSV), mRNA-1345 for treatment in adults aged 60 years or older to prevent RSV-associated lower respiratory tract disease (RSV-LRTD). This designation was granted by the FDA based on positive top-line data from the pivotal phase III study, ConquerRSV, to test the efficacy of the vaccine candidate.
In the past year, Moderna’s share rose by 4.7% against the industry’s decline of 10.4%.
Image Source: Zacks Investment Research
Moderna’s vaccine candidate, mRNA-1345, previously received Fast Track designation by the FDA back in August 2021 and with the Breakthrough Designation in place, Moderna is looking forward to submitting a biological license application (BLA) for the vaccine candidate in the first half of 2023.
The ConquerRSV, phase III study evaluated the effectiveness of the candidate, mRNA-1345, against RSV-LRTD as defined by two or more symptoms. The study met its primary efficacy endpoints which were vaccine efficacy (VE) of 83.7% against RSV-LRTD as defined by two or more symptoms and VE of 82.4% in RSV-LRTD as defined by three or more symptoms.
The candidate was overall well tolerated without any clinically significant safety issues. The most common adverse effects observed were injection site pain, fatigue, headache, myalgia and arthralgia. In some (4% for mRNA-1345 and 2.8% for placebo) of the patient population, severe systemic adverse reactions were observed.
The study is currently ongoing and Moderna will be reporting updated findings at the time of regulatory submission.
With over 5.2 million cases in adults aged 60 years or older annually, RSV is an extremely contagious seasonal respiratory virus that causes LRTD and pneumonia. RSV has a death rate of 6,000-10,000 older adults in the United States annually. In addition to complications, RSV ignites underlying medical conditions, such as asthma and COPD leading to acute myocardial infarction, stroke and long-term decline of respiratory functions.
In the dearth of treatment for RSV, there is a lucrative market opportunity for Moderna. However, there are some other prominent players like Sanofi SA (SNY - Free Report) , AstraZeneca PLC (AZN - Free Report) and GSK ADR (GSK - Free Report) in this field.
AstraZeneca and partner Sanofi’s BLA for nirsevimab for the prevention of RSV-LRTD in newborns and infants is under priority review with the FDA. The FDA is expected to give its decision on the BLA in the third quarter of 2023. Nirsevimab was approved by the European Commission for the prevention of RSV-LRTD in newborns and infants in November 2022.
The vaccine will be marketed by the trade name of Beyfortus. The approval was based on MELODY phase III, MEDLEY phase II/III and phase IIb studies conducted by AstraZeneca and partner Sanofi.
GSK’s RSV vaccine candidate for older adults is under priority review with the FDA. The PDUFA date is May 3, 2023. The BLA is based on positive data from a prespecified interim analysis of the pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase III study conducted by GSK. In the European Union, GSK’s RSV vaccine candidate for older adults is under review with a decision expected in the third quarter of 2023.
Zacks Rank
Moderna currently holds a Zacks Rank #4 (Sell).
You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.