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Moderna (MRNA) Up on Upbeat Data From Phase III Study on RSV Jab
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Shares of Moderna (MRNA - Free Report) jumped 6.5% in after-market trading on Jan 17 after management announced that the pivotal phase III ConquerRSV study evaluating mRNA-1345, its mRNA-based respiratory syncytial virus (RSV) vaccine, achieved the primary efficacy endpoints.
The ConquerRSV study, which evaluated mRNA-1345 in older adults aged 60 years and above, achieved vaccine efficacy of 83.7% against RSV-associated lower respiratory tract disease (RSV-LRTD), defined by two or more symptoms of the disease in older adults. The vaccine also achieved 82.4% efficacy against RSV-LRTD, defined by three or more symptoms of the disease. mRNA-1345 was well-tolerated and no safety concerns were identified.
Based on these results, management expects to submit for regulatory approval of mRNA-1345 in first-half 2023.
These results are based on an interim analysis of 64 cases of RSV-LRTD with two or more symptoms. While the study is still ongoing, management intends to provide an updated analysis of safety and tolerability will be provided at the time of regulatory submission.
Shares of Moderna have declined 9.6% in the past year compared with the industry’s 8.8% fall.
Image Source: Zacks Investment Research
The ConquerRSV study is one of the five ongoing studies being conducted by Moderna which is evaluating the RSV vaccine. The company is also evaluating mRNA-1345 in an early-stage study in pediatric populations. Apart from this, the vaccine is also being evaluated in combination clinical studies. Moderna is also developing a key combination respiratory vaccine candidate, mRNA-1230, as an annual vaccine against COVID-19, influenza virus and RSV in an ongoing phase I study.
Currently, there are no FDA-approved vaccines against RSV infections. Older adults are at maximum risk of getting RSV disease.
Apart from Moderna, Pfizer (PFE - Free Report) and GSK (GSK - Free Report) have also developed their own RSV vaccine candidates that are currently under FDA review.
Last month, Pfizer announced that its regulatory filing with the FDA seeking approval for its RSV vaccine candidate, RSVpreF, was granted priority review by the FDA. Pfizer’s filing seeks a review for the use of RSVpreF in older adults aged at least 60 years for the prevention of LRTI. A final FDA decision on Pfizer’s RSV vaccine is expected by May 2023.
RSVPreF3, GSK’s RSV vaccine for older adults, is also under FDA priority review, with a decision expected in May 2023. Regulatory applications seeking approval of GSK’s RSV vaccine are under review in Japan and Europe as well.
If approved, either Pfizer’s or GSK’s vaccines may be the first approved RSV vaccine in the United States.
In the past 60 days, estimates for Allogene’s 2023 loss per share have narrowed $2.84 to $2.82. Shares of Allogene have declined 41.0% in the past year.
Earnings of Allogene beat estimates in each of the last four quarters, witnessing an earnings surprise of 9.44%, on average. In the last reported quarter, Allogene’s earnings beat estimates by 6.45%.
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Moderna (MRNA) Up on Upbeat Data From Phase III Study on RSV Jab
Shares of Moderna (MRNA - Free Report) jumped 6.5% in after-market trading on Jan 17 after management announced that the pivotal phase III ConquerRSV study evaluating mRNA-1345, its mRNA-based respiratory syncytial virus (RSV) vaccine, achieved the primary efficacy endpoints.
The ConquerRSV study, which evaluated mRNA-1345 in older adults aged 60 years and above, achieved vaccine efficacy of 83.7% against RSV-associated lower respiratory tract disease (RSV-LRTD), defined by two or more symptoms of the disease in older adults. The vaccine also achieved 82.4% efficacy against RSV-LRTD, defined by three or more symptoms of the disease. mRNA-1345 was well-tolerated and no safety concerns were identified.
Based on these results, management expects to submit for regulatory approval of mRNA-1345 in first-half 2023.
These results are based on an interim analysis of 64 cases of RSV-LRTD with two or more symptoms. While the study is still ongoing, management intends to provide an updated analysis of safety and tolerability will be provided at the time of regulatory submission.
Shares of Moderna have declined 9.6% in the past year compared with the industry’s 8.8% fall.
Image Source: Zacks Investment Research
The ConquerRSV study is one of the five ongoing studies being conducted by Moderna which is evaluating the RSV vaccine. The company is also evaluating mRNA-1345 in an early-stage study in pediatric populations. Apart from this, the vaccine is also being evaluated in combination clinical studies. Moderna is also developing a key combination respiratory vaccine candidate, mRNA-1230, as an annual vaccine against COVID-19, influenza virus and RSV in an ongoing phase I study.
Currently, there are no FDA-approved vaccines against RSV infections. Older adults are at maximum risk of getting RSV disease.
Apart from Moderna, Pfizer (PFE - Free Report) and GSK (GSK - Free Report) have also developed their own RSV vaccine candidates that are currently under FDA review.
Last month, Pfizer announced that its regulatory filing with the FDA seeking approval for its RSV vaccine candidate, RSVpreF, was granted priority review by the FDA. Pfizer’s filing seeks a review for the use of RSVpreF in older adults aged at least 60 years for the prevention of LRTI. A final FDA decision on Pfizer’s RSV vaccine is expected by May 2023.
RSVPreF3, GSK’s RSV vaccine for older adults, is also under FDA priority review, with a decision expected in May 2023. Regulatory applications seeking approval of GSK’s RSV vaccine are under review in Japan and Europe as well.
If approved, either Pfizer’s or GSK’s vaccines may be the first approved RSV vaccine in the United States.
Moderna, Inc. Price
Moderna, Inc. price | Moderna, Inc. Quote
Zacks Rank & Stock to Consider
Moderna currently carries a Zacks Rank #3 (Hold). A better-ranked stock in the overall healthcare sector is Allogene (ALLO - Free Report) , which currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Allogene’s 2023 loss per share have narrowed $2.84 to $2.82. Shares of Allogene have declined 41.0% in the past year.
Earnings of Allogene beat estimates in each of the last four quarters, witnessing an earnings surprise of 9.44%, on average. In the last reported quarter, Allogene’s earnings beat estimates by 6.45%.