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Can Moderna (MRNA) Diversify Beyond Its COVID-19 Jab Sales?
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Moderna (MRNA - Free Report) is focused on expanding its portfolio of marketed products, including its COVID-19 vaccine, whose sales have declined in recent quarters.
Being one of the first-ever COVID-19 vaccine developers, Moderna generated robust product sales that helped the company transform from a clinical-stage pharmaceutical company to a commercial one, with solid sales.
The higher-than-expected product sales helped the company boost its cash resources. MRNAis developing more than 30 mRNA-based investigational candidates in multiple stages of clinical studies.
Last month, Moderna initiated regulatory submissions for its mRNA-based RSV vaccine mRNA-1345 for use in older adults (aged 60 years and older) in several markets, including the United States, Europe and Australia. A potential launch is expected next year. If approved, mRNA-1345 could be Moderna’s second product launch.
Apart from RSV, the company is currently evaluating three candidates in late-stage studies — mRNA-1010 (influenza vaccine), mRNA-1647 (cytomegalovirus (CMV) vaccine), and mRNA-4157/V940 [individualized neoantigen therapy (INT)].
Earlier this month, Moderna announced that it completed enrolment in the phase III immunogenicity study (P303) evaluating an enhanced formulation of mRNA-1010, which is expected to improve immune responses againstthe influenza B strain. Data from the P303 study is also likely to support the company’s regulatory filing for the vaccine’s accelerated approval. Data from the P303 study is expected before September 2023-end. Given the company’s accelerated timetable for mRNA-1010, we expect mRNA-1010 to be the company’s third product launch, expected in the next year.
Alongside the second-quarter results, management reported that it completed over 80% of enrolment in the pivotal phase III study evaluating its CMV vaccine mRNA-1647.
Moderna and partner Merck (MRK - Free Report) reported new data from phase IIb evaluating mRNA-4157 in melanoma indication in June. Data from the study showed that mRNA-4157combined with Merck’s Keytruda reduced the risk of distant metastasis or death by 65% compared with participants treated with Merck’s Keytruda alone. The study previously achieved its primary endpoint of recurrence-free survival. Based on these positive results, Moderna/Merck initiated the phase III study on mRNA-4157 in melanoma patients last month.
Based on the encouraging clinical progress of the above candidates, management is gearing up for the commercial launches of the above candidates over the next three years.
Apart from the above candidates, Moderna is also evaluating mRNA-based investigational candidates in multiple mid-stage and early-stage stages of clinical studies, targeting various indications, includingzika virus and propionic acidemia.
Despite new product launch expectations and pipeline progress, Moderna continues to develop its COVID-19 vaccine to target new and evolving virus variants. Though the company expects to generate revenue from COVID-19 vaccine product sales, demand is expected to be more seasonal.
In June, Moderna submitted a regulatory application to the FDA seeking approval for mRNA-1273.815, a monovalent vaccine designed to target the XBB descendent lineage viruses. Management even claims that it has built an ample supply for mRNA-1273.815 and is ready to ship the same doses for the upcoming fall vaccination season, provided that the FDA authorizes the vaccine for use.
However, the company’s target markets are highly competitive. Moderna’s COVID-19 vaccine already faces stiff competition from Pfizer (PFE - Free Report) /BioNTech‘s (BNTX - Free Report) mRNA-based COVID-19 vaccine. Pfizer/BioNTech also submitted regulatory filings with the FDA for their updated monovalent vaccine targeting the XBB lineages.
About the RSV vaccine, Pfizer was one of the first developers to receive FDA approval for its RSV vaccine Abrysvo for use in older adults. Pfizer is also seeking label expansion approval from the FDA for using Abrysvo in pregnant women to help prevent the disease in infants. A final decision is expected before this month’s end.
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Can Moderna (MRNA) Diversify Beyond Its COVID-19 Jab Sales?
Moderna (MRNA - Free Report) is focused on expanding its portfolio of marketed products, including its COVID-19 vaccine, whose sales have declined in recent quarters.
Being one of the first-ever COVID-19 vaccine developers, Moderna generated robust product sales that helped the company transform from a clinical-stage pharmaceutical company to a commercial one, with solid sales.
The higher-than-expected product sales helped the company boost its cash resources. MRNAis developing more than 30 mRNA-based investigational candidates in multiple stages of clinical studies.
Last month, Moderna initiated regulatory submissions for its mRNA-based RSV vaccine mRNA-1345 for use in older adults (aged 60 years and older) in several markets, including the United States, Europe and Australia. A potential launch is expected next year. If approved, mRNA-1345 could be Moderna’s second product launch.
Apart from RSV, the company is currently evaluating three candidates in late-stage studies — mRNA-1010 (influenza vaccine), mRNA-1647 (cytomegalovirus (CMV) vaccine), and mRNA-4157/V940 [individualized neoantigen therapy (INT)].
Earlier this month, Moderna announced that it completed enrolment in the phase III immunogenicity study (P303) evaluating an enhanced formulation of mRNA-1010, which is expected to improve immune responses againstthe influenza B strain. Data from the P303 study is also likely to support the company’s regulatory filing for the vaccine’s accelerated approval. Data from the P303 study is expected before September 2023-end. Given the company’s accelerated timetable for mRNA-1010, we expect mRNA-1010 to be the company’s third product launch, expected in the next year.
Alongside the second-quarter results, management reported that it completed over 80% of enrolment in the pivotal phase III study evaluating its CMV vaccine mRNA-1647.
Moderna and partner Merck (MRK - Free Report) reported new data from phase IIb evaluating mRNA-4157 in melanoma indication in June. Data from the study showed that mRNA-4157combined with Merck’s Keytruda reduced the risk of distant metastasis or death by 65% compared with participants treated with Merck’s Keytruda alone. The study previously achieved its primary endpoint of recurrence-free survival. Based on these positive results, Moderna/Merck initiated the phase III study on mRNA-4157 in melanoma patients last month.
Based on the encouraging clinical progress of the above candidates, management is gearing up for the commercial launches of the above candidates over the next three years.
Apart from the above candidates, Moderna is also evaluating mRNA-based investigational candidates in multiple mid-stage and early-stage stages of clinical studies, targeting various indications, includingzika virus and propionic acidemia.
Despite new product launch expectations and pipeline progress, Moderna continues to develop its COVID-19 vaccine to target new and evolving virus variants. Though the company expects to generate revenue from COVID-19 vaccine product sales, demand is expected to be more seasonal.
In June, Moderna submitted a regulatory application to the FDA seeking approval for mRNA-1273.815, a monovalent vaccine designed to target the XBB descendent lineage viruses. Management even claims that it has built an ample supply for mRNA-1273.815 and is ready to ship the same doses for the upcoming fall vaccination season, provided that the FDA authorizes the vaccine for use.
However, the company’s target markets are highly competitive. Moderna’s COVID-19 vaccine already faces stiff competition from Pfizer (PFE - Free Report) /BioNTech‘s (BNTX - Free Report) mRNA-based COVID-19 vaccine. Pfizer/BioNTech also submitted regulatory filings with the FDA for their updated monovalent vaccine targeting the XBB lineages.
About the RSV vaccine, Pfizer was one of the first developers to receive FDA approval for its RSV vaccine Abrysvo for use in older adults. Pfizer is also seeking label expansion approval from the FDA for using Abrysvo in pregnant women to help prevent the disease in infants. A final decision is expected before this month’s end.