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Moderna (MRNA) Posts Pipeline Progress, Secures Blackstone Funding
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Shares of Moderna (MRNA - Free Report) rose 3% on Wednesday after management announced positive clinical updates at its Vaccines Day Event, highlighting its pipeline progress.
While the company provided an update on multiple pipeline candidates, it announced its decision to advance three vaccines to pivotal late-stage development. These include mRNA-1189 (for Epstein-Barr virus [EBV]), mRNA-1468 (for Varicella-Zoster virus [VZV]) and mRNA-1405 (for norovirus).
The decision to advance these candidates is based on data from separate early-stage clinical studies on these vaccines. Data from these studies showed that the vaccines were immunogenic and well-tolerated among the study participants.
Moderna is currently evaluating multiple therapies in late-stage development, which include mRNA-1647 (for cytomegalovirus [CMV]), mRNA-4157 (individualized neoantigen therapy [INT]) and mRNA-1083 (a combination vaccine targeting both COVID-19 and influenza).
Moderna’s top line is largely dependent on its COVID-19 vaccine, whose sales have declined significantly worldwide. Moving another three vaccines to late-stage development brings Moderna a step closer to having multiple products on the market. Management believes that the company’s vaccine portfolio targets large addressable markets with an estimated total addressable market (TAM) of around $52 billion for infectious disease vaccines.
Alongside the press release, Moderna also announced that it has entered into a funding agreement with Blackstone Life Sciences. Per the agreement terms, Blackstone will fund up to $750 million to advance the company’s influenza program in return for potential milestone payments and low single-digit royalties.
Year to date, Moderna’s shares have risen 11.2% compared with the industry’s 0.6% growth.
Image Source: Zacks Investment Research
Earlier this week, Moderna reported positive results from a pivotal phase III study evaluating mRNA-1283, its next-generation refrigerator-stable COVID-19 vaccine, in individuals aged 12 years and older. The study achieved its primary endpoint, showing that individuals who received mRNA-1283 generated a higher immune response compared with Moderna’s previously-approved bivalent Omicron BA.4/BA.5-targeting COVID vaccine.
The above results intend to reinforce confidence in mRNA-1083, which is a combined formulation of mRNA-1283 and influenza vaccine mRNA-1010.
MRNA also intends to initiate a regulatory filing with the FDA for mRNA-1010 as a standalone influenza vaccine before year-end. Last year, management reported encouraging data from a late-stage immunogenicity study (P303) and a separate phase I/II head-to-head study evaluating this flu vaccine. Participants treated with mRNA-1010 elicited higher immune responses across all four A and B strains of influenza compared with the licensed vaccines marketed by GSK and Sanofi.
Moderna anticipates an FDA approval for its RSV vaccine mRNA-1345 for use in older adults aged 60 years and older. A final decision is expected before May 12. If approved, mRNA-1345 could be Moderna’s second product launch, whose commercial launch is expected in the third quarter of 2024. Moderna is also working on expanding the use of mRNA-1345 in pediatric populations.
Management is on track to report data on late-stage studies evaluating mRNA-1647 and mRNA-1083 later this year.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share (EPS) have risen from 22 cents to 30 cents. During the same period, EPS estimates for 2025 have improved from 32 cents to 50 cents. Year to date, shares of ADMA have risen 48.5%.
Earnings of ADMA Biologics beat estimates in three of the last four quarters while meeting the same on one occasion. ADMA delivered a four-quarter average earnings surprise of 85.00%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 EPS have risen from $4.06 to $4.43. Meanwhile, during the same period, EPS estimates for 2025 have improved from $4.80 to $5.04. Year to date, shares of ANIP have risen 27.0%.
Earnings of ANI Pharmaceuticals beat estimates in each of the last four quarters. ANI delivered a four-quarter average earnings surprise of 109.06%.
In the past 60 days, Galapagos’ loss estimates for 2024 have improved from $1.68 to 39 cents. During the same period, loss estimates for 2025 have improved from 60 cents to 14 cents. Year to date, shares of Galapagos have lost 21.0%.
Galapagos’ earnings beat estimates in three of the trailing four quarters while missing the mark on one occasion. On average, GLPG’s four-quarter earnings surprise was 91.97%.
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Moderna (MRNA) Posts Pipeline Progress, Secures Blackstone Funding
Shares of Moderna (MRNA - Free Report) rose 3% on Wednesday after management announced positive clinical updates at its Vaccines Day Event, highlighting its pipeline progress.
While the company provided an update on multiple pipeline candidates, it announced its decision to advance three vaccines to pivotal late-stage development. These include mRNA-1189 (for Epstein-Barr virus [EBV]), mRNA-1468 (for Varicella-Zoster virus [VZV]) and mRNA-1405 (for norovirus).
The decision to advance these candidates is based on data from separate early-stage clinical studies on these vaccines. Data from these studies showed that the vaccines were immunogenic and well-tolerated among the study participants.
Moderna is currently evaluating multiple therapies in late-stage development, which include mRNA-1647 (for cytomegalovirus [CMV]), mRNA-4157 (individualized neoantigen therapy [INT]) and mRNA-1083 (a combination vaccine targeting both COVID-19 and influenza).
Moderna’s top line is largely dependent on its COVID-19 vaccine, whose sales have declined significantly worldwide. Moving another three vaccines to late-stage development brings Moderna a step closer to having multiple products on the market. Management believes that the company’s vaccine portfolio targets large addressable markets with an estimated total addressable market (TAM) of around $52 billion for infectious disease vaccines.
Alongside the press release, Moderna also announced that it has entered into a funding agreement with Blackstone Life Sciences. Per the agreement terms, Blackstone will fund up to $750 million to advance the company’s influenza program in return for potential milestone payments and low single-digit royalties.
Year to date, Moderna’s shares have risen 11.2% compared with the industry’s 0.6% growth.
Image Source: Zacks Investment Research
Earlier this week, Moderna reported positive results from a pivotal phase III study evaluating mRNA-1283, its next-generation refrigerator-stable COVID-19 vaccine, in individuals aged 12 years and older. The study achieved its primary endpoint, showing that individuals who received mRNA-1283 generated a higher immune response compared with Moderna’s previously-approved bivalent Omicron BA.4/BA.5-targeting COVID vaccine.
The above results intend to reinforce confidence in mRNA-1083, which is a combined formulation of mRNA-1283 and influenza vaccine mRNA-1010.
MRNA also intends to initiate a regulatory filing with the FDA for mRNA-1010 as a standalone influenza vaccine before year-end. Last year, management reported encouraging data from a late-stage immunogenicity study (P303) and a separate phase I/II head-to-head study evaluating this flu vaccine. Participants treated with mRNA-1010 elicited higher immune responses across all four A and B strains of influenza compared with the licensed vaccines marketed by GSK and Sanofi.
Moderna anticipates an FDA approval for its RSV vaccine mRNA-1345 for use in older adults aged 60 years and older. A final decision is expected before May 12. If approved, mRNA-1345 could be Moderna’s second product launch, whose commercial launch is expected in the third quarter of 2024. Moderna is also working on expanding the use of mRNA-1345 in pediatric populations.
Management is on track to report data on late-stage studies evaluating mRNA-1647 and mRNA-1083 later this year.
Moderna, Inc. Price
Moderna, Inc. price | Moderna, Inc. Quote
Zacks Rank & Key Picks
Moderna currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the overall healthcare sector include ADMA Biologics (ADMA - Free Report) , ANI Pharmaceuticals (ANIP - Free Report) and Galapagos (GLPG - Free Report) , each sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ADMA Biologics’ 2024 earnings per share (EPS) have risen from 22 cents to 30 cents. During the same period, EPS estimates for 2025 have improved from 32 cents to 50 cents. Year to date, shares of ADMA have risen 48.5%.
Earnings of ADMA Biologics beat estimates in three of the last four quarters while meeting the same on one occasion. ADMA delivered a four-quarter average earnings surprise of 85.00%.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2024 EPS have risen from $4.06 to $4.43. Meanwhile, during the same period, EPS estimates for 2025 have improved from $4.80 to $5.04. Year to date, shares of ANIP have risen 27.0%.
Earnings of ANI Pharmaceuticals beat estimates in each of the last four quarters. ANI delivered a four-quarter average earnings surprise of 109.06%.
In the past 60 days, Galapagos’ loss estimates for 2024 have improved from $1.68 to 39 cents. During the same period, loss estimates for 2025 have improved from 60 cents to 14 cents. Year to date, shares of Galapagos have lost 21.0%.
Galapagos’ earnings beat estimates in three of the trailing four quarters while missing the mark on one occasion. On average, GLPG’s four-quarter earnings surprise was 91.97%.