mRNA-3927
- Generic Name
- mRNA-3927
- Drug Type
- Biotech
- Background
mRNA-3927 is an investigational mRNA therapy that consists of two mRNAs that encode for the alpha and beta subunits of the mitochondrial enzyme propionyl-CoA carboxylase (PCC) encapsulated within a lipid nanoparticle (LNP). Developed by Moderna Inc., it is being investigated for the treatment of propionic acidemia.
Moderna Reports $3.2 Billion in 2024 Revenue, Submits Three mRNA Products for Regulatory Approval
• Moderna reported $3.2 billion in total revenue for fiscal year 2024, with a net loss of $3.6 billion as the company transitions from pandemic to seasonal COVID-19 vaccine market.
• The company has submitted three investigational mRNA products for regulatory approval, including a next-generation COVID vaccine, RSV vaccine for high-risk adults 18-59, and a flu/COVID combination vaccine.
• For 2025, Moderna projects revenue between $1.5-2.5 billion and plans to reduce costs by nearly $1 billion, with an expected year-end cash balance of approximately $6 billion.
Moderna Faces Investor Concerns Despite Pipeline Progress and Cost-Cutting Efforts
• Moderna's stock has significantly dropped in 2024 due to waning COVID-19 vaccine demand, despite positive data and new approvals.
• The company is implementing substantial R&D cuts to achieve profitability by 2028, a plan that initially underwhelmed investors.
• Recent safety concerns with Moderna's RSV vaccine in younger populations have added to the company's challenges.
• Upcoming Phase III data for Moderna's cytomegalovirus vaccine is a critical catalyst that could significantly impact the stock's trajectory.
Moderna Restructures Pipeline, Prioritizes Key Approvals, and Cuts R&D Spending
• Moderna is reducing its research and development expenses by 20%, aiming for $16 billion between 2025 and 2028, to focus on profitability.
• The company is prioritizing ten product approvals by 2027, including vaccines for COVID-19, flu, and RSV, while streamlining its pipeline.
• Positive Phase 3 results were announced for Moderna's RSV vaccine in high-risk adults under 60, with plans to seek expanded FDA approval.
• Moderna is delaying its break-even goal to 2028 and anticipates 2025 sales between $2.5 billion and $3.5 billion amid shifting market dynamics.
Moderna's Combo COVID-19 and Flu Vaccine Shows Promising Results in Early Trial
• Moderna announced positive data from an early-stage study of its mRNA-based combination vaccine for COVID-19 and influenza, showing similar or stronger immune responses compared to standalone vaccines in older adults.
• The company plans to begin Phase 3 trials of the combination vaccine later this year, with regulatory approval targeted for 2025, potentially simplifying the complicated vaccination schedule for respiratory diseases.
• This development aligns with Moderna's broader respiratory franchise strategy, which expects $8-15 billion in sales by 2027 and includes successful Phase 3 results for standalone flu vaccine mRNA-1010.
Drug Development Updates
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