mRNA-1403
- Generic Name
- mRNA-1403
FDA Halts Moderna's Norovirus Vaccine Trial Following Guillain-Barré Case
• The U.S. FDA has placed a clinical hold on Moderna's late-stage norovirus vaccine trial (mRNA-1403) after a reported case of Guillain-Barré syndrome.
• British pharmaceutical giant GSK faces market pressure as Citadel takes a significant short position worth 305 million pounds.
• U.S. bird flu response efforts face challenges amid administrative changes, while USDA grants conditional approval for Zoetis' avian influenza vaccine.
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's mRNA Norovirus Vaccine Candidate Enters Phase 3 Trial Amidst Rising Cases
• Moderna's norovirus vaccine candidate, mRNA-1403, is undergoing a Phase 3 clinical trial, Nova 301, with results expected as early as late 2025 or 2026.
• The trial aims to enroll 25,000 adults to assess the vaccine's safety and efficacy against multiple norovirus genotypes, including those not directly targeted by the vaccine.
• Norovirus is a highly contagious virus causing vomiting and diarrhea, leading to significant morbidity and mortality, especially among young children and older adults.
• Moderna's mRNA technology offers a potential advantage in rapidly adapting the vaccine to address evolving norovirus strains, with the goal of reducing symptom severity and hospitalizations.
Moderna and MSD Launch Phase III Trial of mRNA-4157 Plus Keytruda for NSCLC
• Moderna and MSD have initiated a Phase III clinical trial, INTerpath-009, to evaluate mRNA-4157 (V940) in combination with Keytruda for non-small cell lung cancer (NSCLC).
• The global, double-blind, randomised trial will involve 680 participants with Stage II, IIIA, or IIIB (N2) NSCLC who did not achieve a pathological complete response after initial treatment.
• mRNA-4157 is an investigational individualized neoantigen therapy that uses synthetic mRNA to code for up to 34 neoantigens based on the patient's tumor mutational signature.
• This trial is part of a broader program exploring mRNA-4157 with Keytruda across various cancer types, including melanoma, renal cell carcinoma, and urothelial carcinoma.
Moderna's mRNA Norovirus Vaccine Enters Phase 3 Trial
• Moderna's mRNA-1403 norovirus vaccine has entered a pivotal Phase 3 trial, evaluating its efficacy, safety, and immunogenicity in adults.
• The global trial, named Nova 301, aims to enroll approximately 25,000 participants, focusing on adults aged 60 years and older.
• mRNA-1403 is a trivalent vaccine designed to protect against multiple norovirus genotypes, addressing a significant public health concern.
• Interim Phase 1/2 data showed promising safety and immunogenicity, supporting the Phase 3 trial's initiation and potential for regulatory submission in 2026.
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.
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