Key insights
- The European Commission approved Moderna's flu-COVID combo vaccine, mCOMBRIAX, for adults 50+. This approval, based on positive Phase 3 trial results, could provide a revenue boost for Moderna, though profitability concerns remain. While the stock has surged, InvestingPro analysis suggests it may be overvalued. The approval is a positive catalyst, but its impact on US equities is limited.
CAMBRIDGE, Mass. - Moderna Inc. (NASDAQ:MRNA) announced today that the European Commission has granted marketing authorization for mCOMBRIAX, an mRNA combination vaccine for prevention of influenza and COVID-19 in individuals 50 years of age and older. The approval comes as Moderna’s stock has surged 117% over the past year, bringing its market capitalization to $21 billion, though the company continues to face profitability challenges with revenue of $1.94 billion in the last twelve months.
The authorization follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use and is valid in all 27 European Union member states, as well as Iceland, Liechtenstein and Norway. mCOMBRIAX represents Moderna’s fourth authorized product, according to a company press release.
The approval is based on results from a Phase 3 clinical trial involving approximately 8,000 adults across two age cohorts. The randomized, observer-blind study evaluated the safety and immunogenicity of mRNA-1083 in adults 65 years and older, and adults 50 to 64 years of age.
The trial compared mRNA-1083 to co-administered licensed vaccines. In the older cohort, it was compared to Efluelda, a high-dose influenza vaccine, and Spikevax, Moderna’s COVID-19 vaccine. In the younger cohort, it was compared to Fluarix, a standard-dose influenza vaccine, and Spikevax.
All primary endpoints demonstrating non-inferiority of immune responses were met. Following a single dose, mRNA-1083 elicited statistically significantly higher immune responses against three influenza virus strains (A/H1N1, A/H3N2, and B/Victoria) and against SARS-CoV-2 in both age cohorts.The regulatory win offers a potential revenue catalyst for Moderna, which according to InvestingPro analysis remains unprofitable with a negative gross profit margin. The platform’s Fair Value assessment currently suggests the stock is overvalued at current levels. Investors can access detailed financial health scores and over 10 additional ProTips for MRNA, along with comprehensive Pro Research Reports covering 1,400+ US stocks.
The vaccine demonstrated an acceptable safety and tolerability profile, with the majority of solicited adverse reactions being grade 1 or 2 in severity and consistent with licensed vaccines used in the trial.
mCOMBRIAX will be made available across the European Union, subject to national regulatory and access procedures. The company stated it will work with national authorities to support local access and implementation.
In other recent news, Moderna reported promising results from a Phase 1/2 study of its investigational cancer therapy, mRNA-4359, combined with pembrolizumab. This combination therapy achieved an overall response rate of 83% in patients with advanced melanoma, with a disease control rate of 92%. Additionally, Moderna has reached a significant settlement with Arbutus Biopharma and Genevant Sciences to resolve patent disputes related to its infectious disease vaccines. The agreement includes a $950 million payment, with no future royalties owed on the products in question. Furthermore, Moderna has agreed to a settlement of up to $2.25 billion to address allegations of unauthorized use of lipid nanoparticle technology in its COVID vaccine. Jefferies has reiterated a Hold rating on Moderna stock following these developments, maintaining a price target of $37. Meanwhile, OpenAI has launched GPT-Rosalind, an AI model aimed at advancing research in biology and drug discovery.
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