Moderna Inc. shares advanced approximately 5% in post-market trading on Friday, reaching $42.23, following the release of its fourth-quarter financial results. The biotech firm reported revenue of $678 million for the quarter, surpassing analyst expectations, though it recorded a net loss of $2.11 per share. Concurrently, the company reaffirmed its growth projections for the 2026 fiscal year.
Regulatory Hurdle for Flu Vaccine Program
The positive earnings momentum was tempered by a significant regulatory development. Moderna disclosed that the U.S. Food and Drug Administration (FDA) issued a refusal-to-file letter for its mRNA-1010 seasonal influenza vaccine candidate. This decision represents a setback for one of the company's key near-term commercial opportunities. In response, Moderna has formally requested a Type A meeting with the FDA to clarify the agency's concerns and determine the necessary steps to resubmit the application.
CEO Stéphane Bancel addressed the situation, cautioning that prolonged regulatory uncertainty could challenge U.S. leadership in innovative medicine. The company has countered specific technical feedback, noting that the FDA had previously approved the clinical trial design in question.
International Progress and Financial Outlook
While facing headwinds in the United States, Moderna reported more favorable regulatory progress abroad. Review processes for the seasonal flu vaccine are now underway with health authorities in the European Union, Canada, and Australia, with potential approvals possible starting in 2026. The company's combined flu and COVID-19 vaccine, mRNA-1083, is also under review in Europe and Canada.
Financially, Moderna highlighted substantial cost-cutting measures, having reduced annual operating expenses by roughly $2.2 billion for 2025. Looking ahead to 2026, Bancel expressed confidence, stating the company is "poised to deliver up to 10 percent revenue growth." This optimism is fueled by its next-generation COVID vaccine and new international agreements. The company anticipates the U.S. will account for about half of its total revenue this year, a decrease from approximately 62% in the prior year, indicating a strategic shift toward diversifying its geographic sales base.
Pipeline Developments and Market Context
Beyond its respiratory portfolio, Moderna pointed to several anticipated milestones in 2026. A Phase 3 trial for a norovirus vaccine has completed patient enrollment, with results expected next year. Additionally, pivotal Phase 3 data for its personalized cancer vaccine, developed in partnership with Merck & Co., in adjuvant melanoma are also slated for 2026.
The path forward, however, presents challenges. A delayed U.S. launch for its flu and combination shots could pressure near-term revenue. Moderna's own guidance indicates that its year-end cash and investment balance for 2026 is projected to be lower than the 2025 closing figure, as continued research and development spending impacts the balance sheet.
With U.S. markets closed for the Presidents' Day holiday on Monday, investor focus will intensify when regular trading resumes on Tuesday. Market participants will be keenly awaiting any updates regarding the scheduling of the critical FDA meeting and further signals on the international regulatory reviews that are now central to Moderna's near-term growth strategy.
