Moderna shares jump as company affirms growth outlook

Core Insights - Moderna reported better-than-expected fourth quarter sales and affirmed revenue growth estimates for 2026 despite soft demand for its COVID-19 vaccine and pushback from the FDA [1] Financial Performance - The company recorded revenue of $678 million in Q4 2025 and $1.9 billion for the entire year, figures at the higher end of projections [2] - U.S. sales more than halved between Q3 and Q4 but still accounted for over 60% of full-year revenue, aided by the launch of the COVID shot mNEXSPIKE and a strong retail market [2] Future Growth Projections - Moderna reiterated a predicted growth of 10% in 2026, primarily from international markets, accounting for a decline in COVID vaccinations and no revenue from influenza or combination shots [3] Regulatory Challenges - The combination shot and standalone flu vaccine are under review in international markets but face regulatory challenges in the U.S. [4] - Moderna received a "refuse-to-file" letter for its flu vaccine, mRNA-1010, due to issues with the comparator used in its Phase 3 trial [5] - The company has requested a Type A meeting with the FDA to discuss the decision regarding mRNA-1010 [5][6] Analyst Sentiment - Analysts express caution, with RBC Capital Markets noting skepticism about the FDA reversing its decision, while Leerink Partners views the FDA letter as indicative of pressure from current leadership [7] Market Access Advocacy - Moderna's president emphasized the importance of American seniors having access to innovations similar to other markets, highlighting the need for advanced mRNA technologies in influenza vaccine development [8]