The FDA declined to accept Moderna’s application for its mRNA influenza vaccine, an unexpected regulatory rebuff that has rippled through biotech markets. STAT’s reporting captured industry concern that the decision represents a tougher stance from regulators on novel mRNA uses beyond COVID-19. Moderna’s leadership has said the company still expects growth but acknowledged the setback could complicate its path to break-even. Financial coverage noted Moderna’s executives are reassessing timelines and guidance, and investors are parsing whether the setback signals shifting review standards for mRNA vaccines and other platform extensions.