The FDA refused to accept Moderna’s next‑generation mRNA influenza vaccine for review, a regulatory rebuke that the company says clouds its path to break‑even cash flow and forces a reprioritization of programmes. Coverage and analysis show the refusal stems from agency questions about the submission package and broader uncertainty in the FDA’s engagement on respiratory vaccine filings. Moderna has already cut R&D spending and wound down several late‑stage respiratory trials; the agency’s decision amplifies a strategic shift toward oncology and non‑seasonal vaccines. Company commentary and market reactions indicate investors and management are reassessing timelines and revenue assumptions tied to the flu franchise.