The FDA issued a surprise refusal to review Moderna's mRNA flu vaccine filing. There were no safety or efficacy concerns cited, but the agency pushed back despite an earlier agreement on trial design. This is a setback for their plan to move beyond Covid vaccines, though regulators in Europe, Canada, and Australia are still reviewing the application. Moderna reported a $2.8 billion net loss for 2025 with revenue falling to $1.9 billion. Management stated this FDA delay doesn't impact their 2026 financial guidance, but it adds uncertainty to the approval timeline for their US pipeline.