Moderna price target lowered to $12 from $17 at Leerink

Leerink lowered the firm’s price target on Moderna (MRNA) to $12 from $17 and keeps an Underperform rating on the shares. The firm notes that after the close, Moderna announced FDA’s CBER issued a Refusal-to-File letter for flu vaccine mRNA-1010, citing use of a standard-dose comparator rather than “best-available standard of care” as the reason. Management cited this as inconsistent with the FDA’s prior written guidance during pre-Phase 3 and pre-submission meetings, where the agency explicitly stated the standard-dose comparator as acceptable even in older adults.