Overview
- U.S. regulators reversed an earlier refusal and agreed to evaluate Moderna’s mRNA-1010 flu vaccine after the company outlined a revised regulatory approach.
- A prior FDA objection focused on the comparator-arm dosing used in Moderna’s study, which the company addressed in a subsequent meeting.
- An FDA decision on the flu vaccine is expected by August 5, 2026, with any launch contingent on approval.
- Moderna’s fourth-quarter results topped expectations, with EPS of -$2.11 versus -$2.62 estimated and revenue of $678 million exceeding the $662.84 million forecast.
- The stock logged a six-day advance of about 25% to roughly a $20 billion market value, as analysts raised price targets, while Moderna reiterated up to 10% revenue growth for 2026, targeted cash breakeven by 2028, and highlighted a mixed pipeline that includes a 2024 RSV approval, a recent CMV phase 3 failure, and a phase 3 oncology vaccine.