Moderna Inc (NASDAQ:MRNA, XETRA:0QF) announced that the US Food and Drug Administration (FDA) will initiate review of its investigational seasonal influenza vaccine, mRNA-1010, following a Type A meeting between the company and the agency.
Shares of Moderna added 6.5% at about $47 on the update.
The review follows a prior Refusal-to-File (RTF) letter from the FDA. In response, Moderna proposed a revised regulatory approach seeking full approval for adults aged 50 to 64 and accelerated approval for adults 65 and older, along with a post-marketing study requirement for older adults.
The FDA has accepted Moderna’s biologics license application (BLA) for review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026. If approved, mRNA-1010 would be available for US adults 50 and older, including those 65 and older, for the 2026/2027 flu season.
“We appreciate the FDA's engagement in a constructive Type A meeting and its agreement to advance our application for review,” Moderna CEO Stéphane Bancel said in a statement.
“Pending FDA approval, we look forward to making our flu vaccine available later this year so that America’s seniors have access to a new option to protect themselves against flu.”
Moderna has also submitted mRNA-1010 for review in Europe, Canada, and Australia, with additional submissions planned for 2026. The company expects the first potential approvals later this year, subject to ongoing regulatory assessments.
Jefferies analysts highlighted that Moderna addressed the FDA’s RTF letter for mRNA-1010 within two weeks, leading to the agency assigning an August 5, 2026, PDUFA date. They noted that “1010 could actually contribute to US sales as early as 2026,” potentially supporting Moderna’s guidance for up to 10% year-over-year revenue growth. They modeled US flu and flu/COVID combo sales of $750 million by 2030.
The analysts also noted the broader pipeline, stating that by 2027-28, Moderna could be launching more than seven products across respiratory, oncology, and rare disease indications. They wrote that continued cost reductions could allow the company to reach cash breakeven by 2028, with 2026 cash burn expected to range from $2.1 billion to $2.6 billion.
Regarding the regulatory context, Jefferies noted that the initial RTF reflected the FDA’s concerns over Moderna’s choice of a standard-dose comparator in the pivotal Phase III trial. By proposing an age-based pathway, Moderna addressed the agency’s concerns, “seeking full approval for adults 50-64, where standard-dose Fluarix is an accepted comparator, and an accelerated approval in adults ≥65, with a post-marketing study in older adults.”
The analysts concluded that mRNA-1010’s review and potential US launch could serve as a core revenue driver for 2026-28, while ex-US submissions in the EU, Canada, and Australia could further contribute to sales in 2027.
Jefferies added that the flu/COVID combo vaccine could gain EU approval by year-end 2026, covering a total addressable market of approximately $1.7 billion.