Moderna Inc. (NASDAQ:MRNA) shares moved higher by about 2% Wednesday morning after U.S. regulators agreed to review the firm's biologics license application for its investigational seasonal influenza vaccine candidate, mRNA-1010.
The U.S. Food and Drug Administration's decision to open a formal review follows a Type A meeting between the agency and Moderna, during which the company presented a revised regulatory pathway for the vaccine. As part of the filing, the FDA set a Prescription Drug User Fee Act - PDUFA - goal date of August 5, 2026, establishing the target timeline for the agency’s review process.
Under the regulatory approach Moderna proposed, the company is seeking full approval for adults aged 50 to 64 and an accelerated approval for people 65 and older. The plan includes a commitment to perform an additional study in the older adult population as a post-marketing requirement if accelerated approval is granted. Moderna has stated that, if granted regulatory clearance, mRNA-1010 would be offered to U.S. adults aged 50 years and older for the 2026/2027 influenza season.
Stéphane Bancel, Moderna's chief executive officer, commented on the engagement with regulators: "We appreciate the FDA's engagement in a constructive Type A meeting and its agreement to advance our application for review. 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."
The agency's decision to proceed with a review follows an earlier Refusal-to-File letter issued to the company, which prompted Moderna to interact further with regulators and propose the revised pathway contained in the current filing. Moderna has indicated that mRNA-1010 has also been accepted for review by regulators in Europe, Canada, and Australia, and that additional regulatory submissions are planned through 2026.
Moderna expects the first potential approvals for the mRNA-1010 vaccine to occur in 2026, subject to the outcomes of ongoing regulatory reviews across different jurisdictions. The company has positioned the revised strategy to address differing approval standards by age cohort and to meet post-approval evidence requirements where applicable.
Market and sector implications
The acceptance of the biologics license application for review and the set PDUFA date provide a clearer regulatory timetable for Moderna and market participants tracking vaccine approvals. The development chiefly affects the biotech and pharmaceutical sectors, and has specific relevance for companies pursuing mRNA-based therapeutics and vaccines. Broader implications for healthcare providers and adult vaccination program planning hinge on the timing and outcome of regulatory decisions.