Moderna, Inc. (MRNA) announced that the U.S. FDA has agreed to initiate the review of its BLA for mRNA-1010, the company's investigational seasonal influenza vaccine, following a recent Type A meeting with the agency.
The FDA had previously issued a Refusal-to-File (RTF) letter, prompting Moderna to propose a revised regulatory approach. The company submitted an amended application seeking full approval for adults aged 50 to 64 and accelerated approval for adults 65 and older, along with a post-marketing requirement to conduct an additional study in older adults.
The FDA has now accepted the BLA for review and assigned a PDUFA goal date of August 5, 2026. Pending approval, mRNA-1010 could become available in the United States for adults 50 years and older, including adults 65 and above, for the 2026/2027 flu season.
Moderna noted that mRNA-1010 is also under review in Europe, Canada, and Australia, with additional submissions planned in 2026. The company expects the first potential approvals for the vaccine later this year, subject to ongoing regulatory evaluations.CEO Stéphane Bancel said the company appreciated the FDA's constructive engagement and looks forward to potentially offering a new flu vaccine option for U.S. adults later in 2026.
MRNA has traded between $22.28 and $55.20 over the past year. The stock closed Tuesday's trading at $43.93, up 4.03%. In pre-market trading on Wednesday, MRNA rose to $48.00 up 8.06%.
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