Moderna, Inc. (MRNA) shares surged 5.28% intraday, driven by a major regulatory milestone for the company's vaccine portfolio.
The rally followed the company's announcement that its seasonal influenza vaccine, mFLUSIVA, has officially received U.S. Food and Drug Administration (FDA) approval. This marks the first mRNA-based vaccine to enter the flu market and represents Moderna's fourth FDA-cleared product in the United States. The approval covers use in adults aged 50 and above, with the vaccine expected to become available for the 2026-2027 respiratory virus season.
The clearance serves as a significant achievement for Moderna, coming after a period of rare public disagreement with FDA regulators. The vaccine is also currently under regulatory review in Australia, Canada, and Europe, suggesting potential for further upside from global commercialization.
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