Moderna, Inc. (MRNA) surged 5.00% in pre-market trading on Monday, extending its recent rally as investor enthusiasm over the FDA approval of its seasonal influenza vaccine, mFLUSIVA, showed no signs of cooling.
The approval, which came earlier this month, marks a historic milestone as the first mRNA-based vaccine to enter the flu market and represents Moderna's fourth FDA-cleared product in the United States. mFLUSIVA is approved for adults aged 50 and above, and the company expects availability through select retail channels in the coming weeks to cover the 2026-2027 respiratory virus season. The vaccine is also under regulatory review in Australia, Canada, and Europe, further bolstering market confidence in Moderna's mRNA platform expansion and commercialization prospects.
The regulatory green light followed an earlier setback, making the approval a significant commercial victory for the biotech firm. While some analysts, such as Bank of America, have maintained cautious ratings, the broader market sentiment has turned increasingly positive on the stock's ability to diversify beyond its COVID-19 vaccine portfolio.