Moderna, Inc. (MRNA) saw its stock price surge 5.28% during pre-market trading on Wednesday.

The significant upward movement follows the company's announcement that the U.S. Food and Drug Administration (FDA) has agreed to initiate a review of its investigational seasonal influenza vaccine, mRNA-1010. This decision marks a reversal from the regulator's initial stance, where it had issued a Refusal-to-File letter citing flaws in the trial design. Moderna submitted an amended application seeking full approval for adults aged 50 to 64 and accelerated approval for those 65 and older.

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 5, 2026, for its decision. If approved, the mRNA-based flu shot could be available as early as the 2026/27 influenza season. The positive regulatory development in the U.S., coupled with the news that Bernstein raised its price target on Moderna to $45 from $35, fueled investor optimism leading to the pre-market rally.