Moderna Inc. (NASDAQ:MRNA) shares are up on Wednesday as the company has received positive news regarding its investigational flu vaccine, mRNA-1010.

The stock’s movement comes after the U.S. Food and Drug Administration (FDA) notified Moderna that its biologics license application for mRNA-1010 will proceed to review, adding pressure as broader markets experienced mixed trading.

Following a Type A meeting, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 5 for mRNA-1010, which is aimed at adults aged 50 and older.

To advance the review, Moderna proposed a regulatory pathway based on age, seeking full approval for adults 50 to 64 years of age and accelerated approval for adults 65 and older, along with a post-marketing requirement to conduct an additional study in older adults.

Pending review and FDA approval, mRNA-1010 would be available for U.S. adults 50 years of age and older, including adults 65 and older, for the 2026/2027 flu season.

The FDA’s acceptance of the biologics license application marks a significant step for Moderna, as mRNA-1010 has now been accepted for review in multiple regions, ...