FDA Reverses Decision, Agrees to Review Moderna's Seasonal Flu Vaccine Application
The FDA reversed an earlier refusal and agreed to review Moderna's seasonal flu vaccine application after the company revised its approach based on age groups, setting a decision date of August 5, 2026.
The U.S. Food and Drug Administration reversed an earlier decision and agreed to review Moderna's application for its new seasonal flu vaccine. The move came about a week after the agency had issued a "refusal to file" letter, initially declining to consider the vaccine candidate, mRNA-1010.
Following a meeting with regulators, Moderna revised its application with a new approach based on age. The company sought full approval for adults aged 50 to 64 and accelerated approval for those 65 and older. The FDA accepted the amended application and set a target decision date of August 5, 2026. If approved, Moderna aimed to make the vaccine available for the 2026-2027 flu season, removing a significant regulatory hurdle.
Shares of the biotechnology company jumped 5.9% following the announcement. Moderna is up 51.1% since the beginning of the year, but at $46.62 per share, it is still trading 10.1% below its 52-week high of $51.87 from January 2026.
Multiple analysts maintained Hold ratings on Moderna following the news. A Hold rating was maintained on February 23 with a price target of $30.00. Another Hold rating was maintained on February 13 with a price target of $30.00. The analyst consensus on Moderna is a Hold with an average price target of $36.13, representing a -28.8% downside. Another Hold rating maintained a price target of $32.25, representing a -23.63% downside.
Based on Moderna's latest earnings release for the quarter ending September 30, the company reported a quarterly revenue of $1.02 billion and a GAAP net loss of $200 million. In comparison, last year the company earned a revenue of $1.86 billion and had a net profit of $13 million.
Based on the recent corporate insider activity of 48 insiders, corporate insider sentiment is negative on the stock. This means that over the past quarter there has been an increase of insiders selling their shares in relation to earlier this year. Most recently, in December 2025, a Director sold 23,853.00 shares for a total of $703,186.44.