MRNA Stock Clocks Best Week In Over 4 Years On FDA Advisory Committee Endorsement For Flu Vaccine

Jefferies noted that FDA decisions aligned with advisory committee recommendations 84% of the time between 2020 and 2025.

• The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 9–0 that the benefits of mRNA-1010, also known as mFLUSIVA, outweigh its risks for adults aged 50-64.
• The FDA is now considering the non-binding recommendations as part of its review of Moderna’s Biologics License Application.
• The FDA is slated to decide on the application by August 5.

Shares of Moderna (MRNA) rose about 3% on Thursday after an FDA advisory committee voted unanimously in favor of the company’s investigational mRNA seasonal flu vaccine for older adults.

The stock gained over 28% this week, marking its best week since March 2022.

The Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted 9-0 that the benefits of mRNA-1010, also called mFLUSIVA, outweigh its risks for adults aged 50-64. The panel also voted 9-0 in favor of the vaccine for people aged 65 or above during its June 18 meeting.

“We appreciate the thoughtful review by the members of VRBPAC,” said Moderna CEO Stéphane Bancel. “We believe mRNA-1010 has the potential to provide an important new option for seasonal flu prevention.”

What's Next For MRNA’s Vaccine?

The advisory committee reviewed data from Moderna’s late-stage program to derive its conclusion. The FDA is now considering the non-binding recommendations as part of its review of Moderna’s Biologics License Application. The FDA is slated to decide on the application by August 5.

Moderna submitted the Biologics License Application for the vaccine on Dec. 5, and the FDA filed it on Feb. 17 after a brief refusal, which was resolved with a revised application.

Wall Street Weighs In

Jefferies reiterated a ‘Hold’ rating and $45 price target on Moderna after the votes. The firm stated that FDA decisions aligned with advisory committee recommendations 84% of the time between 2020 and 2025. Analysts said their confidence has increased in an eventual approval for ages 50 and older, though meaningful flu revenues are unlikely before 2027. Jefferies models $750 million in combined U.S. flu and flu/covid combo sales by 2030.

Earlier this week, Moderna announced organizational changes to prepare for multiple product launches expected in 2027 and 2028. CEO Stéphane Bancel said the moves will strengthen execution as the company prepares to manage three commercial franchises while advancing its mRNA pipeline. Potential launches during this period include the seasonal flu vaccine, a flu-COVID combination vaccine, and a norovirus vaccine.

How Did MRNA Retail Traders React?

On Stocktwits, retail sentiment around MRNA stock stayed within the ‘extremely bullish’ territory over the past 24 hours, while message volume rose from ‘high’ to ‘extremely high’ levels.

A Stocktwits user said that they are bullish on an approval.

Another user said that they see a lot more upside coming for the stock.

According to data from Koyfin, two of the 22 analysts covering MRNA rate it ‘Buy’ or higher, while 17 rate it ‘Hold’ and three rate it ‘Sell’ or ‘Strong Sell.’ The 12-month average price target on the stock is $43.30, representing a potential downside of about 32% from the last close.

MRNA stock has gained over 107% this year.

For updates and corrections, email newsroom[at]stocktwits[dot]com.<