What Happened?
Shares of biotechnology company Moderna (NASDAQ: MRNA) jumped 5.9% in the afternoon session after the U.S. Food and Drug Administration (FDA) reversed an earlier decision and agreed to review the company'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.
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What Is The Market Telling Us
Moderna’s shares are extremely volatile and have had 50 moves greater than 5% over the last year. In that context, today’s move indicates the market considers this news meaningful but not something that would fundamentally change its perception of the business.
The previous big move we wrote about was 5 days ago when the stock gained 5.6% on the news that a softer-than-expected inflation report fueled hopes for interest rate cuts by the Federal Reserve. The January Consumer Price Index (CPI), a key measure of inflation, rose by 0.2%, which was less than economists had forecast, with the annual rate cooling to 2.4%. This encouraging data increased market expectations for the Fed to begin cutting interest rates as early as June. The news prompted a rally in Treasuries as their yields fell. While the market's reaction was initially described as a "bumpy ride" due to concerns in other sectors, the favorable inflation data ultimately helped calm Wall Street. Lower inflation is a key prerequisite for the central bank to ease its monetary policy, which is generally supportive of stock valuations.
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. Investors who bought $1,000 worth of Moderna’s shares 5 years ago would now be looking at an investment worth $274.94.
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