New York, June 16, 2026, 14:06 ET
- Moderna was up about $5.06 at $57.19, with shares trading higher as SPY and QQQ slipped.
- FDA staff comments on Moderna’s mFlusiva flu vaccine came ahead of a June 18 advisory panel vote, prompting the move.
- Next up is the FDA panel meeting. The FDA is expected to make its decision by August 5.
Moderna, Inc. shares jumped Tuesday after FDA staff reviewers said data on the company’s mFlusiva flu shot “may support effectiveness” in adults 65 and up. Moderna traded at $57.19, up about 9.7%. The stock hit an intraday high of $57.36 on nearly 6.8 million shares traded. SPDR S&P 500 ETF Trust slipped 0.4%, with Invesco QQQ Trust down 1.4%.
Moderna shares jumped after investors took the FDA review to mean a lower regulatory risk for the vaccine maker’s push into respiratory vaccines outside COVID. FDA staff said immune-response data may back mFlusiva in older adults, Reuters reported. The shot also showed better relative vaccine efficacy than a standard-dose flu shot in people aged 50-64. Relative vaccine efficacy, or rVE, shows how much better one vaccine works over another in a head-to-head trial. In briefing documents, Moderna’s mRNA-1010 posted a 26.6% rVE against RT-PCR-confirmed flu-like symptoms versus standard-dose in people over 50. Reuters
mFlusiva could be the first mRNA-based seasonal flu shot in the U.S. if it gets the green light. Moderna wants full approval for adults 50 to 64 and is asking for accelerated approval for those 65 and up—this quicker path can use immune-response data but needs more confirmation later. The FDA committee votes June 18 on the benefit-risk balance, and Reuters says an FDA call may come by August 5. Jesse Goodman, the former FDA chief scientist, told Reuters the review “highlights a change in response to this specific application from a few months ago.” Jefferies’ Andrew Tsai called the review favorable and sees $750 million in U.S. sales from flu and combo COVID-flu vaccines by 2030. Reuters
Moderna bulls see the company getting closer to scaling its mRNA platform into a bigger commercial operation. Moderna on Tuesday announced new leadership moves, with Ester Banque named chief commercial officer and President Stephen Hoge increasing oversight of its infectious disease, intismeran, and rare disease portfolios. Reuters said Moderna is getting ready for possible launches in 2027 and 2028, including combo flu-COVID, seasonal flu, and norovirus vaccines. The company is also waiting for clinical milestones for intismeran and propionic acidemia. Reuters
Bear arguments remain strong. FDA staff pointed out limits in the flu vaccine data, saying it was studied for just one flu season and didn’t include immunocompromised or very frail older adults, so there’s still doubt about how it works in some high-risk groups. The FDA briefing also listed higher reported adverse reactions compared to other vaccines, although serious adverse events were about even. Biotech stocks can swing around regulatory dates since a single decision may change future revenue outlooks. The advisory vote on June 18 isn’t the last step, but it’s the next big event for investors. U.S. Food and Drug Administration
Moderna trades on catalysts, not on value at today’s levels. First-quarter revenue landed at $389 million and the company posted a $1.3 billion net loss. Loss per share was $3.40. Cash, cash equivalents and investments stood at $7.5 billion as of March 31. Moderna is targeting up to 10% revenue growth in 2026 and says year-end cash and investments should fall to $4.5 billion-$5.0 billion. With negative earnings per share, the price-to-earnings ratio isn’t useful—Moderna is still in the red. Investors have to bet on approvals, launches, and tighter expenses. The risk is clear: a bad panel readout, smaller label or softer vaccine demand could erase gains fast. accessnewswire.com
