Moderna Stock Surges As Federal Health Regulators Clear Milestone Older Adult Flu Vaccine Data

Key Stats for Moderna Stock

• Price change for Moderna stock: 6%
• $MRNA Share Price as of Jun. 16: $55
• 52-Week High: $60
• $MRNA Stock Price Target: $43

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What Happened?

Moderna (MRNA) stock is surging for a fifth straight day after FDA staff reviewers published briefing documents suggesting that immunogenicity data from Moderna’s flu shot, mFlusiva, may support effectiveness in adults 65 and older.

That’s a meaningful shift. Just a few months ago, the FDA had initially rejected Moderna’s flu vaccine application over concerns about trial design — specifically that the company didn’t use the preferred higher-dose flu vaccine as the control arm for patients 65 and over.

The agency later reversed course after Moderna agreed to amend its application. Now, with the briefing documents published ahead of Thursday’s independent advisory panel meeting, the market is reading the tone as favorable.

Jefferies analyst Andrew Tsai called the assessment positive and projected $750 million in combined U.S. flu and COVID-flu combo vaccine sales by 2030.

The panel will vote Thursday on whether mFlusiva’s benefits outweigh its risks for adults 50 and older.

If approved, it would become the first mRNA-based seasonal flu vaccine in the United States. A final FDA decision is expected by August 5.

FDA staff did note some limitations. The vaccine has only been studied during one flu season, and immunocompromised and very frail older adults were excluded from trials.

Moderna has agreed to run an additional study in the 65-plus age group if approval is granted for that population.

Beyond the flu vaccine, Moderna stock is also getting a lift from a broader pipeline story.

The company recently received EU approval for mCOMBRIAX, its flu-plus-COVID combination vaccine — the first of its kind in the world.

It also appointed a new Chief Commercial Officer, Ester Banque, to lead upcoming product launches globally.

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What the Market Is Telling Us About Moderna Stock

Moderna stock has now gained meaningfully over five sessions.

The FDA briefing documents gave investors the clearest signal yet that the flu vaccine review is back on track after months of regulatory turbulence.

With a PDUFA date of August 5 and potential pivotal data readouts for its cancer therapy, Intismeran, and rare disease program also expected in 2026, Moderna stock is being priced with increasing optimism around a multi-product future.

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Disclaimer:

Please note that the articles on TIKR are not intended to serve as investment or financial advice from TIKR or our content team, nor are they recommendations to buy or sell any stocks. We create our content based on TIKR Terminal’s investment data and analysts’ estimates. Our analysis might not include recent company news or important updates. TIKR has no position in any stocks mentioned. Thank you for reading, and happy investing!