FDA Makes U-Turn Again On Moderna New Flu Vaccine Review, Stock Soars

Moderna Inc. (NASDAQ:MRNA) shares are up on Wednesday as the company has received positive news regarding its investigational flu vaccine, mRNA-1010.

The stock’s movement comes after the U.S. Food and Drug Administration (FDA) notified Moderna that its biologics license application for mRNA-1010 will proceed to review, adding pressure as broader markets experienced mixed trading.

Following a Type A meeting, the FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 5 for mRNA-1010, which is aimed at adults aged 50 and older.

To advance the review, Moderna proposed a regulatory pathway based on age, seeking full approval for adults 50 to 64 years of age and accelerated approval for adults 65 and older, along with a post-marketing requirement to conduct an additional study in older adults.

Pending review and FDA approval, mRNA-1010 would be available for U.S. adults 50 years of age and older, including adults 65 and older, for the 2026/2027 flu season.

The FDA’s acceptance of the biologics license application marks a significant step for Moderna, as mRNA-1010 has now been accepted for review in multiple regions, including the U.S., Europe, Canada, and Australia.

The company plans further submissions in 2026, with expectations for potential approvals in the same year, subject to regulatory reviews.

U-Turn

Last week, the FDA issued a refusal-to-file letter for mRNA-1010, citing the choice of a standard-dose seasonal influenza vaccine as a comparator as the sole reason for the refusal.

Moderna reported a fourth-quarter loss of $2.11, beating the expected loss of $2.59, lower than a loss of $2.91 a year ago.

The COVID-19 vaccine maker reported quarterly sales of $678 million, topping the expected $626.097 million.

Moderna is targeting up to 10% revenue growth from $1.94 billion in 2025 and expects the 2026 revenue split to be approximately 50% U.S. and approximately 50% international.

Technical Analysis

Currently, the stock is trading 6.6% above its 20-day simple moving average (SMA) and 49.6% above its 100-day SMA, demonstrating longer-term strength. Over the past 12 months, shares have increased by 22.88% and are currently positioned closer to their 52-week highs than lows.

The RSI is at 58.53, which is considered neutral territory, indicating that the stock is neither overbought nor oversold. Meanwhile, MACD is at 1.1302, below its signal line at 1.7713, suggesting bearish pressure on the stock.

The combination of neutral RSI and bearish MACD suggests mixed momentum for the stock.

• Key Resistance: $55.00
• Key Support: N/A

Analyst Consensus & Recent Actions

The stock carries a Hold Rating with an average price target of $35.31. Recent analyst moves include:

• Goldman Sachs: Neutral (Raises Target to $41.00) (February 17)
• RBC Capital: Sector Perform (Raises Target to $30.00) (February 17)
• Evercore ISI Group: In-Line (Raises Target to $35.00) (February 17)

Benzinga Edge Rankings

Below is the Benzinga Edge scorecard for Moderna, highlighting its strengths and weaknesses compared to the broader market:

• Momentum: Strong (Score: 86.29) — Stock is outperforming the broader market.

The Verdict: Moderna’s Benzinga Edge signal reveals a classic ‘High-Flyer’ setup. While the Momentum (86.29) confirms the strong trend, investors should remain vigilant as the stock navigates potential volatility ahead of its earnings report.

MRNA Price Action: Moderna shares were up 5.77% at $46.46 at the time of publication on Wednesday, according to Benzinga Pro data.

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