Moderna Inc. (MRNA) shares jumped Wednesday after the company got some very good news about its investigational flu vaccine, mRNA-1010. And by "very good," we mean the FDA decided to actually review the thing after rejecting it just last week. Talk about a turnaround.

The Food and Drug Administration notified Moderna that its biologics license application for mRNA-1010 will proceed to review, a notable development considering the regulatory whiplash everyone just experienced. Following a Type A meeting, the FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 5 for the vaccine, which targets adults aged 50 and older.

A Creative Regulatory Solution

Here's where things get interesting. To move the review forward, Moderna proposed splitting its regulatory pathway based on age. The company is seeking full approval for adults 50 to 64 years old and accelerated approval for adults 65 and older. The accelerated approval route comes with strings attached: Moderna would need to conduct an additional post-marketing study in older adults.

If everything goes according to plan and the FDA gives its blessing, mRNA-1010 would be available for U.S. adults 50 years of age and older, including those 65 and up, for the 2026/2027 flu season. The acceptance of the biologics license application represents a significant milestone 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 rolling in throughout the year, subject to regulatory reviews.

So What Happened Last Week?

The FDA issued a refusal-to-file letter for mRNA-1010 just last week, citing Moderna's choice of a standard-dose seasonal influenza vaccine as a comparator as the sole reason for the rejection. It was a pretty specific objection, and apparently one that could be addressed quickly enough to get things back on track.

Recent Financial Performance

Beyond the vaccine drama, Moderna reported a fourth-quarter loss of $2.11 per share, which actually beat the expected loss of $2.59 and was better than the $2.91 loss from a year ago. The COVID-19 vaccine maker posted quarterly sales of $678 million, topping the expected $626.097 million.

Looking ahead, 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 Picture

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

The RSI sits at 58.53, which is neutral territory, meaning the stock isn't overbought or oversold. Meanwhile, MACD is at 1.1302, below its signal line at 1.7713, suggesting some bearish pressure. The combination points to mixed momentum for the stock. Key resistance sits at $55.00.

What Analysts Are Saying

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)

Market Performance Metrics

According to momentum scoring, Moderna is showing strong performance with a score of 86.29, outperforming the broader market. The combination of strong momentum and the regulatory breakthrough creates what some might call a "high-flyer" setup, though investors should stay alert for potential volatility.

Moderna shares were up 5.77% at $46.46 at the time of publication on Wednesday.