Moderna (MRNA 4.54%) has been on fire this year, with the biotech's shares up by 39% through Feb. 6. This isn't due to the company's financial results. Moderna has yet to release its fourth-quarter 2025 update. That's coming up on Feb. 13.
And although it provided guidance for 2025, that was months ago and wasn't nearly spectacular enough to jolt the stock this much. What's driving Moderna's performance in 2026? And should investors buy the stock before its next quarterly update? Let's take a look.
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Positive clinical developments
One of the main reasons Moderna's shares are rising is that one of the company's pipeline candidates, mRNA-4157, looks increasingly promising. Moderna is developing this investigational personalized cancer vaccine in collaboration with pharmaceutical giant Merck (MRK 0.12%). The two partners recently released five-year data from a phase 2 clinical trial in which mRNA-4157 was administered to patients with advanced melanoma in combination with Merck's Keytruda, compared with Keytruda alone.
The five-year follow-up shows that the combination of mRNA-4157 and Keytruda led to a significant reduction in disease recurrence or death compared to Keytruda alone. mRNA-4157 is being investigated in phase 2 or phase 3 studies across a range of different cancers. Progress with this pipeline program is helping boost the stock price.
Then there is the fact that in early January, Moderna announced that it had submitted its influenza vaccine candidate, mRNA-1010, to regulatory authorities for approval in adults aged 50 and older. There are already flu vaccines on the market, but their efficacy is pretty low -- typically between 40% and 60% (and sometimes much lower than that). Elderly patients are particularly at risk of developing severe cases of the flu. mRNA-1010 performed well in phase 3 studies and could help address challenges in the flu vaccine market.
NASDAQ: MRNA
Key Data Points
Will the quarterly update bring more surprises?
Moderna expects revenue between $1.6 billion and $2 billion for the full year 2025. In 2024, the company's top line came in at $3.2 billion. With the coronavirus vaccine market experiencing regulatory scrutiny in the U.S., leading to lower demand, it's not surprising to see Moderna's sales moving in the wrong direction.
In my view, Moderna's upcoming earnings report won't come with any significant surprise -- revenue could be closer to the bottom end of its guidance if the issues in the U.S. market prove even more severe than anticipated, but that won't change its long-term prospects much. So, should investors buy Moderna's shares before the quarterly report? Only if they intend to hold on to the stock for a while, regardless of which way it moves after the Feb. 13 report.
After several years of struggling with inconsistent revenue and net losses, the company is making significant pipeline progress that could help it transform its lineup and return to consistent top-line growth. The approval of mRNA-1010 and, potentially, mRNA-4157 in the future would be important catalysts for the biotech stock. Further, Moderna has a deep pipeline of innovative mRNA-based products beyond that.
The stock is still down massively over the past five years -- and it could still encounter clinical and regulatory setbacks -- but for investors comfortable with some volatility, it is worth seriously considering Moderna right now.
