Moderna Has Some Key Approvals Ahead. Is the Stock a Buy?

Shares of Moderna (NASDAQ: MRNA) jumped during the COVID-19 pandemic, but when its COVID-19 vaccine revenue dried up, the stock slumped. However, the company has recently shown it isn't a one-trick pony by using its messenger ribonucleic acid (mRNA) platform to expand its business. Investors have noticed, and the pharmaceutical stock is up more than 100% so far this year.

Because Moderna is trading at a premium price-to-sales ratio relative to its current revenue, buying the stock now is essentially a bet that its upcoming clinical data and Food and Drug Administration (FDA) approvals will successfully unlock the commercial viability of its broader mRNA pipeline.

Here are three reasons to buy Moderna stock.

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1. Moderna has near-term portfolio diversification

Moderna is aggressively trying to replace lost COVID-19 vaccine revenue by moving into multivalent and seasonal respiratory markets. The immediate catalyst is mFlusiva, Moderna's investigational mRNA-based seasonal influenza vaccine, which fared well in a phase 3 trial.

The FDA's target action date for the stand-alone flu vaccine is Aug. 5, following highly positive briefing documents submitted to its advisory committee. If approved, the vaccine could be available for the 2026–2027 flu season. It's not a slam dunk, as an advisory committee recently cast doubt on the methodology used in the study, though it also said it found no major deficiencies in the vaccine's efficacy.

There's also optimism regarding Moderna's flu-plus-COVID-19 combination vaccine after the vaccine, in a phase 3 trial, did better than the current stand-alone vaccines for both viruses.

Last month, the European Commission approved the vaccine, called mCOMBRIAX, which aims to simplify immunization for adults aged 50 and older by combining protection against influenza and COVID-19.

Bundling the vaccines removes a massive logistical friction point. Patients who are already sitting in a pharmacy or doctor's office chair for their annual flu shot can check both boxes at once, boosting compliance with the COVID-19 booster without requiring extra public outreach.

2. Moderna is developing personalized cancer vaccines

The most transformative upside for Moderna isn't in respiratory viruses; it's if its mRNA platform can be used to treat cancer. Moderna, in partnership with Merck, is developing intismeran autogene (mRNA-4157), an individualized cancer vaccine. The therapy uses mRNA to instruct a patient's own immune system to target specific mutations found only on their tumor cells.

In January, Moderna presented stellar five-year phase 2 data in patients with high-risk melanoma, showing sustained efficacy when combined with Keytruda. Crucially, pivotal phase 3 data readouts are expected later this year, which could pave the way for its first oncology product launch and completely redefine the company's valuation.

3. Moderna has a massive commercial expansion and runway

Moderna is actively transforming its internal structure to prepare for up to three new product launches between 2027 and 2028, spanning infectious diseases (including a novel norovirus vaccine), intismeran, and rare diseases (such as its therapeutic for propionic acidemia). To manage this, it recently overhauled leadership, appointing a new veteran chief commercial officer to execute global launches.

There are some obvious risks for Moderna. In the first quarter, it reported revenue of $389 million, up 260%, year over year. However, it also reported an earnings per share (EPS) loss of $3.40, compared with $2.52 in the first quarter of 2025.

The quarter was impacted by a one-time $878 million litigation loss. Excluding that item, the company's adjusted EPS was a loss of $1.18, compared to a loss of $0.88 in the same quarter a year ago.

Moderna is obviously still burning cash on its research and development efforts, but it has $7.5 billion in cash and little debt, giving it a comfortable multiyear runway to achieve its stated goal of a companywide breakeven by 2028.

James Halley has no position in any of the stocks mentioned. The Motley Fool has positions in and recommends Merck and Moderna. The Motley Fool has a disclosure policy.