Biotech Stocks Axsome and Moderna Back Bull Case With FDA Wins

An all-weather bet on two very different biotechs

In early August, a Motley Fool column made a bold claim: two biotech stocks, Axsome Therapeutics and Moderna, could keep rising even if the broader market fell into a bear market.1 The author's argument was simple. Companies with real scientific breakthroughs, products already on the market and regulatory milestones close at hand should be less tied to macroeconomic and geopolitical swings than the average stock.13 Two months later, there is enough new information to test that claim. Moderna's regulatory bet has paid off. Axsome's commercial results so far fit the thesis, but the company is still losing money, and "no matter what the market does" depends on that changing.

Readers should know that the Motley Fool holds positions in both companies and recommends both. The author disclosed no personal holdings.23 That does not make the analysis wrong. It does mean the case was made by an interested party, so it is worth checking against the companies' filings and independent reporting.

Moderna: the catalyst arrived

The Moderna half of the argument depended on mFLUSIVA, the company's mRNA influenza vaccine. When the column ran, an FDA advisory panel had unanimously found that the vaccine's benefits outweighed its risks, and the author called approval very likely.1 The column also credited regulatory progress on the vaccine for Moderna beating the market this year.4

Approval came on August 5, 2026, one day after the column was published. mFLUSIVA was cleared for adults 50 and older and became the first mRNA-based flu vaccine on the U.S. market.812 Coverage agrees on the main facts. The approval for ages 50 to 64 rests on a phase 3 trial of 40,805 adults in 11 countries. In that trial, the vaccine showed 26.6% relative efficacy against a standard-dose flu shot.911 NBC News rounded the result to about 27% better than a standard shot.15

The details of the approval complicate the bull case somewhat. For people 65 and older, the group the column said is most at risk, the FDA granted only accelerated approval. That decision was based on immune-response data from a separate trial of 2,992 U.S. adults compared against a high-dose flu vaccine, and Moderna must run a confirmatory study after launch.911 An HHS spokesperson said Secretary Kennedy believes mRNA products deserve extra scrutiny, and called the post-market requirements some of the strongest the agency has imposed.15

The approval also came after a difficult review. The FDA initially refused to accept the application in February 2026 because Moderna had compared its vaccine against a standard-dose shot rather than what the agency called the best available care for older adults. It did not cite any problem with safety or efficacy.12 Moderna then split its request by age group, and the FDA accepted that revised plan.12

The sources also differ slightly on a basic number. The column called mFLUSIVA Moderna's fifth approved product.1 Trade coverage, following Moderna's own announcement, says it is the company's fourth FDA-approved product and fifth worldwide.911 The difference is small but tells investors something. Moderna's U.S. lineup is Spikevax, mRESVIA, mNEXSPIKE and now mFLUSIVA.9 Its combination flu-and-COVID vaccine was approved in the European Union in April, but Moderna withdrew its U.S. application last year.15

Why the flu shot matters more than its first-season sales

Moderna needs new revenue. The column reported second-quarter revenue of just $145 million, up 2% from a year earlier, and a loss of $1.97 per share. It blamed weak demand for the COVID vaccine.1 One season of flu shot sales will not change that much by itself. The vaccine enters a market where high-dose and adjuvanted vaccines for older adults are already well established.9

The larger value is what the approval shows about Moderna's platform. Experts quoted by Medical News Today said the approval proves mRNA technology can work beyond COVID-19. Because mRNA vaccines can be made faster than egg-based ones, they may also match circulating flu strains more closely.7 AJMC reported that mRNA manufacturing cuts the time needed to produce a strain-matched vaccine from about six months to two or three.6 If that speed advantage holds up in real-world use, it gives Moderna an edge that established flu vaccine makers will find hard to copy.

Clinicians are less certain than investors. Some physicians called the approval encouraging but said they want another season or two of real-world data before calling it better than existing enhanced vaccines for seniors.7 Side effects were also more common. About 75% of mFLUSIVA recipients reported at least one expected short-term reaction, compared with 47% of people who got the standard vaccine, although most reactions were mild or moderate.10 For a seasonal shot that people choose each year at a pharmacy, that gap could limit uptake.

My reading is that the approval removes the biggest near-term risk to Moderna's story but does not solve its revenue problem. The column also pointed to longer-term pipeline candidates, including the personalized cancer vaccine mRNA-4157 and an HIV program.1 Those programs are what could make Moderna the long-term "wealth compounder" the author described. The flu shot mainly buys the company time to get there.

Axsome: strong sales, rising costs

Axsome is a clearer commercial story. The column cited first-quarter revenue growth of 57% to $191.2 million, alongside a wider operating loss of $63.4 million.1 The second quarter, reported on August 10, continued the trend. Net product revenue rose 46% to $218.4 million.1721 Auvelity, which treats depression and is now also approved for Alzheimer's disease agitation, brought in $180.3 million, up 51%.1619

The early launch numbers in Alzheimer's agitation support the column's view that the new label's impact had not yet appeared in the results.1 In the first eight weeks after the June launch, new Auvelity prescriptions among patients 65 and older rose 126% compared with the same period in the prior quarter.17 Coverage reached about 89% of insured lives.16 Axsome expanded its Auvelity sales force from 300 to 600 representatives, and management later raised its peak sales estimate for the drug to more than $8 billion.24

The weaknesses are also in the numbers. Investing.com reported that revenue came in slightly below Wall Street's forecast and that the loss of $0.99 per share was wider than the expected $0.85.20 Zacks reported that the loss matched its consensus estimate but that revenue missed its $225 million estimate.18 The reports disagree on how bad the earnings result was, but both show revenue falling a little short. Selling and administrative costs jumped about 60% to $208.1 million, and the net loss grew to $51.3 million.21 Migraine drug Symbravo sold only $2.3 million and fell from the previous quarter.20

Management says those costs will now level off. The CFO said selling and administrative spending should stay near the second-quarter level, while research spending rises as ADHD trials begin, and that the company should start to show operating leverage in the second half of the year.20 The pipeline adds to the outlook. The FDA has set a May 1, 2027 decision date for AXS-12 in cataplexy, and Axsome has started phase 3 trials of solriamfetol in children with ADHD.25 The column described Axsome's estimate that its full portfolio could eventually reach $18 billion in sales as optimistic but grounded in large unmet medical needs.2

The verdict

Two months on, the column's predictions about each company have mostly held up. Moderna got its approval, and Axsome kept growing quickly. But the claim that these stocks will win no matter what the market does goes too far for either company. Moderna's growth now depends on a vaccine with a conditional approval in its most important age group, launched while the federal government remains openly skeptical of mRNA. Axsome's gains depend on revenue growing faster than costs that rose 60% in a year, at a company with $319.9 million in cash and continuing losses.21

Of the two, Axsome looks like the stronger case for steady growth. Its demand comes from prescriptions and market share, not one regulatory event, and management says it holds less than a quarter of one percent of the depression market.24 Moderna is a recovery story with a working platform and a long way to go. Both are better bets than they were at the start of 2026, but in a real bear market neither should be treated as safe from losses.