Moderna’s mRNA-1010 was expected to contribute $1 billion to the company’s coffers by 2028. That plan is now out the window after the FDA refused to even look at the application.
Moderna’s plan to reach breakeven status by 2028 has been imperiled by the FDA’s surprise rejection of the flu vaccine mRNA-1010, which had been expected to contribute to billions in expected revenue along with the combo flu/COVID vaccine mRNA-1083.
“In our view. U.S. sales of these products were expected to be meaningful contributors to 2027 and 2028 revenue,” William Blair wrote in a note to investors Wednesday.
Moderna was stunned by the decision of Center for Biologics Evaluation and Research head Vinay Prasad to refuse to review the application for mRNA-1010. In an unusual step, the regulator personally signed the rejection and appears to have overruled others at the agency who felt the application should be accepted for review.
Prasad, in his letter to Moderna, said that the control vaccines used for the clinical data in the mRNA-1010 package “does not reflect the best-available standard of care.” Health and Human Services spokesperson Andrew Nixon backed Prasad up, saying that Moderna “refused to follow very clear FDA guidance from 2024 to test its product in a clinical trial against a CDC-recommended flu vaccine to compare safety and efficacy.” Moderna maintains that the FDA agreed to its use of already-approved flu vaccines as comparators.
On Wednesday, Moderna’s stock fell 9% after news broke of the refusal-to-file letter and by Thursday morning was trading at $40.08.
Without a near term regulatory path for the flu shot, Moderna may have to find a new path to profitability.
Vaccine Uncertainty
Moderna’s revenues soared in the early years of the COVID-19 pandemic, peaking at $4.9 billion in the fourth quarter of 2021, as the world scrambled to get the company’s mRNA-based vaccine. But as vaccinations rates have dwindled in the U.S. over the past few years, Moderna’s earnings have too. The company has consistently been in the red for the last few quarters, but, through aggressive cost cutting and the addition of new products to the portfolio, Moderna had planned to be back in the black by 2028.
In its 2025 third quarter earnings, Moderna reported a decline of $200 million, an improvement over $800 million lost in the second quarter of the year. MRNA-1010, the company’s next-generation influenza vaccine, was supposed to be a big part of the plan to return to profitability, along with mRNA-1083.
Then came the startling news earlier this week, with Prasad overruling agency staff in denying Moderna the opportunity of even a review for mRNA-1010.
William Blair sounded a troubled note, saying that after the news of the refusal they were reworking their models of Moderna’s future potential earnings on the fly. “This is a substantial hit to the probability of success for mRNA-1010, and in turn mRNA-1083’s (combo flu/COVID vaccine) U.S. approvability,” they wrote in a note to investors on Wednesday.
In the event that the FDA requires a new study, it’s unclear what Moderna will do, as the company last month elected to stop running new vaccine trials, at least for infectious disease. “You cannot make a return on investment if you don’t have access to the U.S. market,” CEO Stéphane Bancel said at the World Economic Forum.
Return to Profitability
Analysts at Jefferies had expected both mRNA-1010 and mRNA-1083, once approved, to each hit sales of $1 billion per year at their peak, which would hypothetically cover Moderna’s losses from recent quarters and put the company back into profitability. Moderna notably paused development of mRNA-1083 last year until mRNA-1010 was approved, in the hopes that approval of the flu vaccine would strengthen the case for the combination shot.
Moderna is planning to market mRNA-1010 in other parts of the world, and the path to approval outside the U.S. seems less obstructed. “We continue to expect approval of mRNA-1010, and potentially a path forward for mRNA-1083, in ex-U.S. geographies, but premium pricing will be difficult here, which further pressures 2028 breakeven guidance,” the William Blair analysts wrote.
Jefferies analysts agreed, expecting to see approvals in Canada, the EU and Australia for both mRNA-1010 and mRNA-1083, according to a Wednesday note. And Moderna has taken the important step of diversifying its pipeline outside of just the approved COVID-19 vaccine Spikevax, with an RSV vaccine, plus pipeline assets for norovirus, a handful of treatments for cancers like solid tumors, lymphoma and melanoma, and even rare diseases like propionic acidemia and methylmalonic acidemia.
In the meantime, Moderna’s 2026 outlook remains the same as before the FDA rejection, since the vaccines were not expected to bring revenues until 2027 and 2028, according to Jefferies. “But we’d imagine it could impact management’s 2028 cash breakeven guidance (still achievable though)—as we viewed mRNA-1010 (and secondarily mRNA-1083) as a core growth driver starting in 2027-28.”
Moderna will report fourth quarter and full-year 2025 earnings on Friday morning, where the FDA’s actions will likely be the headline.