Moderna’s norovirus vaccine mRNA-1403 failed to hit statistical significance in a Phase 3 interim analysis, the company disclosed in its second-quarter 2026 earnings report on July 31. The NOVA 301 trial has enrolled nearly 38,000 people, stays blinded, and now needs a third season of data to clear the bar.
President Stephen Hoge blamed a “unique outbreak of a different set of strains” in the trial’s first season. He compared it to flu vaccines, which often need multiple seasons to accrue enough cases. Fair point, but it’s still a miss investors were pricing for good news.
Moderna shrugged it off anyway. The company reiterated its up-to-10% 2026 revenue growth target and posted $145 million in quarterly revenue, a beat, driven by ex-U.S. sales of Spikevax and mNexspike. It also trimmed R&D 7% to $651 million after killing an inhaled cystic fibrosis candidate with Vertex and shelving a methylmalonic acidemia asset pending Phase 1/2 data.
Here’s the read: Moderna is running a portfolio triage play, cutting weaker bets to protect the one program that matters most right now. That’s mFLUSIVA, the mRNA flu vaccine that cleared a unanimous 9-0 VRBPAC vote in June after FDA briefly refused to even review the filing in February. It would be Moderna’s fifth approved product and the first mRNA flu shot on the U.S. market.
The FDA’s PDUFA date lands August 5. A yes turns a rough quarter into a franchise-launch story. A no, after the agency already reversed itself once, would sting a lot more than a slow norovirus readout.
— Sarah Chen