Moderna's norovirus vaccine misses early efficacy bar; flu shot nears FDA decision

Moderna reported on July 31, 2026 that its Phase 3 norovirus vaccine study of mRNA-1403 did not meet statistical criteria for early success at a Phase 3 interim analysis.¹ The company said the study is continuing in blinded fashion while it works to add an additional patient cohort.¹

On the regulatory side, Moderna's seasonal flu candidate mRNA-1010, branded mFLUSIVA, got a unanimous recommendation from the FDA's Vaccines and Related Biological Products Advisory Committee ahead of an August 5 PDUFA goal date.¹ The FDA has set that same August 5, 2026 date as the formal decision deadline for mRNA-1010. Separately, the company's flu-COVID combination shot, mRNA-1083, has EU marketing authorization as mCOMBRIAX and is under review in Japan, Canada and Australia, while Moderna awaits further guidance from the FDA on refiling its U.S. submission.¹

In oncology, Moderna and partner Merck are running nine total Phase 2 and Phase 3 trials of intismeran autogene (mRNA-4157) across melanoma, non-small cell lung cancer, bladder cancer and renal cell carcinoma.¹ The Phase 3 adjuvant melanoma study, along with Phase 2 studies in renal cell and bladder cancer, is fully enrolled, with adjuvant melanoma data expected potentially in 2026.¹ In rare disease, the propionic acidemia candidate mRNA-3927 has reached its enrollment target in a registrational study, with potential data expected in 2026.¹

On finances, Moderna held $6.9 billion in cash, cash equivalents and investments as of June 30, 2026, down from $7.5 billion at the end of the first quarter.¹ The company paid $950 million in July 2026 tied to a litigation settlement announced earlier in the year.¹ Moderna raised its year-end cash guidance, now projecting $4.7 to $5.2 billion in year-end cash and investments, an improvement of about $0.2 billion from its prior estimate.¹