MRNA · 8-K · 20260731PR000147
Product / Drug Pipeline Progress
Moderna, Inc. · 2026-07-31 · Importance 30 · Surprise 42 · In source text
Moderna’s late-stage pipeline spans infectious-disease vaccines, oncology therapeutics and rare-disease treatments. The Phase 3 mRNA-1403 norovirus study did not meet statistical criteria for early success at interim analysis, and Moderna plans to enroll an additional cohort while the trial remains blinded. In oncology, nine Phase 2 and Phase 3 mRNA-4157 trials are underway across melanoma, NSCLC, bladder cancer and renal cell carcinoma, with five-year data showing a 49% reduction in recurrence or death versus KEYTRUDA alone in adjuvant melanoma. The registrational mRNA-3927 propionic-acidemia study has reached target enrollment, while the pivotal-trial decision for mRNA-3705 was deferred pending those data.
Key facts
- Moderna's propionic acidemia candidate mRNA-3927 is in a registrational study and target enrollment has been reached; Moderna expects potential data in 2026. source
- Moderna expects Phase 3 adjuvant melanoma data potentially in 2026 for intismeran. source
- Following the Phase 3 interim analysis, the mRNA-1403 trial is ongoing, remains blinded, and the Company is preparing to enroll an additional cohort. source
- Moderna's Phase 2 portion of mRNA-4359 study includes cohorts in first-line metastatic melanoma, second-line+ metastatic melanoma and first-line metastatic NSCLC. source
- Moderna deferred its decision on a pivotal trial for mRNA-3705 (MMA therapeutic) until PA registrational data readout. source
- Moderna's Phase 3 safety and efficacy study of mRNA-1403 did not meet statistical criteria for early success at the Phase 3 interim analysis. source
- Moderna presented positive five-year Phase 2b adjuvant melanoma data at the 2026 ASCO Annual Meeting showing intismeran with KEYTRUDA reduced risk of recurrence or death by 49% compared to KEYTRUDA alone. source
Impact estimates
| metric | direction | stage | expected | basis |
|---|---|---|---|---|
| revenue | positive | contingent | — | Moderna's propionic acidemia candidate mRNA-3927 is in a registrational study and target enrollment has been reached; Moderna expects… |
| revenue | positive | probable | — | Moderna expects Phase 3 adjuvant melanoma data potentially in 2026 for intismeran. |
| operating_income | negative | committed | — | Following the Phase 3 interim analysis, the mRNA-1403 trial is ongoing, remains blinded, and the Company is preparing to enroll an… |
| cash | mixed | probable | — | Moderna deferred its decision on a pivotal trial for mRNA-3705 (MMA therapeutic) until PA registrational data readout. |
| revenue | negative | probable | — | Moderna's Phase 3 safety and efficacy study of mRNA-1403 did not meet statistical criteria for early success at the Phase 3 interim… |
| revenue | positive | probable | — | Moderna presented positive five-year Phase 2b adjuvant melanoma data at the 2026 ASCO Annual Meeting showing intismeran with KEYTRUDA… |