mNEXSPIKE (mRNA-1283) — NDA/BLA submission
2026
The Company has filed and is targeting 2026 approvals in Australia, the EU, Japan and Taiwan.Source filing
MRNA biotech catalysts & pipeline
MODERNA INC · Data as of 2026-10-27
Upcoming catalysts
mresvia — Clinical data readout
2026
Moderna's RSV vaccine, mRESVIA®, is in an ongoing Phase 3 heterologous revaccination study with data expected in 2026.Source filing
mRNA-1010 — NDA/BLA submission
2026
Submissions in additional countries are planned for 2026.Source filing
mRNA-3927 — Clinical data readout
2026
Moderna expects potential data in 2026.Source filing
mRNA-4359 — Clinical data readout
2026
The Phase 2 portion of the study includes cohorts in first-line metastatic melanoma, second-line+ metastatic melanoma and first-line metastatic NSCLC, and the Company expects a potential Phase 2 data readout in 2026.Source filing
mRNA-1010 — Regulatory decision
Sep 2026–Apr 2027
Moderna expects the earliest potential approvals for mRNA-1010 to begin in late 2026 or early 2027, subject to those ongoing regulatory reviews.Source filing
intismeran autogene (mRNA-4157) — Conference presentation
Oct 23–Oct 27
These late-breaking results will be presented for the first time during Presidential Symposium I at the European Society for Medical Oncology (ESMO) Congress 2026 (Presentation #LBA1), were selected for an official ESMO Press Briefing and have been accepted for publication in The New England Journal of Medicine .Source filing