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
catalyst calendar
MODERNA INC · Data as of 2026-10-25
2026
The Company has filed and is targeting 2026 approvals in Australia, the EU, Japan and Taiwan.Source filing
2026
Moderna's RSV vaccine, mRESVIA®, is in an ongoing Phase 3 heterologous revaccination study with data expected in 2026.Source filing
2026
Submissions in additional countries are planned for 2026.Source filing
2026
Moderna expects potential data in 2026.Source filing
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
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
Oct 25
Abstract 3151P: Adjuvant intismeran autogene plus FOLFIRINOX in resectable pancreatic ductal adenocarcinoma: results from a phase I study Session Type/Title : Poster - Pancreatic cancer Date & Time : Sunday, October 25, 12:00-12:45 PM CET Presenter: David J. Pinato (London, United Kingdom)Source filing