Moderna, Inc. MRNA
Moderna, Inc. (Nasdaq: MRNA) is an infectious disease drug developer. Its lead program, Spikevax (mRNA-1273), is in Phase 3 for COVID-19. Its next catalyst on record is intismeran autogene: Phase 3 melanoma data (2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: intismeran autogene — Phase 3 melanoma data (2026). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Spikevax | COVID-19 | vaccine | Approved |
| mNEXSPIKE | COVID-19 | vaccine | Approved |
| mRESVIA | RSV | vaccine | Approved |
| mRNA-1010 | seasonal influenza | vaccine | Phase 3 |
| intismeran autogene | melanoma | RNA (siRNA/ASO/mRNA) | Phase 3 |
| mRNA-1403 | norovirus | vaccine | Phase 3 |
| mRNA-3927 | propionic acidemia | RNA (siRNA/ASO/mRNA) | Phase 2 |
Recent results and decisions
- Jul 31, 2026negative Norovirus Phase 3 did not meet statistical criteria for early success at interim analysis; trial continues blinded and an additional cohort will be enrolled.
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.
Filing - May 1, 2026approval European Commission approved mNEXSPIKE COVID-19 vaccine (ex-US regulator).
Advanced infectious disease portfolio with key regulatory milestones in the EU, including approval of mNEXSPIKE and mCOMBRIAX, Moderna’s flu plus COVID combination vaccine
Filing - May 1, 2026approval European Commission granted marketing authorization for mCOMBRIAX flu+COVID combination vaccine (ex-US regulator).
The Company has received European Commission marketing authorization for mCOMBRIAX in the EU and its mRNA-1083 regulatory filings are under review in Canada and Australia.
Filing
15 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 infectious disease companies
- Gilead Sciences, Inc. GILD
- GSK plc GSK
- Vaxcyte, Inc. PCVX
- Vir Biotechnology, Inc. VIR
- Novavax Inc NVAX
- Sinovac Biotech Ltd SVA
- CorMedix Inc. CRMD
- Valneva SE VALN
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.