Moderna, Inc. MRNA
Moderna, Inc. (Nasdaq: MRNA) is an oncology drug developer. Its lead program, intismeran autogene (mRNA-4157), is in Phase 3 for melanoma (adjuvant). Its next catalyst on record is mRNA-2808: Oral presentation at ASH Annual Meeting (December 2026).
Upcoming catalysts
- December 2026mRNA-2808 — Oral presentation at ASH Annual Meeting
An abstract was accepted for oral presentation at the American Society of Hematology (ASH) Annual Meeting in December 2026.
Next further out: intismeran autogene (mRNA-4157) — Overall survival data maturity (date not stated). 3 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Spikevax | COVID-19 | RNA (siRNA/ASO/mRNA) | Approved |
| mFLUSIVA (mRNA-1010) | influenza | RNA (siRNA/ASO/mRNA) | Approved |
| intismeran autogene (mRNA-4157) | melanoma (adjuvant) | RNA (siRNA/ASO/mRNA) | Phase 3 |
| intismeran autogene (mRNA-4157) | non-small cell lung cancer (NSCLC) | RNA (siRNA/ASO/mRNA) | Phase 3 |
| norovirus vaccine | norovirus infection | RNA (siRNA/ASO/mRNA) | Phase 3 |
| seasonal flu + COVID combination vaccine | influenza + COVID-19 | RNA (siRNA/ASO/mRNA) | Phase 3 |
| CMV vaccine | cytomegalovirus | RNA (siRNA/ASO/mRNA) | Phase 2 |
| intismeran autogene (mRNA-4157) | pancreatic ductal adenocarcinoma (adjuvant) | RNA (siRNA/ASO/mRNA) | Phase 1 |
| intismeran autogene (mRNA-4157) | gastric carcinoma (perioperative) | RNA (siRNA/ASO/mRNA) | Phase 1 |
| mRNA-2808 | hematology | RNA (siRNA/ASO/mRNA) | Phase 1 |
| mRNA-1469 | bundibugyo ebolavirus | RNA (siRNA/ASO/mRNA) | Phase 1 |
| mRNA-3927 | propionic acidemia | RNA (siRNA/ASO/mRNA) | Phase 1 |
Recent results and decisions
- Nov 6, 2026negative The norovirus vaccine Phase 3 interim analysis did not meet the statistical criteria for early success, and Moderna does not plan to initiate an additional cohort this season.
Following the Phase 3 interim analysis, which did not meet the statistical criteria for early success, Moderna does not plan to initiate an additional cohort this season.
Filing - met Intismeran autogene plus KEYTRUDA reduced the risk of recurrence or death by 42% in the INTerpath-001 Phase 3 study in resected high-risk melanoma.
Intismeran autogene in combination with KEYTRUDA® (pembrolizumab) reduced the risk of recurrence or death by 42% (HR=0.58) and the risk of distant metastasis or death by 38% (HR=0.62), compared with KEYTRUDA alone, in the intention-to-treat population.
Filing - approval Moderna received U.S. FDA approval for mFLUSIVA, its seasonal influenza vaccine, for adults aged 50–64 years and accelerated approval for adults aged 65 years and older.
In August, Moderna received U.S. Food and Drug Administration (FDA) approval for mFLUSIVA®, its seasonal influenza vaccine, for adults aged 50–64 years and accelerated approval for adults aged 65 years and older, marking the Company's fifth approved product globally.
Filing
11 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 oncology companies
- Astrazeneca PLC AZN
- Gilead Sciences, Inc. GILD
- Revolution Medicines, Inc. RVMD
- Genmab A/S GMAB
- BioNTech SE BNTX
- Guardant Health, Inc. GH
- Exelixis, Inc. EXEL
- Summit Therapeutics Inc. SMMT
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.