Novavax Inc NVAX
Novavax Inc (Nasdaq: NVAX) is an infectious disease drug developer. Its lead program, COVID-19-Influenza Combination (CIC) and stand-alone influenza vaccine candidates (Matrix-M adjuvanted), is in Phase 3 for COVID-19 and influenza prevention in adults 65 and older. Its next catalyst on record is Nuvaxovid: Manufacturing technology transfer to Sanofi complete ($75M milestone) (2027).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: Nuvaxovid — Manufacturing technology transfer to Sanofi complete ($75M milestone) (2027). 3 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Nuvaxovid Phase 4 postmarketing commitment trial (run on behalf of Sanofi, BLA holder) | COVID-19 prevention, ages 50-64 without high-risk conditions | vaccine | Approved |
| CIC and stand-alone influenza vaccine candidates (Phase 3 immunogenicity/safety trial) | COVID-19 / influenza prevention, adults 65+ | vaccine | Phase 3 |
| C. difficile colitis vaccine candidate | C. difficile colitis | vaccine | Pre-clinical |
| varicella-zoster virus (shingles) vaccine | shingles | vaccine | Pre-clinical |
| RSV vaccine | respiratory syncytial virus | vaccine | Pre-clinical |
Recent results and decisions
- Nov 6, 2025positive Sanofi reported preliminary positive immunogenicity and safety Phase 1/2 data for Nuvaxovid combined with Fluzone High-Dose and with Flublok (October 2025); both programs hold FDA Fast Track.
In October 2025, Sanofi reported preliminary positive immunogenicity and safety Phase 1/2 data for Nuvaxovid™ in combination with both Fluzone High-Dose and Flublok.
Filing - Nov 6, 2025approval FDA approved the Nuvaxovid 2025-2026 Formula, with six-month shelf life in a pre-filled syringe (August 2025).
In August 2025, the FDA approved the Nuvaxovid 2025-2026 Formula for the prevention of COVID-19 in individuals 65 years of age and older, or 12 years through 64 years of age with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.
Filing
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
- Moderna, Inc. MRNA
- Vaxcyte, Inc. PCVX
- Vir Biotechnology, Inc. VIR
- 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.