Vaxcyte, Inc. PCVX
Vaxcyte, Inc. (Nasdaq: PCVX) is an infectious disease drug developer. Its lead program, VAX-31, is in Phase 3 for Prevention of invasive pneumococcal disease (IPD) and pneumonia in adults. Its next catalyst on record is VAX-31 adult: Safety, tolerability and immunogenicity data from OPUS-2 and OPUS-3 studies (H1 2027).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: VAX-31 adult — Safety, tolerability and immunogenicity data from OPUS-2 and OPUS-3 studies (H1 2027). 3 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| VAX-31 (adult) | Prevention of IPD and pneumonia in adults | protein/peptide | Phase 3 |
| VAX-31 (pediatric) | Prevention of IPD in infants | protein/peptide | Phase 2 |
| VAX-24 | Prevention of IPD in infants | protein/peptide | Phase 2 |
| VAX-A1 | Prevention of disease caused by Group A Streptococcus | protein/peptide | Phase 1 |
| VAX-XL | Pneumococcal disease (third-generation PCV) | protein/peptide | Pre-clinical |
| VAX-GI | Prevention of dysentery and shigellosis (Shigella) | protein/peptide | Pre-clinical |
Recent results and decisions
- Oct 5, 2026met OPUS-1 met all prespecified co-primary endpoints: noninferiority (OPA GMR LBCI >0.667) for all 28 shared serotypes vs PCV20/PCV21, superiority for 3 unique serotypes plus 20B, and immunobridging 18-49 vs 50-64; safety similar to PCV20/PCV21. Versus PCV21 alone, serotypes 3 and 12F missed LBCI >0.667 (17 of 19 met).
VAX-31 met all prespecified co-primary immunogenicity endpoints across all age groups studied in this pivotal Phase 3 trial, providing the clinical cornerstone for our planned Biologics License Application.
Filing - met VAX-31 met all prespecified primary endpoints in OPUS-1 pivotal Phase 3 trial in adults, demonstrating noninferiority to PCV20 and PCV21 with favorable safety profile.
VAX-31 met all prespecified primary endpoints in this pivotal Phase 3 trial, which inaugurated a more stringent noninferiority standard, and we believe the results further support its potential best-in-class profile.
Filing - started VAX-A1 Phase 1 study in adults advancing to Stage 2 following completion of DSMB review of Stage 1 safety and tolerability data.
The VAX-A1 Phase 1 study initiated in June 2026 is advancing to Stage 2 following the completion of an independent Data Safety Monitoring Board review of Stage 1 safety and tolerability data.
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
- GSK plc GSK
- Sinovac Biotech Ltd SVA
- Valneva SE VALN
- Kamada Ltd KMDA
- CorMedix Inc. CRMD
- Atea Pharmaceuticals, Inc. AVIR
- SIGA Technologies, Inc. SIGA
- Invivyd, Inc. IVVD
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.