OPUS-1 Phase 3 pivotal topline for VAX-31 in adults
Vaxcyte expects to report results from its Phase 3 study of VAX-31 for Invasive pneumococcal disease/pneumonia prevention, adults in Q4 2026 (Oct–Dec) (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- Vaxcyte, Inc. PCVX
- Drug
- VAX-31
- For
- Invasive pneumococcal disease/pneumonia prevention, adults
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- Q4 2026 · the company gave a window, not a day; the calendar never invents one
- Source note
- Q2 2026 update (Aug 5, 2026): topline safety, tolerability and immunogenicity data from OPUS-1 (4,049 participants) expected in fourth quarter of 2026.
- Checked
- Checked by a person when it was added
- Source: biospace.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- PCVX headlines on this site
Vaxcyte expects to report results from its Phase 3 study of VAX-31 for Invasive pneumococcal disease/pneumonia prevention, adults in the first half of 2027 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.
More details
- Entry
- OPUS-2 and OPUS-3 Phase 3 data for VAX-31 in adults · Clinical trial results (readout / topline data)
- Drug
- VAX-31
- For
- Invasive pneumococcal disease/pneumonia prevention, adults
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- H1 2027 · the company gave a window, not a day
- Source note
- Q2 2026 update: OPUS-2 (flu co-administration) and OPUS-3 (previously vaccinated adults) data expected in first half of 2027; BLA submission planned thereafter.
- Checked
- Checked by a person when it was added
- Verify it
- Source: biospace.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- PCVX headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page