Biopharma · FDA Approvals · Stock

PCVX Vaxcyte

Vaxcyte Inc is a clinical-stage vaccine company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases. It uses the XpressCF cell-free protein synthesis platform to develop potentially superior and novel conjugate and protein vaccine candidates for adult and pediatric indica…

Assets on file: VAX-31

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Catalyst calendar

Dated catalysts for PCVX, including recently decided ones.

January 2027

Jan 2027

~ Jan 2027

PCVXVaxcyte

VAX-31: Phase 3 trial NCT07284654 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

March 2027

Mar 2027

~ Mar 2027

PCVXVaxcyte

VAX-31: Phase 3 trial NCT07425392 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

Mar 2027

~ Mar 2027

PCVXVaxcyte

VAX-31: Phase 3 trial NCT07365826 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

December 2027

Dec 2027

~ Dec 2027

PCVXVaxcyte

VAX-31: Phase 2 trial NCT06720038 expected to finish collecting primary-endpoint data (topline results usually follow)

Trial primary completionClinicalTrials.govMonth only

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Decision-gradeMaterialNotableMinor

Oct 16, 2026

03:24 PM

PCVXVaxcyte

VAX-31 · NCT07284654 registry update

status: ACTIVE_NOT_RECRUITING → COMPLETED; primary_completion: 2027-01 → 2026-09-17; completion: 2027-01 → 2026-09-17

Trial registry changeClinicalTrials.gov Open record

Sep 3, 2026

08:18 PM

PCVXVaxcyte

Vaxcyte narrows VAX-31 OPUS-1 topline readout to end of October 2026

The company narrowed its prior Q4 2026 guidance to a specific end-of-October 2026 target for topline safety, tolerability and immunogenicity data from the adult Phase 3 OPUS-1 pivotal trial. The announcement also disclosed the appointments of a new Chief Medical Officer and Chief Legal Officer ahead of the planned BLA submission.

Topline resultsSEC 8-K Open record2 updates

Feb 24, 2026

09:14 PM

PCVXVaxcyte

Vaxcyte advances VAX-31 adult Phase 3 program; OPUS-1 topline Q4 2026

Vaxcyte finalized a comprehensive VAX-31 adult Phase 3 program with FDA alignment and initiated three Phase 3 trials (OPUS-1, OPUS-2, OPUS-3) to support a planned BLA submission. Topline safety, tolerability and immunogenicity data from the pivotal OPUS-1 noninferiority trial are expected in Q4 2026, with OPUS-2 and OPUS-3 data in H1 2027. Enrollment was also completed in the VAX-31 infant Phase 2 dose-finding study, with topline data expected by end of H1 2027.

Trial registry changeSEC 8-K Open record