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Get filing alertsVaxcyte narrows VAX-31 OPUS-1 topline data guidance to end of October 2026
Filed September 3, 2026 · Period ending August 31, 2026 · ~1 min read
Key Changes
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Topline safety, tolerability and immunogenicity data from the VAX-31 adult Phase 3 OPUS-1 trial are now expected by the end of October 2026, narrowed from prior fourth-quarter guidance.
Item 7.01 verify on EDGAR → -
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The VAX-31 adult Phase 3 program is fully enrolled across three trials with 6,191 adults dosed, approximately 3,500 of whom received VAX-31.
Exhibit 99.1 view on EDGAR → -
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Vaxcyte appointed Luis Jodar, Ph.D. as Chief Medical Officer; he previously led vaccines and infectious diseases at Pfizer with nearly 20 years of pneumococcal conjugate vaccine experience.
Exhibit 99.1 view on EDGAR → -
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Vaxcyte appointed David McAvoy, J.D. as Chief Legal Officer, Chief Compliance Officer, and Corporate Secretary; he joins from Teva where he was EVP and Chief Legal Officer.
Item 5.02 verify on EDGAR → -
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Safety, tolerability and immunogenicity data from the OPUS-2 and OPUS-3 Phase 3 trials are expected in the first half of 2027.
Exhibit 99.1 view on EDGAR →
Summary
Vaxcyte narrowed the expected timing for topline data from its VAX-31 adult Phase 3 OPUS-1 trial to the end of October 2026, versus the previously communicated fourth quarter of 2026. This is a key near-term catalyst for the company's lead vaccine candidate.
The company also disclosed that the full VAX-31 adult Phase 3 program is fully enrolled across three trials with 6,191 adults dosed, approximately 3,500 of whom received VAX-31. Data from the OPUS-2 and OPUS-3 trials are expected in the first half of 2027.
In conjunction, Vaxcyte announced two executive appointments: Luis Jodar, Ph.D. as Chief Medical Officer and David McAvoy, J.D. as Chief Legal Officer, Chief Compliance Officer, and Corporate Secretary. Jodar brings nearly 20 years of pneumococcal conjugate vaccine experience from Pfizer, while McAvoy joins from Teva with over three decades of biopharmaceutical legal leadership. Mikhail Eydelman continues as Senior Vice President, General Counsel. For retail holders, the narrowed OPUS-1 data timing provides a more precise near-term catalyst, and the executive additions strengthen leadership ahead of the planned BLA submission. The filing contains no red flags.
Section-by-Section Diff
Event · Item 5.02 — Departure of Directors or Certain Officers; Election of Directors; Compensation
Item 5.02 — Departure of Directors or Certain Officers; Election of Directors; Compensation filed; see Key Changes for terms.
Added in current filing · verify on EDGAR →
On August 31, 2026, Vaxcyte, Inc. (the “Company”) appointed David McAvoy as the Company's Chief Legal Officer, Chief Compliance Officer, and Corporate Secretary. Mikhail Eydelman continues to serve as Senior Vice President, General Counsel.
The company named David McAvoy to three senior legal and compliance roles effective August 31, 2026. Mikhail Eydelman remains with the company as Senior Vice President, General Counsel, so this is an addition rather than a departure.
Event · Item 7.01 — Regulation FD Disclosure
Vaxcyte appoints a Chief Medical Officer and Chief Legal Officer and narrows guidance for VAX-31 OPUS-1 topline data.
Added in current filing · verify on EDGAR →
Vaxcyte Appoints Chief Medical Officer and Chief Legal Officer; Narrows Guidance for Expected VAX-31 OPUS-1 Topline Data.
The company announced the appointment of a new Chief Medical Officer and a new Chief Legal Officer. The 8-K itself does not name the individuals or provide their backgrounds; those details are in the furnished press release (Exhibit 99.1).
Added in current filing · verify on EDGAR →
Narrows Guidance for Expected VAX-31 OPUS-1 Topline Data.
Vaxcyte narrowed the expected timing guidance for topline data from its VAX-31 OPUS-1 clinical trial. The 8-K does not state the new window; the specific narrowed guidance is in the press release furnished as Exhibit 99.1.
Event · Exhibit 99.1
Added in current filing · view on EDGAR →
today announced the appointments of experienced industry leaders Luis Jodar, Ph.D. as Chief Medical Officer and David McAvoy, J.D. as Chief Legal Officer.
Vaxcyte appointed Luis Jodar, Ph.D. as Chief Medical Officer. He previously served as Senior Vice President and Chief Medical Officer for Vaccines and Infectious Diseases at Pfizer, with nearly 20 years of experience in pneumococcal conjugate vaccines including Prevnar 13 and Prevnar 20. This leadership addition comes as the company approaches the OPUS-1 topline readout and planned BLA submission.
Added in current filing · view on EDGAR →
today announced the appointments of experienced industry leaders Luis Jodar, Ph.D. as Chief Medical Officer and David McAvoy, J.D. as Chief Legal Officer.
Vaxcyte appointed David McAvoy, J.D. as Chief Legal Officer. He joins from Teva Pharmaceutical Industries Ltd., where he served as Executive Vice President and Chief Legal Officer leading a 235-person legal, compliance and government affairs organization. He brings over three decades of biopharmaceutical legal leadership experience.
Added in current filing · view on EDGAR →
topline safety, tolerability and immunogenicity data from the VAX-31 adult Phase 3 OPUS-1 trial are now expected by the end of October, narrowing its previously communicated guidance of disclosing topline trial data in the fourth quarter of this year.
The company narrowed its guidance for the VAX-31 adult Phase 3 OPUS-1 pivotal trial topline data readout to the end of October 2026, versus the previously communicated fourth quarter of 2026. This is a key near-term catalyst for the company's lead vaccine candidate.
Added in current filing · view on EDGAR →
Announce safety, tolerability and immunogenicity data from the OPUS-2 and OPUS-3 Phase 3 trials in the first half of 2027.
Vaxcyte provided guidance that safety, tolerability and immunogenicity data from the OPUS-2 and OPUS-3 Phase 3 trials are expected in the first half of 2027. This extends the clinical data readout timeline beyond the OPUS-1 topline expected by end of October 2026.
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Figures/quotes linked to EDGAR · Narrative written by AI · Sep 4, 2026 · How we verify