Vaxcyte reports Q2 2026 results, OPUS Phase 3 trials fully enrolled, initiates VAX-A1 Phase 1
OPUS-1 topline data are expected in Q4 2026, with OPUS-2, OPUS-3 and VAX-31 infant data to follow in the first half of 2027, alongside a new VAX-A1 Phase 1 start.
Vaxcyte reported second quarter 2026 results on August 5, 2026, with updates across its pneumococcal conjugate vaccine (PCV) and early-stage pipeline programs.
All three ongoing VAX-31 Phase 3 clinical trials, OPUS-1, OPUS-2 and OPUS-3, are fully enrolled, with 6,191 adults dosed in total, approximately 3,500 of whom received VAX-31.1 The studies were finalized in consultation and alignment with the FDA and are designed to generate a broad and robust safety, tolerability and immunogenicity dataset.1 A manufacturing consistency (lot-to-lot) study is also planned as the final Phase 3 study to support the BLA submission.1
In "OPUS-1," 4,049 participants were dosed in the pivotal, noninferiority trial, comparing VAX-31 against Prevnar 20 and Capvaxive head-to-head in pneumococcal-naive U.S. adults aged 50 and older, with an aim of establishing a best-in-class profile.1 A separate cohort of adults aged 18-49 is also being evaluated for safety and immune response.1 In "OPUS-2," 1,390 participants were dosed to assess VAX-31 given concomitantly with or one month after a seasonal flu vaccine in pneumococcal-naive adults 50 and older.1 In "OPUS-3," 752 participants were dosed to evaluate VAX-31 in adults 50 and older who previously received pneumococcal vaccination, including whether it can expand and boost protection against serotypes in lower-valency vaccines.1
The company said it is on track to deliver OPUS-1 topline data in the fourth quarter of 2026, followed by OPUS-2 and OPUS-3 results in the first half of 2027, which along with the manufacturing consistency study would support a planned BLA submission and potential U.S. launch.1
On the early pipeline, the company dosed the first participant in June 2026 in a Phase 1 first-in-human study of VAX-A1 in healthy adults aged 18 to 40 for prevention of Group A Strep disease,1 with topline data expected in the second half of 2027.1
The board appointed two new directors, Dr. Moncef Slaoui and Dr. John Markels, replacing retiring members Mr. Jacks Lee and Dr. Heath Lukatch.1
Cash, cash equivalents and investments were $2,507.7 million as of June 30, 2026, compared to $2,442.6 million as of December 31, 2025.1
Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.