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Decision-gradePagbabago sa trial registry

Vaxcyte ay sumusulong sa VAX-31 adult Phase 3 program; OPUS-1 topline Q4 2026

Vaxcyte ay nagtapos ng komprehensibong VAX-31 adult Phase 3 program na may pagkakahanay sa FDA at nagpasimula ng tatlong Phase 3 trials (OPUS-1, OPUS-2, OPUS-3) upang suportahan ang planadong BLA submission. Topline safety, tolerability at immunogenicity data mula sa pivotal OPUS-1 noninferiority trial ay inaasahan sa Q4 2026, kasama ang OPUS-2 at OPUS-3 data sa H1 2027. Nakumpleto rin ang enrollment sa VAX-31 infant Phase 2 dose-finding study, na may topline data na inaasahan sa pagtatapos ng H1 2027.

Mahahalagang fact

Na-file
Peb 24, 2026, 09:14 PM
Kaganapan
Pagbabago sa trial registry
Direksyon
Positibo
Kumpanya
PCVXVaxcyte
Asset
VAX-31
Pinagmulan
SEC 8-K
Kumpiyansa
May source

Sipi mula sa source

EX-99.1 2 pcvx-20260224xexx991.htm EX-99.1 Document Exhibit 99.1 Vaxcyte Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Business Update Comprehensive VAX-31 Adult Phase 3 Clinical Program, Finalized in Consultation and Alignment with FDA, Advances with Three Phase 3 Studies Underway to Support Planned BLA Submission Topline Safety, Tolerability and Immunogenicity Data from OPUS-1 Expected in Fourth Quarter of 2026; OPUS-2 and OPUS-3 Results Expected in First Half of 2027 Enrollment Completed in VAX-31 Infant Phase 2 Dose-Finding Study; Topline Safety, Tolerability and Immunogenicity Data from Primary Immunization Series and Booster Dose Expected Either Sequentially or Together by End of First Half of 2027 Company Advancing Early-Stage Pipeline, Expects to I

SEC 8-K

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