{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-26-413168","form_type":"8-K","ticker":"PCVX","cik":"0001649094","company_name":"Vaxcyte, Inc.","filed_at":"2026-10-05T12:01:08+00:00","discovered_at":"2026-10-05T12:05:00.290216+00:00","generated_at":"2026-10-12T14:44:50.010891+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Vaxcyte's VAX-31 hits all primary Phase 3 OPUS-1 endpoints in adults, setting up 2028 BLA","bullets":["VAX-31 met noninferiority (LBCI >0.667) for all 28 serotypes shared with PCV20/PCV21 in adults 50+; three VAX-31-unique serotypes plus cross-reactive 20B met superiority (LBCI >2.0).","In adults 18-49 vs 50-64, VAX-31 met noninferiority for all 32 serotype OPA GMR comparisons; well tolerated with safety profile similar to PCV20 and PCV21 across all ages.","Individual comparators: 20 of 20 serotypes vs PCV20 and 17 of 19 vs PCV21 met LBCI >0.667; serotypes 3 and 12F missed that bar but cleared the historical LBCI >0.5 threshold.","OPUS-2 and OPUS-3 Phase 3 results expected 1H 2027, supporting planned BLA submission in 1H 2028; management cites potential 13-36% incremental IPD coverage vs current adult PCVs.","CEO Grant Pickering says OPUS-1 validates the carrier-sparing platform; CMO Luis Jodar notes VAX-31 designed to combine coverage of circulating and historically important serotypes."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-26-413168","json":"https://secwatch.observer/filing/0001193125-26-413168.json","markdown":"https://secwatch.observer/filing/0001193125-26-413168.md","text":"https://secwatch.observer/filing/0001193125-26-413168.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1649094/000119312526413168/0001193125-26-413168-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1649094/000119312526413168/d21202d8k.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-12T14:44:50.010891+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}