{"schema_version":"secwatch.filing_event.v1","accession":"0001937653-26-000051","form_type":"8-K","ticker":"ZYME","cik":"0001937653","company_name":"Zymeworks Inc.","filed_at":"2026-08-25T14:54:11+00:00","discovered_at":"2026-08-25T14:55:00.386977+00:00","generated_at":"2026-08-25T14:55:09.329473+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"FDA approves zanidatamab combo for HER2+ GEA; Zymeworks earns $250M milestone","bullets":["FDA approval of Ziihera (zanidatamab-hrii) with/without tislelizumab plus chemo in first-line HER2+ GEA triggers $250M milestone from Jazz.","Zymeworks has now received $650M total upfront and milestone payments from Jazz; remains eligible for up to $1.3B more and 10-20% royalties.","BeOne collaboration: $81M received to date; up to $144M additional milestones plus up to 19.5% royalties on sales.","Approval based on Phase 3 HERIZON-GEA-01 trial (published in NEJM); second FDA approval for zanidatamab in under two years."],"urls":{"canonical":"https://secwatch.observer/filing/0001937653-26-000051","json":"https://secwatch.observer/filing/0001937653-26-000051.json","markdown":"https://secwatch.observer/filing/0001937653-26-000051.md","text":"https://secwatch.observer/filing/0001937653-26-000051.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1937653/000193765326000051/0001937653-26-000051-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1937653/000193765326000051/zyme-20260825.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-08-25T14:55:09.329473+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"}