{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-263398","form_type":"8-K","ticker":"ZYME","cik":"0001937653","company_name":"Zymeworks Inc.","filed_at":"2024-11-21T23:59:59+00:00","discovered_at":"2026-05-14T18:03:10.383241+00:00","generated_at":"2026-05-29T21:19:04.248400+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA grants accelerated approval to Zymeworks' Ziihera for HER2+ BTC; $25M milestone earned","bullets":["Ziihera (zanidatamab-hrii) approved for adults with previously-treated unresectable/metastatic HER2+ BTC.","Approval based on 52% objective response rate and median DOR of 14.9 months from HERIZON-BTC-01 trial.","Zymeworks earns $25M milestone from Jazz; eligible for up to $500M regulatory + $862.5M commercial milestones.","Continued approval contingent on Phase 3 HERIZON-BTC-302 confirmatory trial.","Zanidatamab also in Phase 3 trials for GEA (top-line PFS data Q2 2025) and mBC."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-263398","json":"https://secwatch.observer/filing/0001193125-24-263398.json","markdown":"https://secwatch.observer/filing/0001193125-24-263398.md","text":"https://secwatch.observer/filing/0001193125-24-263398.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1937653/000119312524263398/0001193125-24-263398-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1937653/000119312524263398/d769907d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-29T21:19:04.248400+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"}