{"schema_version":"secwatch.filing_event.v1","accession":"0001125345-26-000026","form_type":"8-K","ticker":"MGNX","cik":"0001125345","company_name":"MACROGENICS INC","filed_at":"2026-04-08T23:59:59+00:00","discovered_at":"2026-05-14T18:02:31.982009+00:00","generated_at":"2026-05-15T06:52:24.238461+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"FDA removes partial clinical hold on MacroGenics' Phase 2 LINNET study of lorigerlimab","bullets":["FDA lifted partial clinical hold on Phase 2 LINNET study of lorigerlimab (bispecific DART targeting PD-1 and CTLA-4).","Revised protocol includes additional risk-mitigation measures for potential hematologic and cardiac toxicities.","MacroGenics plans to resume enrollment in gynecologic cancers (PROC and CCGC); 41 patients dosed to date.","Existing participants continued receiving study drug during the hold; over 300 dosed across all lorigerlimab studies.","Company remains on track to provide a mid-2026 clinical update on the program."],"urls":{"canonical":"https://secwatch.observer/filing/0001125345-26-000026","json":"https://secwatch.observer/filing/0001125345-26-000026.json","markdown":"https://secwatch.observer/filing/0001125345-26-000026.md","text":"https://secwatch.observer/filing/0001125345-26-000026.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1125345/000112534526000026/0001125345-26-000026-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1125345/000112534526000026/mgnx-20260408.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T06:52:24.238461+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"}