{"schema_version":"secwatch.filing_event.v1","accession":"0001125345-26-000009","form_type":"8-K","ticker":"MGNX","cik":"0001125345","company_name":"MACROGENICS INC","filed_at":"2026-02-24T23:59:59+00:00","discovered_at":"2026-05-14T18:02:34.569578+00:00","generated_at":"2026-05-16T00:39:10.289740+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"FDA partial clinical hold on MacroGenics' Phase 2 LINNET study of lorigerlimab after severe safety events","bullets":["Partial hold halts new enrollment; current participants may continue receiving lorigerlimab.","Safety events across 4 patients: Grade 4 thrombocytopenia (2), myocarditis (1), neutropenia with septic shock (1) leading to 1 death (Grade 5).","41 patients dosed at 6 mg/kg every 3 weeks in platinum-resistant ovarian and clear cell gynecologic cancer cohorts.","MacroGenics commits to working with FDA to resolve the hold and resume enrollment."],"urls":{"canonical":"https://secwatch.observer/filing/0001125345-26-000009","json":"https://secwatch.observer/filing/0001125345-26-000009.json","markdown":"https://secwatch.observer/filing/0001125345-26-000009.md","text":"https://secwatch.observer/filing/0001125345-26-000009.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1125345/000112534526000009/0001125345-26-000009-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1125345/000112534526000009/mgnx-20260223.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T00:39:10.289740+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"}