{"schema_version":"secwatch.filing_event.v1","accession":"0001125345-22-000080","form_type":"8-K","ticker":"MGNX","cik":"0001125345","company_name":"MACROGENICS INC","filed_at":"2022-07-08T23:59:59+00:00","discovered_at":"2026-05-14T18:03:55.039893+00:00","generated_at":"2026-06-24T18:03:16.412469+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"negative","materiality_score":0.7,"calibrated_materiality_score":0.7,"confidence":"high","headline":"MacroGenics closes Phase 2 enoblituzumab study after 7 hemorrhagic fatalities in head and neck cancer","bullets":["Phase 2 study CP-MGA271-06 closed due to 7 fatal hemorrhagic events among 62 SCCHN patients.","6 of 7 deaths assessed as unrelated to study treatment; 1 possibly related; incidence exceeded literature rate of 1–3.6%.","Prior enoblituzumab studies in >340 patients had <1% fatal hemorrhage; nonclinical tox showed no coagulopathy.","Company informed FDA and investigators; no new patients enrolled or treated as of July 7, 2022.","Closure does not affect ongoing MGC018 ADC program; internal review and data analysis continue."],"urls":{"canonical":"https://secwatch.observer/filing/0001125345-22-000080","json":"https://secwatch.observer/filing/0001125345-22-000080.json","markdown":"https://secwatch.observer/filing/0001125345-22-000080.md","text":"https://secwatch.observer/filing/0001125345-22-000080.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1125345/000112534522000080/0001125345-22-000080-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1125345/000112534522000080/mgnx-20220708.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-24T18:03:16.412469+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"}