{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-242917","form_type":"8-K","ticker":"FLGT","cik":"0001674930","company_name":"Fulgent Genetics, Inc.","filed_at":"2025-10-20T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.117212+00:00","generated_at":"2026-05-17T03:14:52.519436+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"Fulgent reports Phase 2 FID-007 combo data: 51% ORR, PFS 7.8 months in R/M HNSCC","bullets":["Preliminary Phase 2 data for FID-007 + cetuximab in 1L-2L R/M HNSCC; 39 patients randomized.","Overall ORR 51% (75 mg/m2: 44%, 125 mg/m2: 59%); median PFS 7.8 months vs historical 2.3 months.","Treatment-related SAE rate 6%; no grade 3+ peripheral neuropathy; common grade 3+ events include lymphopenia (19%) and neutropenia (17%).","Data presented at ESMO 2025 on October 20; optimal dose to be determined after data maturation.","CEO Ming Hsieh cites steady advancement of FID-007 and strong momentum in precision diagnostics."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-242917","json":"https://secwatch.observer/filing/0001193125-25-242917.json","markdown":"https://secwatch.observer/filing/0001193125-25-242917.md","text":"https://secwatch.observer/filing/0001193125-25-242917.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1674930/000119312525242917/0001193125-25-242917-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1674930/000119312525242917/flgt-20251020.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T03:14:52.519436+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"}