---
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"
generated_at: "2026-05-17T03:14:52.519436+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# Fulgent reports Phase 2 FID-007 combo data: 51% ORR, PFS 7.8 months in R/M HNSCC

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: other_material
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-242917
- JSON: https://secwatch.observer/filing/0001193125-25-242917.json
- Plain text: https://secwatch.observer/filing/0001193125-25-242917.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.