secwatch / observer

8-K filed May 21, 2026, 5:04 PM ET ticker FLGT CIK 0001674930

other material confidence high sentiment positive materiality 0.60

Fulgent reports FID-007 + cetuximab Phase 2 HNSCC data: 60% ORR, 7.2 mo mPFS

Fulgent Genetics, Inc.

Interim Phase 2 data: ORR 60% (58% Arm A, 61% Arm B); mPFS 7.2 months across 42 evaluable patients.
Median DoR 7.4 months; 56% of responders still responding at Dec 20, 2025 cut-off; OS immature.
Favorable safety: mostly Grade 1-2 TRAEs; Grade 3-4 neutropenia, anemia, leukopenia; one Grade 5 pneumonia (Arm B).
Abstract #6020 presented at ASCO 2026 Rapid Oral Session on June 1, 2026 in Chicago.
Company notes historical standard-of-care offers ORR 5.8%-19.1% and PFS 2.3-3.7 months in R/M HNSCC.

item 8.01 item 9.01

Machine-readable event card

schema_version: secwatch.filing_event.v1
accession: 0001674930-26-000025
form_type: 8-K
ticker: FLGT
cik: 0001674930
company_name: Fulgent Genetics, Inc.
filed_at: 2026-05-21T21:04:12+00:00
discovered_at: 2026-05-21T21:06:00.213115+00:00
generated_at: 2026-05-21T21:10:00.373936+00:00
sec_items: ["8.01", "9.01"]
event_type: other_material
sentiment: positive
materiality_score: 0.6
calibrated_materiality_score: 0.6
confidence: high
secwatch_canonical_url: https://secwatch.observer/filing/0001674930-26-000025
json_url: https://secwatch.observer/filing/0001674930-26-000025.json
markdown_url: https://secwatch.observer/filing/0001674930-26-000025.md
text_url: https://secwatch.observer/filing/0001674930-26-000025.txt
edgar_index_url: https://www.sec.gov/Archives/edgar/data/1674930/000167493026000025/0001674930-26-000025-index.htm
edgar_primary_document_url: https://www.sec.gov/Archives/edgar/data/1674930/000167493026000025/flgt-20260521.htm
generated_by_model: deepseek-v4-flash:cloud@v2
review_status: machine_generated
human_reviewed: false
corrected: false
correction_note: null
correction_timestamp: null
superseded_by: null

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