{"schema_version":"secwatch.filing_event.v1","accession":"0001829126-26-010493","form_type":"8-K","ticker":"NTHI","cik":"0001979414","company_name":"NEONC TECHNOLOGIES HOLDINGS, INC.","filed_at":"2026-09-28T21:00:22+00:00","discovered_at":"2026-09-28T21:02:25.073369+00:00","generated_at":"2026-10-12T13:37:30.627892+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"neutral","materiality_score":0.5,"calibrated_materiality_score":0.5,"confidence":"high","headline":"NeOnc sets Nov 17 FDA End-of-Phase 1 Type B meeting for NEO212; RP2D 610 mg after DLT at 810 mg","bullets":["FDA End-of-Phase 1 Type B meeting scheduled Nov 17, 2026, in person at FDA's White Oak campus in Silver Spring, Md., covering NEO212 patient population, trial design, endpoints and dose selection.","Phase 1 dose escalation completed; discontinued after a dose-limiting toxicity at 810 mg (once daily, Days 1-5 of a 28-day cycle); 610 mg selected as recommended Phase 2 dose.","One patient with recurrent IDH1 wild-type, MGMT-methylated glioblastoma had a partial response with ~60% tumor size reduction and 21 months of disease control.","A second patient with lung cancer metastatic to the brain, previously progressed on multiple lines including checkpoint inhibitors, had stable disease lasting ~16 months.","NeOnc will seek FDA feedback on whether a proposed design could support accelerated approval; FDA authorized the Phase 2a/2b portions of NEO212-01 in September 2025."],"urls":{"canonical":"https://secwatch.observer/filing/0001829126-26-010493","json":"https://secwatch.observer/filing/0001829126-26-010493.json","markdown":"https://secwatch.observer/filing/0001829126-26-010493.md","text":"https://secwatch.observer/filing/0001829126-26-010493.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1979414/000182912626010493/0001829126-26-010493-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1979414/000182912626010493/neonctechnologies_8k.htm"},"model":{"generated_by":"deepseek-v4.1-flash:cloud@v2","generated_at":"2026-10-12T13:37:30.627892+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"}