---
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"
generated_at: "2026-10-12T13:37:30.627892+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.5
calibrated_materiality_score: 0.5
confidence: "high"
source: SEC EDGAR
---

# NeOnc sets Nov 17 FDA End-of-Phase 1 Type B meeting for NEO212; RP2D 610 mg after DLT at 810 mg

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.5
- calibrated_materiality_score: 0.5
- confidence: high
- sec_items: 7.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001829126-26-010493
- JSON: https://secwatch.observer/filing/0001829126-26-010493.json
- Plain text: https://secwatch.observer/filing/0001829126-26-010493.txt

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