---
schema_version: "secwatch.filing_event.v1"
accession: "0001829126-26-007585"
form_type: "8-K"
ticker: "NTHI"
cik: "0001979414"
company_name: "NEONC TECHNOLOGIES HOLDINGS, INC."
filed_at: "2026-07-15T13:15:28+00:00"
generated_at: "2026-07-15T13:16:19.605120+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# NeOnc receives FDA written feedback on NEO212 CMC development; cancels Type B meeting

## Summary
- FDA provided detailed CMC feedback for NEO212, a temozolomide-perillyl alcohol conjugate for CNS cancers.
- FDA stated NeOnc's CMC approach appears reasonable; additional comparative assessments may be needed if process changes.
- FDA allowed parallel CMC development with late-stage clinical program, subject to supporting data.
- FDA requires an in vivo relative bioavailability study to support capsule-to-tablet transition.
- NeOnc canceled the July 9 Type B End-of-Phase 1 meeting after determining written responses were sufficiently clear.

## SEC filing metadata
- accession: 0001829126-26-007585
- form_type: 8-K
- ticker: NTHI
- cik: 0001979414
- company_name: NEONC TECHNOLOGIES HOLDINGS, INC.
- filed_at: 2026-07-15T13:15:28+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 7.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1979414/000182912626007585/0001829126-26-007585-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1979414/000182912626007585/neonctechnologies_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001829126-26-007585
- JSON: https://secwatch.observer/filing/0001829126-26-007585.json
- Plain text: https://secwatch.observer/filing/0001829126-26-007585.txt

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