{"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","discovered_at":"2026-07-15T13:16:14.355098+00:00","generated_at":"2026-07-15T13:16:19.605120+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"confidence":"high","headline":"NeOnc receives FDA written feedback on NEO212 CMC development; cancels Type B meeting","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001829126-26-007585","json":"https://secwatch.observer/filing/0001829126-26-007585.json","markdown":"https://secwatch.observer/filing/0001829126-26-007585.md","text":"https://secwatch.observer/filing/0001829126-26-007585.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-07-15T13:16:19.605120+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"}