secwatch.observer — SEC 8-K summary
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Issuer:     NEONC TECHNOLOGIES HOLDINGS, INC. (NTHI)
CIK:        0001979414
Form:       8-K
Filed at:   2026-09-28T21:00:22+00:00
Accession:  0001829126-26-010493
Event type: regulatory
Sentiment:  neutral
Materiality: 0.50
Item codes: 7.01, 9.01
LLM model:  deepseek-v4.1-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1979414/000182912626010493/0001829126-26-010493-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1979414/000182912626010493/neonctechnologies_8k.htm
  HTML page:      https://secwatch.observer/filing/0001829126-26-010493

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