secwatch.observer — SEC 8-K summary
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Issuer:     NEONC TECHNOLOGIES HOLDINGS, INC. (NTHI)
CIK:        0001979414
Form:       8-K
Filed at:   2026-03-06T23:59:59+00:00
Accession:  0001829126-26-002020
Event type: other_material
Sentiment:  positive
Materiality: 0.85
Item codes: 7.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

NeOnc reports Phase 1 dose-escalation results for NEO212; RP2D set at 610 mg
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- MTD reached at 810 mg (Cohort 5) with second DLT; dose escalation halted.
- Recommended Phase 2 Dose (RP2D) set at 610 mg; Phase 2a metastasis start at 400 mg.
- Early efficacy signals: partial response in recurrent GBM (~60% tumor reduction after 21 cycles) and stable disease in brain metastasis.
- No clinically meaningful myelosuppression; 39x lower AIC vs TMZ indicating lower toxicity.
- Type B FDA meeting to be requested for accelerated approval pathway.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1979414/000182912626002020/0001829126-26-002020-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1979414/000182912626002020/neonctechnologies_8k.htm
  HTML page:      https://secwatch.observer/filing/0001829126-26-002020

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer