NeOnc to Meet FDA on Nov. 17 Over NEO212 Brain Cancer Drug; NTHI Up 0.45%

NeOnc Technologies Holdings Inc. (NTHI) said it will meet the U.S. Food and Drug Administration on Nov. 17, 2026, for an End-of-Phase 1 Type B meeting on NEO212, its investigational oral therapy for central nervous system cancers, including recurrent glioblastoma. The meeting will cover patient population, trial design, endpoints, dose selection and evidence needed for a future marketing application. NeOnc will seek FDA feedback on whether a proposed registrational trial could support accelerated approval. The session follows completion of the Phase 1 dose-escalation portion of the NEO212-01 trial, in which a dose-limiting toxicity at 810 mg led to a recommended Phase 2 dose of 610 mg. The FDA authorized Phase 2a and 2b portions in September 2025. NeOnc reported a partial response in one glioblastoma patient, with roughly 60% tumor reduction and 21 months of disease control, and 16 months of stable disease in a second patient. The company cautioned these individual outcomes do not establish efficacy. NTHI traded between $2.95 and $12.99 over the past year and recently changed hands at $3.32, up 0.45%.