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NeOnc Technologies Granted FDA Type B End-of-Phase Meeting to Discuss Potential Accelerated Approval Pathway and Phase 3 Confirmatory Trial for Intranasal NEO100

NTHI
  • NeOnc Technologies Holdings, Inc. received FDA Type B End-of-Phase meeting approval to discuss a potential accelerated approval pathway for intranasal NEO100 in recurrent or progressive IDH-mutant grade 4 astrocytoma.
  • The meeting is scheduled for early January 2027 to review NEO100 nonclinical & clinical data from the Phase 2a portion of the NEO100-01 trial.
  • NeOnc intends to seek FDA feedback on submitting a 505(b)(2) New Drug Application under section 506(c) of the Federal Food, Drug, and Cosmetic Act.
  • The company plans to align with the FDA on the design of the Phase 3 NEO100-012 trial, which will compare intranasal NEO100 with investigator's-choice standard-of-care chemotherapy.
  • Overall survival is designated as the primary endpoint for the Phase 3 trial, which is intended to serve as the registrational & confirmatory study for converting accelerated approval to traditional approval.
  • On August 12, 2026, NeOnc reported Phase 2a interim results showing a 48.9% six-month progression-free survival rate, exceeding the 20% benchmark for standard of care.
  • Median overall survival from the Phase 2a interim analysis was 26.1 months, with 86.7% estimated overall survival at six months.
  • No treatment-related Grade 3 or higher adverse events, serious adverse events, or discontinuations were reported in the Phase 2a portion; observed adverse events were Grade 1–2 & primarily local nasal or upper-airway effects.
  • Discussion topics for the upcoming meeting include the adequacy of the nonclinical safety package, the scientific bridge from perillyl alcohol data, & the eligibility for Breakthrough Therapy designation.
  • NEO100 is a highly purified form of perillyl alcohol administered intranasally, holding Fast Track & Orphan Drug designations from the FDA for high-grade glioma treatment.
  • NeOnc expects to provide an update following the receipt & review of the FDA's official meeting minutes.
Company
NeOnc Technologies Holdings, Inc.
Keywords
Nasdaq:NTHI, NeOnc Technologies Holdings, Inc., NeOnc, FDA, Accelerated Approval, Type B Meeting, Phase 3, biotechnology, astrocytoma, cancer, CNS, brain tumors, clinical trial, gliomas, data