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FDA Meeting Could Put NeOnc's NEO100 Experimental Brain Cancer Drug on Faster Track

NTHI
  • NeOnc Technologies Holdings (NASDAQ: NTHI) secured a Type B End-of-Phase meeting with the FDA scheduled for early January 2027 to discuss a potential accelerated approval pathway for its experimental intranasal brain cancer treatment NEO100.
  • The company plans to seek FDA feedback on using its existing clinical & nonclinical evidence to support a 505(b)(2) New Drug Application for recurrent or progressive IDH-mutant grade 4 astrocytoma.
  • NeOnc intends to discuss NEO100-012, a proposed randomized Phase 3 trial comparing NEO100 against standard-of-care chemotherapy where overall survival serves as the primary endpoint.
  • Phase 2a results announced on August 12, 2026, showed a six-month progression-free survival rate of 48.9%, exceeding the 20% historical benchmark with a p-value of 0.0047.
  • No treatment-related Grade 3 or higher adverse events, serious adverse events, or discontinuations were reported in the Phase 2a study involving 24 patients with IDH1-mutant tumors.
  • Executive Chairman & CEO Amir Heshmatpour & Dr. Thomas C. Chen purchased 160,016 shares for approximately $629,000 on November 5, 2026, with Heshmatpour continuing to buy 80,000 more shares in early November using personal funds.
  • Heshmatpour's total 2026 open-market purchases reached 271,000 shares worth approximately $1.11 million, signaling management confidence ahead of regulatory milestones.
  • Short interest data from October 30, 2026, showed approximately 920,631 shares sold short, representing 7.03 days to cover, which exceeds the 5-day threshold and suggests a potential squeeze setup.
  • NeOnc expects to present updated NEO100 Phase 1/2a results & NEO212 Phase 1 data at the Society for Neuro-Oncology annual meeting on November 13, 2026.
  • An FDA End-of-Phase 1 Type B meeting for the oral investigational drug candidate NEO212 is scheduled for November 17, 2026.
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Nasdaq:NTHI, 24/7 Market News and NeOnc Technology, $NTHI, FDA, NDA, cancer, oncology