Neonc Technologies Holdings, Inc. NTHI
Neonc Technologies Holdings, Inc. (Nasdaq: NTHI) is an oncology drug developer. Its lead program, NEO100 (intranasal perillyl alcohol), is in Phase 2 for recurrent malignant glioma (IDH1-mutant Grade III/IV astrocytoma); also skull-base meningioma. Its next catalyst on record is NEO212: FDA End-of-Phase 1 Type B meeting for NEO212 scheduled for November 17, 2026 to discuss Phase 2 design and possible accelerated approval path. (November 17, 2026).
Upcoming catalysts
- November 17, 2026NEO212 — FDA End-of-Phase 1 Type B meeting for NEO212 scheduled for November 17, 2026 to discuss Phase 2 design and possible accelerated approval path.
today announced that it is scheduled to meet with the U.S. Food and Drug Administration (FDA) on November 17, 2026, for an in-person End-of-Phase 1 Type B meeting concerning NEO212.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| NEO100 (NEO100-01) | recurrent IDH1-mutant malignant glioma | small molecule | Phase 2 |
| NEO100 (NEO100-02) | malignant skull-base meningioma | small molecule | Phase 2 |
| NEO100 pediatric (NEO100-03) | pediatric indication | small molecule | Phase 1 |
| NEO212 | recurrent IDH1 wildtype glioblastoma (planned Phase 2; Phase 1 complete) | small molecule | Phase 1 |
| NEO100 + levodopa | Parkinson's disease | small molecule | Pre-clinical |
| NEO216 | brain cancer (preclinical/early) | small molecule | Pre-clinical |
Recent results and decisions
- Oct 22, 2026started Two children in Abu Dhabi are receiving investigational NEO100 through NeOnc's Compassionate Care program, with a third expected this week.
Two children in Abu Dhabi are currently receiving investigational NEO100 through NeOnc's Compassionate Care program. A third child is expected to be onboarded from India this week.
Filing - Oct 21, 2026n/a NeOnc signed a non-binding MoU with the Department of Health – Abu Dhabi to cooperate on CNS oncology research, clinical capability development, and potential establishment of a regional presence.
Under the MoU, the parties will exchange scientific and clinical knowledge and expertise in CNS oncology and in the development and translation of therapeutics for rare, pediatric and high-unmet-need conditions.
Filing - Aug 12, 2026met Phase 2a met primary endpoint: PFS-6 48.9% (95% CI 26.3-68.1) vs 20% benchmark, p=0.0047, single-arm n=24; median OS 26.09 months, ORR 8.3%.
Six-month progression-free survival (PFS-6) was 48.9% (95% CI: 26.3-68.1) by RANO 2.0 criteria using Kaplan-Meier estimation, compared with the 20% rate pre-specified in the study design as the expectation for standard of care (p = 0.0047).
Filing
4 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 2 oncology companies
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- Tyra Biosciences, Inc. TYRA
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- Obsidian Therapeutics, Inc. OBX
- Puma Biotechnology, Inc. PBYI
- Fulgent Genetics, Inc. FLGT
- Delcath Systems, Inc. DCTH
- Unknown Unknown
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.