NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) announced on September 28, 2026, that it has scheduled an in-person meeting with the U.S. Food and Drug Administration (FDA) for November 17, 2026. The meeting is set to take place at the FDA’s White Oak campus in Silver Spring, Maryland. The session is an End-of-Phase 1 Type B meeting regarding the company’s investigational drug, NEO212.
The meeting will focus on the NEO212 clinical development program. NeOnc plans to seek FDA feedback on several key areas, including an update to the proposed patient population, trial design, endpoints, dose selection, and the evidence required to support a future marketing application.
NEO212 is an investigational oral conjugate of temozolomide and NEO100 currently being studied for central nervous system (CNS) cancers. The company noted that the meeting provides an opportunity for discussion and does not establish FDA agreement on a trial design, an accelerated approval pathway, or eventual approval of the drug.
This meeting follows the completion of the Phase 1 dose-escalation portion of the NEO212-01 trial. Dose escalation was discontinued following a dose-limiting toxicity at 810 mg, administered once daily on Days 1 through 5 of a 28-day cycle. Consequently, 610 mg was selected as the recommended Phase 2 dose. During the Phase 1 portion, the company reported encouraging clinical activity. In one patient with recurrent IDH1 wild-type, MGMT-methylated glioblastoma, treatment resulted in a partial response with an approximately 60% reduction in tumor size and 21 months of disease control. In a second patient with lung cancer metastatic to the brain who had progressed following multiple lines of therapy, treatment was associated with stable disease lasting approximately 16 months.
NeOnc intends to discuss its potential registrational development strategy and to seek FDA feedback on whether a proposed trial design could support a potential accelerated approval pathway.
