NeOnc books January FDA talks on filing strategy for nasal brain-cancer drug NEO100

NeOnc Technologies Holdings has secured a formal meeting with the US Food and Drug Administration that could shape how quickly its lead intranasal candidate, NEO100, reaches a marketing application. The company said on 11 November 2026 that the agency had granted an end-of-phase Type B meeting, scheduled for early January 2027.

NEO100 is being developed for patients whose IDH-mutant grade 4 astrocytoma has returned or progressed. NeOnc plans to ask whether results from its Phase 2a study could underpin a 505(b)(2) new drug application, filed under the FDA's accelerated approval framework. The company has not disclosed any revenue, pricing or market-size estimates alongside the announcement.

The company also wants to settle the design of a Phase 3 trial, NEO100-012, with overall survival as the primary endpoint. In NeOnc's plan, that study would serve as the confirmatory trial for any accelerated clearance, so the discussion covers both the route to a first filing and the evidence expected afterwards.

NeOnc was explicit that getting the meeting is not the same as winning the agency's endorsement of a particular route, and said it would update investors once it has the FDA's official minutes. By way of context, a Type B meeting is a formal exchange between a sponsor and the agency at a major development milestone, while a 505(b)(2) application is a pathway that can lean partly on data the applicant did not generate itself.