RegulatoryCompany release

FDA grants NeOnc Type B meeting on accelerated approval path for intranasal NEO100

🇺🇸 Neonc Technologies Holdings, Inc. (NTHI) · Fri 13 Nov 2026

NeOnc will use the early January 2027 meeting to test whether Phase 2a data can back a 505(b)(2) application for NEO100 in recurrent IDH-mutant grade 4 astrocytoma.

NeOnc Technologies Holdings announced on 11 November 2026 that the US Food and Drug Administration has granted a Type B End-of-Phase meeting on its intranasal product NEO100. The meeting is scheduled for early January 2027.

The product is being developed for recurrent or progressive IDH-mutant grade 4 astrocytoma. NeOnc says it will ask the agency whether its Phase 2a data could support a 505(b)(2) new drug application under the accelerated approval pathway.

The company also intends to seek agreement on the design of a Phase 3 study, NEO100-012, which has overall survival as its primary endpoint. Under the company's plan, this trial would act as the confirmatory study for any accelerated approval.

NeOnc stresses that holding the meeting does not mean the FDA has agreed to any regulatory pathway. The company says it will provide an update once it receives the agency's official minutes.

As general context, a Type B meeting is a formal sponsor-FDA discussion at key development milestones, and a 505(b)(2) application is a route that can rely in part on data not generated by the applicant.

What it means for your team

  • The meeting outcome, not its grant, will show whether the FDA is receptive to an accelerated approval filing based on Phase 2a data.
  • Agreement on the Phase 3 NEO100-012 design, including the overall survival endpoint, would clarify the confirmatory evidence expected.
  • Teams tracking neuro-oncology filings should watch for NeOnc's update after the official FDA minutes arrive.

Company's press release (SEC filing): Neonc Technologies Holdings, Inc. ↗

Article written by VigiEye from the official source (Neonc Technologies Holdings, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

More Regulatory All →