NeOnc secures FDA meeting on potential accelerated approval for NEO100 brain cancer therapy
NTHI•NeOnc Technologies secured an FDA meeting in early January 2027 to discuss potential accelerated approval for intranasal NEO100. A proposed Phase 3 trial would compare it with chemotherapy in recurrent or progressive IDH-mutant grade 4 astrocytoma.
1. FDA meeting planned
NeOnc Technologies secured an FDA meeting in early January 2027 to discuss potential accelerated approval for intranasal NEO100. The proposed Phase 3 trial would compare the therapy with chemotherapy in recurrent or progressive IDH-mutant grade 4 astrocytoma.
2. Earlier trial results
Phase 2a results reported on August 12, 2026, showed progression-free survival exceeded the trial’s standard-of-care benchmark. No serious treatment-related adverse events were reported; side effects were mild to moderate and predominantly affected the nose or upper airway. Enrollment in the confirmatory trial is expected to be ongoing at any application submission, with survival results intended to support conversion to traditional approval.
