NeOnc Technologies Granted FDA Type B End-of-Phase Meeting to Discuss Potential Accelerated Approval Pathway and Phase 3 Confirmatory Trial for Intranasal NEO100

CALABASAS, Calif., Nov. 11, 2026 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) (“NeOnc” or the “Company”), a clinical-stage biopharmaceutical company developing therapies for central nervous system (CNS) cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted the Company a Type B End-of-Phase meeting to discuss a potential accelerated approval pathway for intranasal NEO100 in recurrent or progressive IDH-mutant grade 4 astrocytoma. The meeting is scheduled for early January 2027.

At the meeting, NeOnc intends to review the NEO100 nonclinical and clinical data package, including results from the completed Phase 2a portion of the NEO100-01 trial, and to seek the FDA’s feedback on whether these data could support a 505(b)(2) New Drug Application (NDA) seeking accelerated approval under section 506(c) of the Federal Food, Drug, and Cosmetic Act. The Company also intends to seek the FDA’s agreement on the design of NEO100-012, a multicenter, randomized, controlled Phase 3 trial comparing intranasal NEO100 with investigator’s-choice standard-of-care chemotherapy in patients with recurrent or progressive IDH-mutant grade 4 astrocytoma, with overall survival as the primary endpoint. The Phase 3 is intended to serve as the registrational and confirmatory trial for NEO100: under the accelerated approval framework, the Company would expect the trial to be underway, with enrollment ongoing, at the time of any NDA submission, and its final overall survival analysis to verify clinical benefit and support conversion to traditional approval. Discussion topics will also include the adequacy of the existing nonclinical safety package, the scientific bridge from published perillyl alcohol data to intranasal NEO100, and the eligibility of NEO100 for Breakthrough Therapy designation.