NeOnc Receives FDA Written Feedback on NEO212 CMC Development and Capsule-to-Tablet Transition

2026-07-15 09:00:00

CALABASAS, Calif., July 15, 2026 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (NASDAQ: NTHI) (“NeOnc” or the “Company”), a clinical-stage life sciences company focused on the development of treatments for central nervous system cancers, today announced that it has received written feedback from the U.S. Food and Drug Administration (“FDA”) regarding the chemistry, manufacturing and controls (“CMC”) development program for NEO212, the Company's novel temozolomide-perillyl alcohol conjugate.

Wall Street is Watching These Biotechs

2026-07-01 09:32:00

Three emerging biotechnology companies, Can-Fite (NYSE: CANF), NeOnc (NASDAQ: NTHI), and PMGC (NASDAQ: ELAB) are pursuing a distinct therapeutic strategy

NeOnc Ignites Explosive Summer: 4 New Research Reports + UAE/Dubai Drug Approval Fuel Breakout Momentum

2026-06-24 08:45:00

DENVER, June 24, 2026 (GLOBE NEWSWIRE) -- ( 247marketnews.com ) -- NeOnc Technologies Holdings (NASDAQ: NTHI) is entering one of the most significant periods in its corporate history after securing its second Investigational New Drug (IND) authorization from the United Arab Emirates this month, further expanding international development opportunities for its central nervous system cancer pipeline. The latest authorization from the Department of Health – Abu Dhabi grants IND status to NEO100, NeOnc's lead intranasal therapy candidate for recurrent high-grade gliomas.

NeOnc Technologies Receives UAE IND Approval for NEO100, Expanding Global Development Ahead of Anticipated Phase 2 Data Milestone

2026-06-23 09:00:00

Authorization covers all three NEO100 programs across adult Phase 1 through Phase 2, plus pediatric studies Extends NeOnc's UAE footprint beyond NEO212 and complements ongoing U.S. development, where NEO100 holds FDA Orphan Drug, Fast Track, and Rare Pediatric Disease designations CALABASAS, Calif., June 23, 2026 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) (“NeOnc” or the “Company”), a clinical-stage biopharmaceutical company developing novel therapies for central nervous system (CNS) cancers, today announced that the Department of Health – Abu Dhabi (DOH) has granted Investigational New Drug (IND) status for NEO100, the Company's lead candidate, an intranasally administered formulation of purified perillyl alcohol designed for non-invasive nose-to-brain delivery.

WSTPR Catalyst Watch: Abu Dhabi Regulatory Clearance Adds Momentum to NeOnc's Global Neuro-Oncology Strategy

2026-06-22 08:45:00

International Regulatory Validation Has Preceded Several Recent FDA Success Stories, Though Significant Development Risks Remain Houston, Texas--(Newsfile Corp. - June 22, 2026) - NeOnc Technologies Holdings (NASDAQ: NTHI) recently achieved what many biotechnology companies spend years attempting to secure: international regulatory validation for a novel therapeutic candidate before obtaining later-stage U.S. approvals. The Department of Health - Abu Dhabi's Investigational New Drug (IND) authorization for NEO212 marks the first international regulatory clearance for the company's oral perillyl alcohol-temozolomide conjugate, opening an additional clinical development pathway for a therapy designed to treat aggressive brain cancers, including glioblastoma.

NeOnc's Global Expansion Accelerates After Abu Dhabi IND Approval for NEO212

2026-06-17 09:18:00

DALLAS, June 17, 2026 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings (NASDAQ: NTHI) is rapidly emerging as a development-stage neuro-oncology innovator, as it advances a growing pipeline of therapies designed to address some of the most difficult cancers to treat. Its critical data efforts received a significant boost after the company announced that the Department of Health – Abu Dhabi granted Investigational New Drug (IND) authorization for NEO212, NeOnc's oral perillyl alcohol-temozolomide conjugate being developed for aggressive brain tumors, including glioblastoma.

Brain Cancer Innovator NeOnc Heads into Critical Data Season with Fresh Abu Dhabi IND

2026-06-16 13:49:00

DENVER, June 16, 2026 (GLOBE NEWSWIRE) -- ( 247marketnews.com ) – NeOnc Technologies Holdings (NASDAQ: NTHI) continues to build momentum as a neuro-oncology sector trailblazer, as it advances multiple clinical programs targeting some of the most difficult cancers to treat, after announcing that the Department of Health – Abu Dhabi granted Investigational New Drug (IND) authorization for NEO212, the company's oral perillyl alcohol-temozolomide conjugate being developed for aggressive brain tumors. The approval represents the first international regulatory clearance for NEO212 following completion of the Phase 1 dose-escalation study, which established 610 mg as the recommended Phase 2 dose.

NeOnc Technologies Secures UAE IND Approval for NEO212 Following Successful Phase 1 Completion, Advancing Toward Global Phase 2 Development

2026-06-16 09:00:00

Clearance enables Phase 2 evaluation of NEO212, the Company's oral perillyl alcohol-temozolomide conjugate, in the United Arab Emirates Follows completion of Phase 1 dose escalation and selection of 610 mg as the recommended Phase 2 dose Adds an international clinical pathway alongside continuing U.S. FDA discussions on a potential registrational pathway for NEO212 CALABASAS, Calif., June 16, 2026 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (Nasdaq: NTHI) (“NeOnc” or the “Company”), a clinical-stage biopharmaceutical company developing novel therapies for central nervous system (CNS) cancers, today announced that the Department of Health – Abu Dhabi (DOH) has granted Investigational New Drug (IND) status for NEO212, the Company's orally administered perillyl alcohol-temozolomide carbamate conjugate being developed for patients with aggressive brain tumors.