NeOnc Technologies Receives FDA Authorization to Proceed with Phase II Clinical Trial of NEO212 – A First-in-Class Oral Chemical Conjugated Chemotherapy Candidate for Brain Cancer
NeOnc Technologies Holdings, Inc. (NTHI)
Company Research
Source: GlobeNewswire
CALABASAS, Calif., Sept. 10, 2025 (GLOBE NEWSWIRE) -- NeOnc Technologies Holdings, Inc. (NASDAQ: NTHI) (“NeOnc” or the “Company”), a multi-Phase 2 clinical-stage biopharmaceutical company pioneering therapies for central nervous system (CNS) cancers, today announced that the U.S. Food and Drug Administration (FDA) has authorized the Company to proceed with Phase IIa/IIb of its NEO212-01 clinical trial. The FDA’s decision follows the successful completion of the Phase I dose-escalation study, which demonstrated that NEO212 could be safely administered at doses up to 810 mg daily on Days 1–5 of a 28-day cycle. Independent review of the recommended Phase II dose is ongoing, with patient enrollment expected to begin before the end of 2025. A Next-Generation Standard of Care Candidate NEO212 is NeOnc’s first oral chemical conjugated chemotherapy drug, uniquely combining Temozolomide (TMZ) – the current standard of care for glioblastoma and other brain cancers (marketed as Temodar®) –
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NTHI
News
- NeOnc Technologies (Nasdaq: NTHI) Announces AI-Driven Findings Showing Ultrasound Enhances the Potency of an Already Effective NEO100 in Treating Primary and Metastatic Brain Tumors [Yahoo! Finance]Yahoo! Finance
- NeOnc Technologies (Nasdaq: NTHI) Announces AI-Driven Findings Showing Ultrasound Enhances the Potency of an Already Effective NEO100 in Treating Primary and Metastatic Brain TumorsGlobeNewswire
- With 61% ownership, NeOnc Technologies Holdings, Inc. (NASDAQ:NTHI) insiders have a lot riding on the company's future [Yahoo! Finance]Yahoo! Finance
- NeOnc Technologies Holdings GAAP EPS of -$0.45 [Seeking Alpha]Seeking Alpha
- NeOnc Technologies Holdings Reports Third Quarter 2025 Results and Provides Operational UpdateGlobeNewswire
NTHI
Sec Filings
- 11/24/25 - Form 4
- 11/24/25 - Form 3
- 11/24/25 - Form 4
- NTHI's page on the SEC website