NeOnc receives FDA authorization to proceed with Phase II trial of NEO212

NeOnc Technologies (NTHI) 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.