NeOnc Technologies Holdings, Inc., a clinical-stage biopharmaceutical company, focuses on developing treatments for intracranial malignancies. Its lead product candidates include NEO100, a purified form of preillyl acid …
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NeOnc Receives FDA Written Feedback on NEO212 CMC Development and Capsule-to-Tablet Transition 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. The written feedback was provided in advance of a Type B End-of-Phase 1 meeting scheduled for July 9, 2026. FDA's preliminary comments expressly provided NeOnc the option to cancel the meeting if the written responses were sufficiently clear, in which case the written responses would constitute the official record of the meeting. | ||
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