NeOnc Technologies notifies availability of announcement on FDA feedback for NEO212 development

NeOnc Technologies Holdings, Inc.

NeOnc Technologies Holdings, Inc.

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  • NeOnc Technologies Holdings published an update on FDA written feedback covering CMC requirements for continued late-stage development of NEO212.
  • FDA signaled the CMC approach appears reasonable, flagged added comparability work if manufacturing changes.
  • Agency recommended an in vivo relative bioavailability study to support a capsule-to-tablet transition.
  • NeOnc canceled a scheduled July 9, 2026 Type B End-of-Phase 1 meeting, treating the written feedback as the official record.


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