NeOnc Technologies notifies availability of announcement on FDA feedback for NEO212 development
NTHI•FDA feedback on NEO212 development
NeOnc Technologies Holdings published an update on FDA written feedback covering CMC requirements for continued late-stage development of NEO212.
The FDA signaled the CMC approach appears reasonable, while flagging added comparability work if manufacturing changes.
Study recommendation and meeting cancellation
The 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.
