NeOnc Technologies Receives Written Feedback From FDA Regarding NEO212 Development
NeOnc Technologies (NTHI) said the FDA provided written feedback on NEO212, a potential treatment for malignant brain tumors and other CNS cancers. FDA said the CMC approach is reasonable but requested additional comparative assessments if manufacturing or physical characteristics change. The agency allowed the drug-product plan to proceed alongside late-stage trials, with stability and a capsule-to-tablet bioavailability study. NTHI shares were $4.03, up 9.51% on Nasdaq.



