NeOnc Plans FDA Discussions On NEO212 Clinical Development And Potential Approval Pathway

India, Sept. 28 -- NeOnc Technologies Holdings, Inc. (NTHI) announced that it is scheduled to meet with the U.S. Food and Drug Administration (FDA) on November 17, 2026, for an in-person End-of-Phase 1 Type B meeting concerning NEO212.

The meeting will focus on the company's NEO212 clinical development program, including the proposed patient population, trial design, endpoints, dose selection and evidence needed to support a future marketing application.

NeOnc said the meeting will provide an opportunity to seek FDA feedback on its planned Phase 2 development and potential regulatory pathways.

The meeting follows completion of the Phase 1 dose-escalation portion of the NEO212-01 Phase 1/2 clinical trial.

During dose escalation, a dose-l...