Other Events ·
NeOnc to meet FDA Nov 17 on NEO212 CNS cancer program after selecting 610 mg as recommended Phase 2 dose
NTHINeonc Technologies Holdings, Inc.
NeOnc Technologies Holdings announced a press release scheduling an in-person End-of-Phase 1 Type B meeting with the U.S. Food and Drug Administration for November 17, 2026, concerning its investigational drug NEO212. The company plans to seek FDA feedback on clinical development program updates, including patient population, trial design, endpoints, dose selection, and evidence needed for future marketing applications. This follows the completion of Phase 1 dose-escalation, where 610 mg was selected as the recommended Phase 2 dose after dose-limiting toxicity at 810 mg. The filing is not material as it merely announces a scheduled regulatory discussion without confirming trial designs or approvals. NeOnc Technologies Holdings operates in the biopharmaceutical industry and develops therapies for central nervous system cancers.