NeOnc’s Powerful Brain Cancer Pipeline Advances
Key Highlights
- ➤Nov. 17 FDA End-of-Phase 1 meeting targets NEO212’s Phase 2 design
- ➤NEO212 recommended Phase 2 dose set at 610 mg
- ➤NEO100 six-month progression-free survival 48.9%, beats 20% benchmark
- ➤NeOnc (NTHI) completes $15 million registered direct offering at $4.20
- ➤Roth Capital initiates coverage with $20 price target
Expert Statements
Amir Heshmatpour, CEO of NeOnc Technologies Holdings
“This meeting will help us understand FDA’s feedback on the population, study design and endpoints for the next stage of development.”
DALLAS, Sept. 29, 2026 (GLOBE NEWSWIRE) -- (www.InvestorsTape.com) -- NeOnc Technologies Holdings (NASDAQ: NTHI) is heading toward another potentially important regulatory milestone, with the U.S. Food and Drug Administration scheduled to meet with the company on November 17, 2026, for an in-person End-of-Phase 1 Type B meeting concerning NEO212, its oral perillyl alcohol-temozolomide conjugate being developed for aggressive central nervous system cancers.
NeOnc plans to seek agency feedback on the proposed patient population, Phase 2 trial design, endpoints, dose selection and the evidence that could ultimately support a future marketing application. The company also intends to discuss potential registrational strategies and whether a future study could potentially support an accelerated-approval pathway.
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