FDA Meeting Could Put NeOnc's NEO100 Experimental Brain Cancer Drug on Faster Track
Globe Newswire•11/11/2026•08:37 ET
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Key Highlights
- ➤FDA Type B meeting set for January 2027 on NEO100 accelerated approval pathway
- ➤NEO100 Phase 2a PFS-6 reached 48.9%, exceeding 20% historical benchmark
- ➤Proposed Phase 3 trial will compare NEO100 with standard-of-care chemotherapy
- ➤Heshmatpour bought 271,000 shares worth approximately $1.11 million in 2026
- ➤Approximately 920,631 shares sold short, equaling 7.03 days to cover
DENVER, Nov. 11, 2026 (GLOBE NEWSWIRE) -- (247MarketNews) — NeOnc Technologies Holdings (NASDAQ: NTHI) secured a Type B End-of-Phase meeting, scheduled for early January 2027, with the U.S. Food and Drug Administration (FDA), to discuss a potential accelerated approval pathway for its experimental intranasal brain cancer treatment NEO100, putting the company's regulatory strategy in focus as it prepares for a randomized Phase 3 study.
NeOnc intends to seek FDA feedback on whether its existing clinical and nonclinical evidence could support a 505(b)(2) New Drug Application (NDA) seeking accelerated approval for recurrent or progressive IDH-mutant grade 4 astrocytoma.
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