NEONC TECHNOLOGIES HOLDINGS, INC. 8K

NeOnc Technologies filed an 8-K to furnish an investor presentation highlighting that its Phase 2a trial of intranasal NEO100 in recurrent IDH1‑mutant grade III–IV glioma met its primary endpoint with strong survival data and will be used to advance a proposed registrational Phase 3 program aimed at Accelerated Approval.

NeOnc Technologies Holdings, Inc. furnished an investor presentation describing positive topline Phase 2a results from its NEO100-01 clinical trial (NCT02704858) of intranasal NEO100 in recurrent or progressive IDH1‑mutant grade III–IV glioma, reporting that the study met its primary endpoint with a 48.9% six‑month progression‑free survival rate versus a 20% historical benchmark and showed a median overall survival of 26.09 months from recurrence—substantially longer than the cited 6–9 month historical salvage‑therapy benchmark—along with generally well-tolerated safety, durable disease control in 66.7% of patients, and five of 24 patients still on treatment; the company outlines plans to use these data to support an End‑of‑Phase‑2/Type B FDA meeting and to propose a single Phase 3 registrational trial (NEO100‑301) intended to seek Accelerated Approval comparing NEO100 to lomustine in recurrent IDH1‑mutant grade 3/4 astrocytoma.

Filing Facts

CIK

1979414

Ticker

-

Form

8K

Source Type

sec

Accession

0001829126-26-008654

Alert Tier

7