---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-284845"
form_type: "8-K"
ticker: "NUVB"
cik: "0001811063"
company_name: "Nuvation Bio Inc."
filed_at: "2025-11-17T23:59:59+00:00"
generated_at: "2026-05-16T19:21:53.019999+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Nuvation Bio reports Phase 2 ORR 44.4% for safusidenib in IDH1-mutant gliomas

## Summary
- Safusidenib met primary endpoint with 44.4% objective response rate in 27 Japanese patients with grade 2 IDH1-mutant gliomas.
- Median PFS not reached at median 28 months follow-up; 87.9% progression-free at 24 months.
- Grade 3+ treatment-related adverse events in 18.5% of patients; no grade 5 events; GCP noncompliance on safety reporting resolved via re-collection.
- Company progressing G203 global Phase 3 study for high-risk IDH1-mutant glioma; FDA agreed PFS by BICR per RANO 2.0 could support full approval.

## SEC filing metadata
- accession: 0001193125-25-284845
- form_type: 8-K
- ticker: NUVB
- cik: 0001811063
- company_name: Nuvation Bio Inc.
- filed_at: 2025-11-17T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1811063/000119312525284845/0001193125-25-284845-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1811063/000119312525284845/d845081d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-284845
- JSON: https://secwatch.observer/filing/0001193125-25-284845.json
- Plain text: https://secwatch.observer/filing/0001193125-25-284845.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.