secwatch.observer — SEC 8-K summary
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Issuer:     Nuvation Bio Inc. (NUVB)
CIK:        0001811063
Form:       8-K
Filed at:   2025-11-17T23:59:59+00:00
Accession:  0001193125-25-284845
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

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

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1811063/000119312525284845/0001193125-25-284845-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1811063/000119312525284845/d845081d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-284845

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