{"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","discovered_at":"2026-05-14T18:02:40.544771+00:00","generated_at":"2026-05-16T19:21:53.019999+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Nuvation Bio reports Phase 2 ORR 44.4% for safusidenib in IDH1-mutant gliomas","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-284845","json":"https://secwatch.observer/filing/0001193125-25-284845.json","markdown":"https://secwatch.observer/filing/0001193125-25-284845.md","text":"https://secwatch.observer/filing/0001193125-25-284845.txt","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"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T19:21:53.019999+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}