{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-139164","form_type":"8-K","ticker":"NUVB","cik":"0001811063","company_name":"Nuvation Bio Inc.","filed_at":"2025-06-11T23:59:59+00:00","discovered_at":"2026-05-14T18:02:49.821802+00:00","generated_at":"2026-05-19T13:46:12.303214+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Nuvation Bio announces FDA approval of IBTROZI (taletrectinib) for ROS1+ NSCLC","bullets":["FDA approved IBTROZI for adult patients with locally advanced or metastatic ROS1+ NSCLC.","In TRUST-I, cORR of 90% in TKI-naïve patients; TRUST-II cORR of 85%; median DOR not yet reached.","Intracranial response in 73% of TKI-naïve and 63% of TKI-pretreated patients with brain metastases.","Generally well-tolerated; 7% discontinued due to TEAEs; most common AEs: diarrhea (64%), nausea (47%), vomiting (43%).","Approved dose 600 mg once-daily; half-life ~66 hours enabling sustained CNS exposure."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-139164","json":"https://secwatch.observer/filing/0001193125-25-139164.json","markdown":"https://secwatch.observer/filing/0001193125-25-139164.md","text":"https://secwatch.observer/filing/0001193125-25-139164.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1811063/000119312525139164/0001193125-25-139164-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1811063/000119312525139164/d932856d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-19T13:46:12.303214+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"}