---
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"
generated_at: "2026-05-19T13:46:12.303214+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Nuvation Bio announces FDA approval of IBTROZI (taletrectinib) for ROS1+ NSCLC

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-139164
- JSON: https://secwatch.observer/filing/0001193125-25-139164.json
- Plain text: https://secwatch.observer/filing/0001193125-25-139164.txt

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