---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-048529"
form_type: "8-K"
ticker: "NUVB"
cik: "0001811063"
company_name: "Nuvation Bio Inc."
filed_at: "2025-03-06T23:59:59+00:00"
generated_at: "2026-05-25T07:12:41.269704+00:00"
event_type: "earnings"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Nuvation Bio: taletrectinib NDA Priority Review, $250M financing, Q4 net loss $49.4M

## Summary
- FDA accepted NDA for taletrectinib with Priority Review; PDUFA goal date June 23, 2025 for advanced ROS1+ NSCLC.
- Secured up to $250M non-dilutive financings from Sagard: $150M royalty interest plus $50M debt upon FDA approval.
- Q4 net loss $49.4M ($0.15/sh) vs $13.8M ($0.06) in Q4 2023; R&D and SG&A rose due to AnHeart acquisition.
- China NMPA approved taletrectinib Jan 2025 (Innovent commercializing); Nippon Kayaku submitted MAA in Japan.
- Launched U.S. Expanded Access Program for taletrectinib in February 2025.

## SEC filing metadata
- accession: 0001193125-25-048529
- form_type: 8-K
- ticker: NUVB
- cik: 0001811063
- company_name: Nuvation Bio Inc.
- filed_at: 2025-03-06T23:59:59+00:00
- event_type: earnings
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1811063/000119312525048529/0001193125-25-048529-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1811063/000119312525048529/d910737d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-048529
- JSON: https://secwatch.observer/filing/0001193125-25-048529.json
- Plain text: https://secwatch.observer/filing/0001193125-25-048529.txt

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