---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-209934"
form_type: "8-K"
ticker: "NUVL"
cik: "0001861560"
company_name: "Nuvalent, Inc."
filed_at: "2025-09-22T23:59:59+00:00"
generated_at: "2026-05-17T06:00:22.180973+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# Nuvalent completes NDA submission to FDA for zidesamtinib in ROS1-positive NSCLC

## Summary
- Completed NDA submission to FDA for zidesamtinib.
- Indication: TKI pre-treated advanced ROS1-positive non-small cell lung cancer.
- Submission date: September 22, 2025.

## SEC filing metadata
- accession: 0001193125-25-209934
- form_type: 8-K
- ticker: NUVL
- cik: 0001861560
- company_name: Nuvalent, Inc.
- filed_at: 2025-09-22T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1861560/000119312525209934/0001193125-25-209934-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1861560/000119312525209934/nuvl-20250922.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-209934
- JSON: https://secwatch.observer/filing/0001193125-25-209934.json
- Plain text: https://secwatch.observer/filing/0001193125-25-209934.txt

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