---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-005629"
form_type: "8-K"
ticker: "NUVL"
cik: "0001861560"
company_name: "Nuvalent, Inc."
filed_at: "2025-01-14T23:59:59+00:00"
generated_at: "2026-05-28T02:18:02.895216+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Nuvalent Plans Initial NDA Submission for Zidesamtinib by Mid-2025 and Reports Pivotal Data Milestones

## Summary
- As of Dec 31, 2024, 430 patients enrolled in ARROS-1 trial of zidesamtinib for ROS1-positive NSCLC.
- As of Dec 31, 2024, 596 patients enrolled in ALKOVE-1 trial of neladalkib for ALK-positive NSCLC.
- Topline pivotal data for zidesamtinib expected H1 2025; NDA submission for TKI pre-treated ROS1+ NSCLC by mid-2025.
- Topline pivotal data for neladalkib (NVL-655) expected by year-end 2025; Phase 3 ALKAZAR trial to initiate H1 2025.
- Nuvalent presented at 43rd Annual J.P. Morgan Healthcare Conference on Jan 14, 2025.

## SEC filing metadata
- accession: 0001193125-25-005629
- form_type: 8-K
- ticker: NUVL
- cik: 0001861560
- company_name: Nuvalent, Inc.
- filed_at: 2025-01-14T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1861560/000119312525005629/0001193125-25-005629-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1861560/000119312525005629/d908944d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-005629
- JSON: https://secwatch.observer/filing/0001193125-25-005629.json
- Plain text: https://secwatch.observer/filing/0001193125-25-005629.txt

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