---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-25-089213"
form_type: "8-K"
ticker: "NUVL"
cik: "0001861560"
company_name: "Nuvalent, Inc."
filed_at: "2025-06-24T23:59:59+00:00"
generated_at: "2026-05-18T22:57:09.829767+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Nuvalent reports positive pivotal data for zidesamtinib in ROS1+ NSCLC; NDA submission set for July 2025

## Summary
- Zidesamtinib achieved 44% ORR (51/117) in TKI pre-treated ROS1+ NSCLC; intracranial ORR 48% (27/56) with 20% complete responses.
- In TKI-naïve cohort, preliminary ORR 89% (31/35) with intracranial ORR 83% (5/6) and 67% complete responses; 104 patients enrolled.
- FDA agreed to RTOR for zidesamtinib; rolling NDA to start July 2025, completion targeted Q3 2025, for TKI pre-treated advanced NSCLC.
- ALKAZAR Phase 3 trial of neladalkib vs alectinib in ALK+ NSCLC expected to begin enrollment early H2 2025.
- Zidesamtinib well tolerated: 2% discontinued due to TEAEs; median exposure 5 months; common TEAEs included peripheral edema (36%).

## SEC filing metadata
- accession: 0000950170-25-089213
- form_type: 8-K
- ticker: NUVL
- cik: 0001861560
- company_name: Nuvalent, Inc.
- filed_at: 2025-06-24T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1861560/000095017025089213/0000950170-25-089213-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1861560/000095017025089213/nuvl-20250624.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-25-089213
- JSON: https://secwatch.observer/filing/0000950170-25-089213.json
- Plain text: https://secwatch.observer/filing/0000950170-25-089213.txt

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