---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-24-219153"
form_type: "8-K"
ticker: "NUVL"
cik: "0001861560"
company_name: "Nuvalent, Inc."
filed_at: "2024-09-16T23:59:59+00:00"
generated_at: "2026-05-31T04:42:44.971608+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Nuvalent reports promising Phase 1 data for zidesamtinib and NVL-655; pivotal data expected 2025

## Summary
- Zidesamtinib ORR 44% in pre-treated ROS1+ NSCLC; 72% in G2032R mutation subset.
- NVL-655 at RP2D showed ORR 38% in pre-treated ALK+ NSCLC; 64% in compound mutation patients.
- Phase 2 enrollment accelerated: 227 patients in ARROS-1, 229 in ALKOVE-1 as of Sept 1, 2024.
- Phase 3 ALKAZAR trial of NVL-655 vs alectinib in TKI-naïve ALK+ NSCLC to start H1 2025; FDA aligned.
- Pivotal data from both Phase 2 trials now expected in 2025; no discontinuations due to TRAEs for zidesamtinib.

## SEC filing metadata
- accession: 0001193125-24-219153
- form_type: 8-K
- ticker: NUVL
- cik: 0001861560
- company_name: Nuvalent, Inc.
- filed_at: 2024-09-16T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1861560/000119312524219153/0001193125-24-219153-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1861560/000119312524219153/d862522d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-24-219153
- JSON: https://secwatch.observer/filing/0001193125-24-219153.json
- Plain text: https://secwatch.observer/filing/0001193125-24-219153.txt

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