---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-23-250724"
form_type: "8-K"
ticker: "NUVL"
cik: "0001861560"
company_name: "Nuvalent, Inc."
filed_at: "2023-10-04T23:59:59+00:00"
generated_at: "2026-06-10T05:00:26.727030+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Nuvalent reports NVL-655 Phase 1 data: 45% ORR in evaluable ALK+ NSCLC patients

## Summary
- 57 patients received 15–200 mg once daily; 51% had baseline CNS metastases; 77% post-lorlatinib.
- ORR 45% (15/33) in evaluable ALK+ NSCLC; 65% (11/17) in patients with ALK resistance mutations.
- 41% ORR (12/29) in post-lorlatinib patients, including those with compound resistance mutations.
- No MTD identified; most common TRAEs: nausea (12%), transaminase elevation (12%), fatigue (9%).
- Updated data to be presented Oct 13 at AACR-NCI-EORTC; company to host conference call that day.

## SEC filing metadata
- accession: 0001193125-23-250724
- form_type: 8-K
- ticker: NUVL
- cik: 0001861560
- company_name: Nuvalent, Inc.
- filed_at: 2023-10-04T23:59:59+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/1861560/000119312523250724/0001193125-23-250724-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1861560/000119312523250724/d541910d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-23-250724
- JSON: https://secwatch.observer/filing/0001193125-23-250724.json
- Plain text: https://secwatch.observer/filing/0001193125-23-250724.txt

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