---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-25-283893"
form_type: "8-K"
ticker: "NUVL"
cik: "0001861560"
company_name: "Nuvalent, Inc."
filed_at: "2025-11-17T23:59:59+00:00"
generated_at: "2026-05-16T19:23:30.786436+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 neladalkib in ALK+ NSCLC; ORR 31% in TKI pre-treated, 46% in lorlatinib-naïve

## Summary
- Neladalkib achieved 31% ORR (79/253) in TKI pre-treated ALK+ NSCLC; median DOR not reached at 11.3 months follow-up.
- In lorlatinib-naïve subset (n=63), ORR 46% (29/63); DOR ≥12 months 80%. Intracranial ORR 63% with 21% CR.
- Preliminary TKI-naïve cohort (n=44): ORR 86% (38/44), CR 9%, intracranial ORR 78% with 44% CR.
- Safety consistent with ALK-selective design; most common TEAEs: ALT/AST elevations, constipation, dysgeusia. 5% discontinuation.
- Company plans pre-NDA meeting with FDA for TKI pre-treated population; detailed results at future medical meeting.

## SEC filing metadata
- accession: 0001193125-25-283893
- form_type: 8-K
- ticker: NUVL
- cik: 0001861560
- company_name: Nuvalent, Inc.
- filed_at: 2025-11-17T23:59:59+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/1861560/000119312525283893/0001193125-25-283893-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1861560/000119312525283893/d23395d8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-25-283893
- JSON: https://secwatch.observer/filing/0001193125-25-283893.json
- Plain text: https://secwatch.observer/filing/0001193125-25-283893.txt

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