---
schema_version: "secwatch.filing_event.v1"
accession: "0001861560-26-000003"
form_type: "8-K"
ticker: "NUVL"
cik: "0001861560"
company_name: "Nuvalent, Inc."
filed_at: "2026-04-07T23:59:59+00:00"
generated_at: "2026-05-15T07:07:17.192901+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Nuvalent submits NDA to FDA for neladalkib in ALK-positive lung cancer

## Summary
- NDA submitted to FDA on April 7, 2026, for neladalkib in TKI pre-treated advanced ALK-positive NSCLC.
- Neladalkib is a novel ALK inhibitor targeting advanced ALK+ non-small cell lung cancer.
- Submission marks regulatory milestone; no additional details on acceptance or review timeline provided.
- Nuvalent (NUVL) expects FDA review of the NDA for potential market approval.

## SEC filing metadata
- accession: 0001861560-26-000003
- form_type: 8-K
- ticker: NUVL
- cik: 0001861560
- company_name: Nuvalent, Inc.
- filed_at: 2026-04-07T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1861560/000186156026000003/0001861560-26-000003-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1861560/000186156026000003/nuvl-20260407.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001861560-26-000003
- JSON: https://secwatch.observer/filing/0001861560-26-000003.json
- Plain text: https://secwatch.observer/filing/0001861560-26-000003.txt

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