---
schema_version: "secwatch.filing_event.v1"
accession: "0001193125-26-012243"
form_type: "8-K"
ticker: "NUVL"
cik: "0001861560"
company_name: "Nuvalent, Inc."
filed_at: "2026-01-14T23:59:59+00:00"
generated_at: "2026-05-16T10:26:17.910062+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# Nuvalent reports $1.4B cash, zidesamtinib PDUFA Sep 18, 2026; pipeline milestones

## Summary
- Preliminary cash, cash equivalents and securities ~$1.4B as of Dec 31, 2025; runway into 2029.
- FDA accepted NDA for zidesamtinib in TKI pre-treated ROS1+ NSCLC; PDUFA Sep 18, 2026.
- NDA submission for neladalkib in TKI pre-treated ALK+ NSCLC planned for H1 2026.
- Potential indication expansion submission for zidesamtinib in TKI-naïve ROS1+ NSCLC in H2 2026.
- Progressing ALKAZAR Phase 3 (neladalkib, TKI-naïve ALK+) and HEROEX-1 Phase 1a/1b (NVL-330, HER2-altered NSCLC).

## SEC filing metadata
- accession: 0001193125-26-012243
- form_type: 8-K
- ticker: NUVL
- cik: 0001861560
- company_name: Nuvalent, Inc.
- filed_at: 2026-01-14T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.8
- calibrated_materiality_score: 0.8
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1861560/000119312526012243/0001193125-26-012243-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1861560/000119312526012243/nuvl-20240108.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001193125-26-012243
- JSON: https://secwatch.observer/filing/0001193125-26-012243.json
- Plain text: https://secwatch.observer/filing/0001193125-26-012243.txt

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