---
schema_version: "secwatch.filing_event.v1"
accession: "0001861560-26-000020"
form_type: "8-K"
ticker: "NUVL"
cik: "0001861560"
company_name: "Nuvalent, Inc."
filed_at: "2026-05-07T23:59:59+00:00"
generated_at: "2026-05-14T22:02:04.384865+00:00"
event_type: "other_material"
sentiment: "neutral"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Nuvalent submits NDA for neladalkib in ALK+ NSCLC; zidesamtinib PDUFA Sept 18, 2026

## Summary
- NDA for neladalkib in TKI pre-treated ALK+ NSCLC submitted; pivotal data at ASCO 2026.
- Zidesamtinib NDA under FDA review; PDUFA target action date September 18, 2026.
- Plan to submit data in 2H 2026 for zidesamtinib label expansion in TKI-naïve ROS1+ NSCLC.
- Cash $1.3B; net loss $109.3M in Q1 2026 (R&D $83.6M, G&A $35.8M).
- Leadership promotions: Dr. Benjamin Lane to Chief Technology Operations Officer; Dr. Kirsten Duncan to VP Medical Affairs.

## SEC filing metadata
- accession: 0001861560-26-000020
- form_type: 8-K
- ticker: NUVL
- cik: 0001861560
- company_name: Nuvalent, Inc.
- filed_at: 2026-05-07T23:59:59+00:00
- event_type: other_material
- sentiment: neutral
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 2.02, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1861560/000186156026000020/0001861560-26-000020-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1861560/000186156026000020/nuvl-20260507.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001861560-26-000020
- JSON: https://secwatch.observer/filing/0001861560-26-000020.json
- Plain text: https://secwatch.observer/filing/0001861560-26-000020.txt

## Key facts
- Earnings Releases
  Nuvalent, Inc. reported financial results for first quarter 2026.
  - Period: first quarter 2026
  - Result: reported results
  source text: Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today outlined pipeline progress, reiterated key anticipated milestones, and reported first quarter 2026 financial results.
  evidence_url: https://www.sec.gov/Archives/edgar/data/1861560/000186156026000020/0001861560-26-000020-index.htm

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