---
schema_version: "secwatch.filing_event.v1"
accession: "0000950170-24-061087"
form_type: "8-K"
ticker: "NUVL"
cik: "0001861560"
company_name: "Nuvalent, Inc."
filed_at: "2024-05-16T23:59:59+00:00"
generated_at: "2026-06-01T21:43:31.553833+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.8
calibrated_materiality_score: 0.8
confidence: "high"
source: SEC EDGAR
---

# FDA grants Breakthrough Therapy designation to Nuvalent's NVL-655 for ALK+ NSCLC

## Summary
- NVL-655 received FDA Breakthrough Therapy designation for ALK-positive non-small cell lung cancer.
- Designation covers patients with locally advanced or metastatic disease after two or more prior ALK TKIs.
- Breakthrough Therapy status may accelerate development and FDA review for serious conditions.
- Announcement date: May 16, 2024.

## SEC filing metadata
- accession: 0000950170-24-061087
- form_type: 8-K
- ticker: NUVL
- cik: 0001861560
- company_name: Nuvalent, Inc.
- filed_at: 2024-05-16T23:59:59+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/1861560/000095017024061087/0000950170-24-061087-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1861560/000095017024061087/nuvl-20240516.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0000950170-24-061087
- JSON: https://secwatch.observer/filing/0000950170-24-061087.json
- Plain text: https://secwatch.observer/filing/0000950170-24-061087.txt

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