secwatch.observer — SEC 8-K summary
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Issuer:     Nuvalent, Inc. (NUVL)
CIK:        0001861560
Form:       8-K
Filed at:   2025-01-14T23:59:59+00:00
Accession:  0001193125-25-005629
Event type: other_material
Sentiment:  positive
Materiality: 0.80
Item codes: 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud

Nuvalent Plans Initial NDA Submission for Zidesamtinib by Mid-2025 and Reports Pivotal Data Milestones
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- As of Dec 31, 2024, 430 patients enrolled in ARROS-1 trial of zidesamtinib for ROS1-positive NSCLC.
- As of Dec 31, 2024, 596 patients enrolled in ALKOVE-1 trial of neladalkib for ALK-positive NSCLC.
- Topline pivotal data for zidesamtinib expected H1 2025; NDA submission for TKI pre-treated ROS1+ NSCLC by mid-2025.
- Topline pivotal data for neladalkib (NVL-655) expected by year-end 2025; Phase 3 ALKAZAR trial to initiate H1 2025.
- Nuvalent presented at 43rd Annual J.P. Morgan Healthcare Conference on Jan 14, 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1861560/000119312525005629/0001193125-25-005629-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1861560/000119312525005629/d908944d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-005629

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer