{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-005629","form_type":"8-K","ticker":"NUVL","cik":"0001861560","company_name":"Nuvalent, Inc.","filed_at":"2025-01-14T23:59:59+00:00","discovered_at":"2026-05-14T18:03:05.361874+00:00","generated_at":"2026-05-28T02:18:02.895216+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Nuvalent Plans Initial NDA Submission for Zidesamtinib by Mid-2025 and Reports Pivotal Data Milestones","bullets":["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."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-005629","json":"https://secwatch.observer/filing/0001193125-25-005629.json","markdown":"https://secwatch.observer/filing/0001193125-25-005629.md","text":"https://secwatch.observer/filing/0001193125-25-005629.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1861560/000119312525005629/0001193125-25-005629-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1861560/000119312525005629/d908944d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud","generated_at":"2026-05-28T02:18:02.895216+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}