{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-25-089213","form_type":"8-K","ticker":"NUVL","cik":"0001861560","company_name":"Nuvalent, Inc.","filed_at":"2025-06-24T23:59:59+00:00","discovered_at":"2026-05-14T18:02:50.230017+00:00","generated_at":"2026-05-18T22:57:09.829767+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Nuvalent reports positive pivotal data for zidesamtinib in ROS1+ NSCLC; NDA submission set for July 2025","bullets":["Zidesamtinib achieved 44% ORR (51/117) in TKI pre-treated ROS1+ NSCLC; intracranial ORR 48% (27/56) with 20% complete responses.","In TKI-naïve cohort, preliminary ORR 89% (31/35) with intracranial ORR 83% (5/6) and 67% complete responses; 104 patients enrolled.","FDA agreed to RTOR for zidesamtinib; rolling NDA to start July 2025, completion targeted Q3 2025, for TKI pre-treated advanced NSCLC.","ALKAZAR Phase 3 trial of neladalkib vs alectinib in ALK+ NSCLC expected to begin enrollment early H2 2025.","Zidesamtinib well tolerated: 2% discontinued due to TEAEs; median exposure 5 months; common TEAEs included peripheral edema (36%)."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-25-089213","json":"https://secwatch.observer/filing/0000950170-25-089213.json","markdown":"https://secwatch.observer/filing/0000950170-25-089213.md","text":"https://secwatch.observer/filing/0000950170-25-089213.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1861560/000095017025089213/0000950170-25-089213-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1861560/000095017025089213/nuvl-20250624.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-18T22:57:09.829767+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"}