{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-25-283893","form_type":"8-K","ticker":"NUVL","cik":"0001861560","company_name":"Nuvalent, Inc.","filed_at":"2025-11-17T23:59:59+00:00","discovered_at":"2026-05-14T18:02:40.859888+00:00","generated_at":"2026-05-16T19:23:30.786436+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 neladalkib in ALK+ NSCLC; ORR 31% in TKI pre-treated, 46% in lorlatinib-naïve","bullets":["Neladalkib achieved 31% ORR (79/253) in TKI pre-treated ALK+ NSCLC; median DOR not reached at 11.3 months follow-up.","In lorlatinib-naïve subset (n=63), ORR 46% (29/63); DOR ≥12 months 80%. Intracranial ORR 63% with 21% CR.","Preliminary TKI-naïve cohort (n=44): ORR 86% (38/44), CR 9%, intracranial ORR 78% with 44% CR.","Safety consistent with ALK-selective design; most common TEAEs: ALT/AST elevations, constipation, dysgeusia. 5% discontinuation.","Company plans pre-NDA meeting with FDA for TKI pre-treated population; detailed results at future medical meeting."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-25-283893","json":"https://secwatch.observer/filing/0001193125-25-283893.json","markdown":"https://secwatch.observer/filing/0001193125-25-283893.md","text":"https://secwatch.observer/filing/0001193125-25-283893.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1861560/000119312525283893/0001193125-25-283893-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1861560/000119312525283893/d23395d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-16T19:23:30.786436+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"}