{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-23-255616","form_type":"8-K","ticker":"NUVL","cik":"0001861560","company_name":"Nuvalent, Inc.","filed_at":"2023-10-13T23:59:59+00:00","discovered_at":"2026-05-14T18:03:31.166277+00:00","generated_at":"2026-06-10T00:14:05.360987+00:00","sec_items":["8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Nuvalent reports Phase 1 ALKOVE-1 data: NVL-655 shows 39% ORR in heavily pre-treated ALK+ NSCLC","bullets":["ORR 39% (20/51) in response-evaluable NSCLC patients; 44% (18/41) at ≥50 mg QD dose levels.","Activity in CNS metastases subgroup: ORR 52% (15/29); all responders continued without CNS progression.","Patients with ALK G1202R mutations had 71% ORR (12/17); compound mutations ORR 56% (9/16).","Favorable safety: 2% discontinuations, 5% dose reductions; no TRK-related neurotoxicities; MTD not reached.","100% clearance of ALK resistance mutations in 14/16 patients with G1202R or I1171X mutations by ctDNA."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-23-255616","json":"https://secwatch.observer/filing/0001193125-23-255616.json","markdown":"https://secwatch.observer/filing/0001193125-23-255616.md","text":"https://secwatch.observer/filing/0001193125-23-255616.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1861560/000119312523255616/0001193125-23-255616-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1861560/000119312523255616/d558552d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-10T00:14:05.360987+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"}