{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-22-271664","form_type":"8-K","ticker":"NUVL","cik":"0001861560","company_name":"Nuvalent, Inc.","filed_at":"2022-10-28T23:59:59+00:00","discovered_at":"2026-05-14T18:03:52.820082+00:00","generated_at":"2026-06-22T22:55:09.889431+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 preliminary Phase 1 data for NVL-520: 48% ORR in heavily pre-treated ROS1+ NSCLC","bullets":["48% ORR (10/21) in heavily pre-treated ROS1+ NSCLC; 78% (7/9) in G2032R mutation patients.","Intracranial PRs in 100% (3/3) with measurable CNS mets; 73% (8/11) with CNS history.","No DLTs, treatment-related SAEs, dizziness, or AEs leading to dose reduction/discontinuation in 35 patients.","Dose levels 25-125 mg QD achieved exposures above target thresholds; half-life supports once-daily dosing.","Phase 1 enrollment ongoing; 76% (16/21) of response-evaluable patients continue treatment."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-22-271664","json":"https://secwatch.observer/filing/0001193125-22-271664.json","markdown":"https://secwatch.observer/filing/0001193125-22-271664.md","text":"https://secwatch.observer/filing/0001193125-22-271664.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1861560/000119312522271664/0001193125-22-271664-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1861560/000119312522271664/d377694d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-22T22:55:09.889431+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"}