{"schema_version":"secwatch.filing_event.v1","accession":"0000950170-24-061087","form_type":"8-K","ticker":"NUVL","cik":"0001861560","company_name":"Nuvalent, Inc.","filed_at":"2024-05-16T23:59:59+00:00","discovered_at":"2026-05-14T18:03:20.953694+00:00","generated_at":"2026-06-01T21:43:31.553833+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"FDA grants Breakthrough Therapy designation to Nuvalent's NVL-655 for ALK+ NSCLC","bullets":["NVL-655 received FDA Breakthrough Therapy designation for ALK-positive non-small cell lung cancer.","Designation covers patients with locally advanced or metastatic disease after two or more prior ALK TKIs.","Breakthrough Therapy status may accelerate development and FDA review for serious conditions.","Announcement date: May 16, 2024."],"urls":{"canonical":"https://secwatch.observer/filing/0000950170-24-061087","json":"https://secwatch.observer/filing/0000950170-24-061087.json","markdown":"https://secwatch.observer/filing/0000950170-24-061087.md","text":"https://secwatch.observer/filing/0000950170-24-061087.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1861560/000095017024061087/0000950170-24-061087-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1861560/000095017024061087/nuvl-20240516.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T21:43:31.553833+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"}