{"schema_version":"secwatch.filing_event.v1","accession":"0001861560-26-000003","form_type":"8-K","ticker":"NUVL","cik":"0001861560","company_name":"Nuvalent, Inc.","filed_at":"2026-04-07T23:59:59+00:00","discovered_at":"2026-05-14T18:02:33.169573+00:00","generated_at":"2026-05-15T07:07:17.192901+00:00","sec_items":["8.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Nuvalent submits NDA to FDA for neladalkib in ALK-positive lung cancer","bullets":["NDA submitted to FDA on April 7, 2026, for neladalkib in TKI pre-treated advanced ALK-positive NSCLC.","Neladalkib is a novel ALK inhibitor targeting advanced ALK+ non-small cell lung cancer.","Submission marks regulatory milestone; no additional details on acceptance or review timeline provided.","Nuvalent (NUVL) expects FDA review of the NDA for potential market approval."],"urls":{"canonical":"https://secwatch.observer/filing/0001861560-26-000003","json":"https://secwatch.observer/filing/0001861560-26-000003.json","markdown":"https://secwatch.observer/filing/0001861560-26-000003.md","text":"https://secwatch.observer/filing/0001861560-26-000003.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1861560/000186156026000003/0001861560-26-000003-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1861560/000186156026000003/nuvl-20260407.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T07:07:17.192901+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"}