{"schema_version":"secwatch.filing_event.v1","accession":"0001861560-26-000020","form_type":"8-K","ticker":"NUVL","cik":"0001861560","company_name":"Nuvalent, Inc.","filed_at":"2026-05-07T23:59:59+00:00","discovered_at":"2026-05-14T18:02:33.169845+00:00","generated_at":"2026-05-14T22:02:04.384865+00:00","sec_items":["2.02","9.01"],"event_type":"other_material","sentiment":"neutral","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Nuvalent submits NDA for neladalkib in ALK+ NSCLC; zidesamtinib PDUFA Sept 18, 2026","bullets":["NDA for neladalkib in TKI pre-treated ALK+ NSCLC submitted; pivotal data at ASCO 2026.","Zidesamtinib NDA under FDA review; PDUFA target action date September 18, 2026.","Plan to submit data in 2H 2026 for zidesamtinib label expansion in TKI-naïve ROS1+ NSCLC.","Cash $1.3B; net loss $109.3M in Q1 2026 (R&D $83.6M, G&A $35.8M).","Leadership promotions: Dr. Benjamin Lane to Chief Technology Operations Officer; Dr. Kirsten Duncan to VP Medical Affairs."],"urls":{"canonical":"https://secwatch.observer/filing/0001861560-26-000020","json":"https://secwatch.observer/filing/0001861560-26-000020.json","markdown":"https://secwatch.observer/filing/0001861560-26-000020.md","text":"https://secwatch.observer/filing/0001861560-26-000020.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1861560/000186156026000020/0001861560-26-000020-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1861560/000186156026000020/nuvl-20260507.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-14T22:02:04.384865+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":[{"claim_id":"1f8ca193f96a5ba0f0071f4c5645420b846f4310","claim":"Nuvalent, Inc. reported financial results for first quarter 2026.","evidence_excerpt":"Nuvalent, Inc. (Nasdaq: NUVL), a clinical-stage biopharmaceutical company focused on creating precisely targeted therapies for clinically proven kinase targets in cancer, today outlined pipeline progress, reiterated key anticipated milestones, and reported first quarter 2026 financial results.","evidence_source":"SEC 8-K Item 2.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1861560/000186156026000020/0001861560-26-000020-index.htm","confidence":0.85,"family_label":"Earnings Releases","details":[{"label":"Period","value":"first quarter 2026"},{"label":"Result","value":"reported results"}],"fact_type":"earnings_release"}],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}