{"schema_version":"secwatch.filing_event.v1","accession":"0001193125-24-262125","form_type":"8-K","ticker":"NAMS","cik":"0001936258","company_name":"NewAmsterdam Pharma Co N.V.","filed_at":"2024-11-20T23:59:59+00:00","discovered_at":"2026-05-14T18:03:10.381299+00:00","generated_at":"2026-05-29T22:08:30.177539+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"NewAmsterdam Pharma reports positive Phase 3 TANDEM topline data; FDC lowers LDL-C 48.6% vs placebo","bullets":["Fixed-dose combination of obicetrapib 10 mg and ezetimibe 10 mg achieved LS mean LDL-C reduction of 48.6% (p<0.0001) vs placebo at day 84.","All co-primary endpoints met with statistical significance; FDC superior to both monotherapies (p<0.001).","Over 60% of FDC patients saw >50% LDL-C reduction; ~71% achieved LDL-C <55 mg/dL.","Safety well-tolerated; drug-related TEAEs 2.9% in FDC arm vs 3.9% placebo; no serious TEAEs.","Data supports global regulatory filings for the FDC tablet."],"urls":{"canonical":"https://secwatch.observer/filing/0001193125-24-262125","json":"https://secwatch.observer/filing/0001193125-24-262125.json","markdown":"https://secwatch.observer/filing/0001193125-24-262125.md","text":"https://secwatch.observer/filing/0001193125-24-262125.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1936258/000119312524262125/0001193125-24-262125-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1936258/000119312524262125/d868860d8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-29T22:08:30.177539+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"}