{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-26-012751","form_type":"8-K","ticker":"MNPR","cik":"0001645469","company_name":"Monopar Therapeutics","filed_at":"2026-04-20T23:59:59+00:00","discovered_at":"2026-05-14T18:02:32.651674+00:00","generated_at":"2026-05-15T05:20:01.950631+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Monopar Phase 3 ALXN1840 data shows greater neurologic benefit vs SoC in Wilson disease","bullets":["Neurologic worsening at Week 48: 9% ALXN1840 vs 25% SoC (p=0.038); improvement 45% vs 32%.","CGI-S improvement from baseline to Week 48: 61% ALXN1840 vs 17% SoC (p=0.008); CGI-I 47% vs 19% (p=0.003).","Durable neurologic benefit over ~3 years in long-term follow-up; consistent across treatment-naïve and experienced.","Safety: drug-related SAEs 4.9%; neurologic SAEs <1%; no treatment-related deaths.","NDA submission to FDA planned for mid-2026 based on these results."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-26-012751","json":"https://secwatch.observer/filing/0001437749-26-012751.json","markdown":"https://secwatch.observer/filing/0001437749-26-012751.md","text":"https://secwatch.observer/filing/0001437749-26-012751.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1645469/000143774926012751/0001437749-26-012751-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1645469/000143774926012751/mnpr20260419_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-15T05:20:01.950631+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"}