{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-26-024041","form_type":"8-K","ticker":"MNPR","cik":"0001645469","company_name":"Monopar Therapeutics","filed_at":"2026-07-22T12:00:09+00:00","discovered_at":"2026-07-22T12:05:00.244921+00:00","generated_at":"2026-07-22T12:05:13.058598+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Monopar initiates rolling NDA submission for ALXN1840 in Wilson disease","bullets":["Rolling NDA submission started; first completed sections submitted to FDA.","ALXN1840 is a first-in-class albumin tripartite complex activator for Wilson disease.","FDA granted Fast Track, Orphan Drug, and Rare Pediatric Disease designations.","Rare Pediatric Disease designation could yield a Priority Review Voucher upon NDA approval.","If approved, would be first novel mechanism therapy for Wilson disease in decades."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-26-024041","json":"https://secwatch.observer/filing/0001437749-26-024041.json","markdown":"https://secwatch.observer/filing/0001437749-26-024041.md","text":"https://secwatch.observer/filing/0001437749-26-024041.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1645469/000143774926024041/0001437749-26-024041-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1645469/000143774926024041/mnpr20260721_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-07-22T12:05:13.058598+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"}