{"schema_version":"secwatch.filing_event.v1","accession":"0001437749-26-022086","form_type":"8-K","ticker":"MNPR","cik":"0001645469","company_name":"Monopar Therapeutics","filed_at":"2026-06-30T12:00:16+00:00","discovered_at":"2026-06-30T12:05:07.473468+00:00","generated_at":"2026-06-30T12:05:37.755762+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.55,"calibrated_materiality_score":0.55,"confidence":"high","headline":"Monopar receives FDA Rare Pediatric Disease designation for ALXN1840 in Wilson disease","bullets":["FDA granted Rare Pediatric Disease (RPD) designation to ALXN1840 (tiomolibdate choline) for Wilson disease.","RPD designation is for therapies treating serious/life-threatening diseases primarily affecting children under 18.","Upon NDA approval, Monopar may receive a pediatric Priority Review Voucher (PRV).","PRV can be used for priority review of a subsequent application or sold/transferred to another sponsor.","CEO Chandler Robinson noted the designation underscores the serious impact of Wilson disease."],"urls":{"canonical":"https://secwatch.observer/filing/0001437749-26-022086","json":"https://secwatch.observer/filing/0001437749-26-022086.json","markdown":"https://secwatch.observer/filing/0001437749-26-022086.md","text":"https://secwatch.observer/filing/0001437749-26-022086.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1645469/000143774926022086/0001437749-26-022086-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1645469/000143774926022086/mnpr20260629_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-30T12:05:37.755762+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"}