{"filing":{"accession_number":"0001437749-26-022086","cik":"0001645469","ticker":"MNPR","company_name":"Monopar Therapeutics","form":"8-K","filing_date":"2026-06-30","report_date":null,"primary_document":"mnpr20260629_8k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1645469/000143774926022086/mnpr20260629_8k.htm"},"events":[{"id":14841,"run_id":13232,"accession_number":"0001437749-26-022086","anchor_item_number":"7.01","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"summary":"Monopar announced that the FDA granted Rare Pediatric Disease (RPD) designation to ALXN1840 for Wilson disease treatment. This is a regulatory milestone that provides potential access to a pediatric Priority Review Voucher (PRV) upon NDA approval, which could accelerate future regulatory reviews. While this is a positive development for a clinical-stage biopharmaceutical company's lead candidate, it is a regulatory/operational milestone rather than a specific named event type (not earnings, M\u0026A, impairment, litigation, etc.). The designation is material to investors as it enhances the value proposition of the company's pipeline and provides a tangible regulatory pathway advantage.","company_name":"Monopar Therapeutics","ticker":"MNPR","filing_date":"2026-06-30","form":"8-K","submitted_at":null,"items":[{"id":12401,"accession_number":"0001437749-26-022086","item_number":"7.01","item_title":"Regulation FD Disclosure","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"Monopar announced that the FDA granted Rare Pediatric Disease (RPD) designation to ALXN1840 for Wilson disease treatment. This is a regulatory milestone that provides potential access to a pediatric Priority Review Voucher (PRV) upon NDA approval, which could accelerate future regulatory reviews. While this is a positive development for a clinical-stage biopharmaceutical company's lead candidate, it is a regulatory/operational milestone rather than a specific named event type (not earnings, M\u0026A, impairment, litigation, etc.). The designation is material to investors as it enhances the value proposition of the company's pipeline and provides a tangible regulatory pathway advantage.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-06-30T12:01:37.816840+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":12401,"accession_number":"0001437749-26-022086","item_number":"7.01","item_title":"Regulation FD Disclosure","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"Monopar announced that the FDA granted Rare Pediatric Disease (RPD) designation to ALXN1840 for Wilson disease treatment. This is a regulatory milestone that provides potential access to a pediatric Priority Review Voucher (PRV) upon NDA approval, which could accelerate future regulatory reviews. While this is a positive development for a clinical-stage biopharmaceutical company's lead candidate, it is a regulatory/operational milestone rather than a specific named event type (not earnings, M\u0026A, impairment, litigation, etc.). The designation is material to investors as it enhances the value proposition of the company's pipeline and provides a tangible regulatory pathway advantage.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-06-30T12:01:37.816840+00:00","company_name":"Monopar Therapeutics","ticker":"MNPR","filing_date":"2026-06-30"}]}