{"filing":{"accession_number":"0001104659-26-100071","cik":"0001133869","ticker":"CAPR","company_name":"CAPRICOR THERAPEUTICS, INC.","form":"8-K","filing_date":"2026-08-24","report_date":"2026-08-24","primary_document":"capr-20260824x8k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1133869/000110465926100071/capr-20260824x8k.htm"},"events":[{"id":29100,"run_id":26627,"accession_number":"0001104659-26-100071","anchor_item_number":"8.01","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"summary":"The FDA has extended the PDUFA target action date for Deramiocel's BLA from August 22, 2026 to November 22, 2026, classifying the submission as a major amendment following submission of 24-month open-label extension data from the Phase 3 HOPE-3 study. This is a material regulatory milestone affecting the timeline for a potential product approval, but does not fit neatly into specific categories like earnings_release, ma_activity, or material_litigation. The event is clearly operational/strategic in nature—a regulatory development in the drug approval process—making operational_other the most appropriate classification.","company_name":"CAPRICOR THERAPEUTICS, INC.","ticker":"CAPR","filing_date":"2026-08-24","form":"8-K","submitted_at":null,"items":[{"id":31264,"accession_number":"0001104659-26-100071","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The FDA has extended the PDUFA target action date for Deramiocel's BLA from August 22, 2026 to November 22, 2026, classifying the submission as a major amendment following submission of 24-month open-label extension data from the Phase 3 HOPE-3 study. This is a material regulatory milestone affecting the timeline for a potential product approval, but does not fit neatly into specific categories like earnings_release, ma_activity, or material_litigation. The event is clearly operational/strategic in nature—a regulatory development in the drug approval process—making operational_other the most appropriate classification.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-08-24T13:26:43.824658+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":31264,"accession_number":"0001104659-26-100071","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The FDA has extended the PDUFA target action date for Deramiocel's BLA from August 22, 2026 to November 22, 2026, classifying the submission as a major amendment following submission of 24-month open-label extension data from the Phase 3 HOPE-3 study. This is a material regulatory milestone affecting the timeline for a potential product approval, but does not fit neatly into specific categories like earnings_release, ma_activity, or material_litigation. The event is clearly operational/strategic in nature—a regulatory development in the drug approval process—making operational_other the most appropriate classification.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-08-24T13:26:43.824658+00:00","company_name":"CAPRICOR THERAPEUTICS, INC.","ticker":"CAPR","filing_date":"2026-08-24"}]}