{"filing":{"accession_number":"0001104659-26-088667","cik":"0001133869","ticker":"CAPR","company_name":"CAPRICOR THERAPEUTICS, INC.","form":"8-K","filing_date":"2026-07-30","report_date":"2026-07-29","primary_document":"capr-20260729x8k.htm","primary_document_url":"https://www.sec.gov/Archives/edgar/data/1133869/000110465926088667/capr-20260729x8k.htm"},"events":[{"id":22564,"run_id":20414,"accession_number":"0001104659-26-088667","anchor_item_number":"8.01","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"summary":"The FDA Advisory Committee voted 9-3 against the effectiveness of Deramiocel for cardiomyopathy in DMD patients, a material regulatory setback for Capricor's lead product candidate. While the vote is non-binding and the FDA will make the final decision by August 22, 2026, this negative advisory committee recommendation materially affects the company's regulatory pathway and investor assessment of approval prospects. This is a regulatory/operational milestone that does not fit the specific categories of restatement, auditor change, going concern, impairment, or litigation, but clearly represents a material operational event affecting the company's primary development program.","company_name":"CAPRICOR THERAPEUTICS, INC.","ticker":"CAPR","filing_date":"2026-07-30","form":"8-K","submitted_at":null,"items":[{"id":22541,"accession_number":"0001104659-26-088667","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The FDA Advisory Committee voted 9-3 against the effectiveness of Deramiocel for cardiomyopathy in DMD patients, a material regulatory setback for Capricor's lead product candidate. While the vote is non-binding and the FDA will make the final decision by August 22, 2026, this negative advisory committee recommendation materially affects the company's regulatory pathway and investor assessment of approval prospects. This is a regulatory/operational milestone that does not fit the specific categories of restatement, auditor change, going concern, impairment, or litigation, but clearly represents a material operational event affecting the company's primary development program.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-08-01T02:19:40.300762+00:00","company_name":"","ticker":null,"filing_date":""}]}],"classifications":[{"id":22541,"accession_number":"0001104659-26-088667","item_number":"8.01","item_title":"Other Events.","event_type":"operational_other","event_domain":"operational","is_material":true,"confidence":0.75,"reasoning":"The FDA Advisory Committee voted 9-3 against the effectiveness of Deramiocel for cardiomyopathy in DMD patients, a material regulatory setback for Capricor's lead product candidate. While the vote is non-binding and the FDA will make the final decision by August 22, 2026, this negative advisory committee recommendation materially affects the company's regulatory pathway and investor assessment of approval prospects. This is a regulatory/operational milestone that does not fit the specific categories of restatement, auditor change, going concern, impairment, or litigation, but clearly represents a material operational event affecting the company's primary development program.","classifier_version":"claude-haiku-4-5-20251001+prompt-a85dd512","taxonomy_version":"v1.3","classified_at":"2026-08-01T02:19:40.300762+00:00","company_name":"CAPRICOR THERAPEUTICS, INC.","ticker":"CAPR","filing_date":"2026-07-30"}]}