{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-088667","form_type":"8-K","ticker":"CAPR","cik":"0001133869","company_name":"CAPRICOR THERAPEUTICS, INC.","filed_at":"2026-07-30T20:05:11+00:00","discovered_at":"2026-07-30T20:06:18.375453+00:00","generated_at":"2026-07-30T20:07:07.072389+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"FDA advisory panel votes 9-3 against Deramiocel effectiveness for DMD cardiomyopathy","bullets":["FDA CTGT Advisory Committee voted 9-3 that evidence did not support Deramiocel's effectiveness for DMD cardiomyopathy; vote is non-binding.","PDUFA target action date remains August 22, 2026; FDA will consider committee recommendation in BLA review.","Committee's voting question addressed a narrower indication than Capricor proposed; no vote on overall benefit-risk.","In separate discussion, committee gave directionally supportive feedback on upper limb function from HOPE-3 trial.","CEO Linda Marbán expressed commitment to Deramiocel and confidence in HOPE-3 data; patients and families shared support."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-088667","json":"https://secwatch.observer/filing/0001104659-26-088667.json","markdown":"https://secwatch.observer/filing/0001104659-26-088667.md","text":"https://secwatch.observer/filing/0001104659-26-088667.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1133869/000110465926088667/0001104659-26-088667-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1133869/000110465926088667/capr-20260729x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-07-30T20:07:07.072389+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"}