{"schema_version":"secwatch.filing_event.v1","accession":"0001104659-26-059380","form_type":"8-K","ticker":"CAPR","cik":"0001133869","company_name":"CAPRICOR THERAPEUTICS, INC.","filed_at":"2026-05-12T20:06:21+00:00","discovered_at":"2026-05-12T20:08:00.302384+00:00","generated_at":"2026-05-12T21:29:10.085088+00:00","sec_items":["2.02","9.01"],"event_type":"earnings","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Capricor Q1 net loss $33.9M ($0.59/share); Deramiocel BLA PDUFA Aug 22, 2026","bullets":["Net loss of $33.9M ($0.59/share) for Q1 2026 vs net loss of $24.4M ($0.53/share) in Q1 2025.","Cash balance of $278.6M as of March 31, 2026; expected to support operations through Q4 2027.","Deramiocel BLA under active FDA review; PDUFA target action date of August 22, 2026; labeling discussions expected soon.","Filed suit against Nippon Shinyaku/NS Pharma citing flawed pricing in distribution agreement; seeking rescission and preliminary injunction.","New Chief Commercial Officer with direct DMD experience expected to join in coming weeks; eligible for Priority Review Voucher upon approval."],"urls":{"canonical":"https://secwatch.observer/filing/0001104659-26-059380","json":"https://secwatch.observer/filing/0001104659-26-059380.json","markdown":"https://secwatch.observer/filing/0001104659-26-059380.md","text":"https://secwatch.observer/filing/0001104659-26-059380.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1133869/000110465926059380/0001104659-26-059380-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1133869/000110465926059380/capr-20260512x8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-12T21:29:10.085088+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":[{"claim_id":"6458d503c1b27182f2ecbc91149b76529811c28d","claim":"CAPRICOR THERAPEUTICS, INC. reported financial results for first quarter ended March 31, 2026.","evidence_excerpt":"today announced its financial results for the first quarter ended March 31, 2026","evidence_source":"SEC 8-K Item 2.02","evidence_url":"https://www.sec.gov/Archives/edgar/data/1133869/000110465926059380/0001104659-26-059380-index.htm","confidence":0.9,"family_label":"Earnings Releases","details":[{"label":"Period","value":"first quarter ended March 31, 2026"},{"label":"Result","value":"reported results"}],"fact_type":"earnings_release"}],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}