{"schema_version":"secwatch.filing_event.v1","accession":"0001628280-25-003753","form_type":"8-K","ticker":"CPIX","cik":"0001087294","company_name":"CUMBERLAND PHARMACEUTICALS INC","filed_at":"2025-02-04T23:59:59+00:00","discovered_at":"2026-05-14T18:03:02.899107+00:00","generated_at":"2026-05-27T03:18:48.598537+00:00","sec_items":["8.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Cumberland Pharma Phase 2 ifetroban trial meets primary endpoint in DMD heart disease","bullets":["High-dose ifetroban (300mg/day) produced 3.3% LVEF improvement vs placebo decline of 1.5%, net 4.8% benefit.","Comparison with propensity-matched natural history controls showed 5.4% overall LVEF improvement in high-dose group.","Both doses were well-tolerated; no serious drug-related events reported among 41 enrolled DMD patients.","Ifetroban holds FDA Orphan Drug and Rare Pediatric Disease Designations; first Phase 2 study for DMD heart disease.","Company plans end of Phase 2 FDA meeting to discuss development path; potential first therapy for DMD cardiomyopathy."],"urls":{"canonical":"https://secwatch.observer/filing/0001628280-25-003753","json":"https://secwatch.observer/filing/0001628280-25-003753.json","markdown":"https://secwatch.observer/filing/0001628280-25-003753.md","text":"https://secwatch.observer/filing/0001628280-25-003753.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1087294/000162828025003753/0001628280-25-003753-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1087294/000162828025003753/cpix-20250204.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-27T03:18:48.598537+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"}