{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-25-032012","form_type":"8-K","ticker":"RCKT","cik":"0001281895","company_name":"ROCKET PHARMACEUTICALS, INC.","filed_at":"2025-08-20T23:59:59+00:00","discovered_at":"2026-05-14T18:02:43.575560+00:00","generated_at":"2026-05-17T11:06:17.000342+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Rocket Pharmaceuticals: FDA lifts clinical hold on Phase 2 trial of RP-A501 for Danon disease","bullets":["FDA lifted clinical hold in under 3 months; trial resumes with recalibrated dose 3.8x10^13 GC/kg for 3 patients with 4-week intervals.","Revised immunomodulatory regimen: discontinue prophylactic C3 inhibitor, maintain sirolimus/rituximab/steroids, lower eculizumab threshold.","Phase 2 trial is 12-patient single-arm; co-primary endpoint: LAMP2 expression and left ventricular mass reduction; key secondary: troponin change.","Six patients previously treated at 6.7x10^13 GC/kg; three additional at lower dose to be treated sequentially.","Natural history study running concurrently; all patients require 3-month pre-treatment run-in for biomarker assessment."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-25-032012","json":"https://secwatch.observer/filing/0001140361-25-032012.json","markdown":"https://secwatch.observer/filing/0001140361-25-032012.md","text":"https://secwatch.observer/filing/0001140361-25-032012.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1281895/000114036125032012/0001140361-25-032012-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1281895/000114036125032012/ef20054253_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T11:06:17.000342+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"}