{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-25-020409","form_type":"8-K","ticker":"RCKT","cik":"0001281895","company_name":"ROCKET PHARMACEUTICALS, INC.","filed_at":"2025-05-27T23:59:59+00:00","discovered_at":"2026-05-14T18:02:47.830044+00:00","generated_at":"2026-05-20T10:17:42.369966+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.9,"calibrated_materiality_score":0.9,"confidence":"high","headline":"Rocket Pharma announces FDA clinical hold on Phase 2 Danon gene therapy trial after patient death","bullets":["Patient in Phase 2 trial of RP-A501 experienced SAE (capillary leak syndrome) and later died due to acute systemic infection.","FDA placed clinical hold on May 23, 2025; company had voluntarily paused dosing earlier.","Root cause analysis focusing on novel immune suppression agent added to pre-treatment regimen for complement activation.","Company unable to provide guidance on trial completion timing.","Cash $318.2M as of March 31, 2025; expects to fund operations into 2027 with reduced spend."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-25-020409","json":"https://secwatch.observer/filing/0001140361-25-020409.json","markdown":"https://secwatch.observer/filing/0001140361-25-020409.md","text":"https://secwatch.observer/filing/0001140361-25-020409.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1281895/000114036125020409/0001140361-25-020409-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1281895/000114036125020409/ef20049685_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-20T10:17:42.369966+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"}