{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-26-036563","form_type":"8-K","ticker":"RCKT","cik":"0001281895","company_name":"ROCKET PHARMACEUTICALS, INC.","filed_at":"2026-09-15T11:06:51+00:00","discovered_at":"2026-09-15T11:10:01.017759+00:00","generated_at":"2026-09-15T11:10:07.490286+00:00","sec_items":["7.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Rocket Pharma gets FDA alignment on pivotal Danon trial; 12-patient cohort path clear","bullets":["FDA confirms 12-patient pivotal population for RP-A501; first 3 treated under modified protocol count toward it.","Recalibrated dose 3.8e13 GC/kg; no thrombotic microangiopathy or capillary leak in first 3 patients.","Co-primary endpoints: myocardial LAMP2 expression and 10% reduction in left ventricular mass index at 12 months, supporting potential accelerated approval.","Company expects to complete dosing of remaining 9 patients by mid-2027.","Virtual investor webinar on Danon disease program scheduled for Oct 6, 2026 at 4:30 p.m. ET."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-26-036563","json":"https://secwatch.observer/filing/0001140361-26-036563.json","markdown":"https://secwatch.observer/filing/0001140361-26-036563.md","text":"https://secwatch.observer/filing/0001140361-26-036563.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1281895/000114036126036563/0001140361-26-036563-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1281895/000114036126036563/ef20082010_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-09-15T11:10:07.490286+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"}