{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-24-031749","form_type":"8-K","ticker":"RCKT","cik":"0001281895","company_name":"ROCKET PHARMACEUTICALS, INC.","filed_at":"2024-06-28T23:59:59+00:00","discovered_at":"2026-05-14T18:03:17.701062+00:00","generated_at":"2026-06-01T00:27:54.206354+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"confidence":"high","headline":"Rocket Pharma receives FDA Complete Response Letter for KRESLADI BLA; limited CMC info requested","bullets":["FDA issued Complete Response Letter for KRESLADI (marne-cel) BLA; requested limited additional CMC information.","Company met with FDA CBER senior leaders to align on scope of additional CMC info to support approval expeditiously.","Phase 1/2 data: 100% overall survival at 12 months in 9 patients; all endpoints met; no treatment-related serious AEs."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-24-031749","json":"https://secwatch.observer/filing/0001140361-24-031749.json","markdown":"https://secwatch.observer/filing/0001140361-24-031749.md","text":"https://secwatch.observer/filing/0001140361-24-031749.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1281895/000114036124031749/0001140361-24-031749-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1281895/000114036124031749/ef20031912_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-01T00:27:54.206354+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"}