{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-25-038030","form_type":"8-K","ticker":"RCKT","cik":"0001281895","company_name":"ROCKET PHARMACEUTICALS, INC.","filed_at":"2025-10-14T23:59:59+00:00","discovered_at":"2026-05-14T18:02:39.023451+00:00","generated_at":"2026-05-17T03:51:17.859248+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"confidence":"high","headline":"Rocket Pharma: FDA accepts BLA resubmission for KRESLADI gene therapy; PDUFA March 28, 2026","bullets":["FDA accepted BLA resubmission for KRESLADI (marne-cel) for severe LAD-I; PDUFA target date March 28, 2026.","Phase 1/2 study showed 100% overall survival at 12 months; all endpoints met; well tolerated with no treatment-related SAEs.","Company eligible for Rare Pediatric Disease Priority Review Voucher if KRESLADI is approved.","Severe LAD-I is near-uniformly fatal in childhood; only current treatment is bone marrow transplant with substantial morbidity."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-25-038030","json":"https://secwatch.observer/filing/0001140361-25-038030.json","markdown":"https://secwatch.observer/filing/0001140361-25-038030.md","text":"https://secwatch.observer/filing/0001140361-25-038030.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1281895/000114036125038030/0001140361-25-038030-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1281895/000114036125038030/ef20057000_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-17T03:51:17.859248+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"}