{"schema_version":"secwatch.filing_event.v1","accession":"0001140361-23-043687","form_type":"8-K","ticker":"RCKT","cik":"0001281895","company_name":"ROCKET PHARMACEUTICALS, INC.","filed_at":"2023-09-12T23:59:59+00:00","discovered_at":"2026-05-14T18:03:33.424028+00:00","generated_at":"2026-06-10T19:59:26.196706+00:00","sec_items":["7.01","8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Rocket Pharma reaches FDA alignment on Phase 2 pivotal trial for RP-A501 in Danon Disease","bullets":["FDA agreed to single-arm, open-label trial with 12 patients, natural history comparator, and co-primary endpoint of LAMP2 expression and LV mass at 12 months for accelerated approval.","In-house cGMP manufacturing completed with sufficient drug product to supply the pivotal study; potency assays qualified per FDA guidance.","ICD-10 code secured from CMS for LAMP2 deficiency; CTA/IMPD filing for EU initiation expected by end of Q3 2023.","RP-A501 is a one-time infusion targeting a uniformly fatal cardiomyopathy with no approved therapies; affects 15,000–30,000 in US and Europe."],"urls":{"canonical":"https://secwatch.observer/filing/0001140361-23-043687","json":"https://secwatch.observer/filing/0001140361-23-043687.json","markdown":"https://secwatch.observer/filing/0001140361-23-043687.md","text":"https://secwatch.observer/filing/0001140361-23-043687.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1281895/000114036123043687/0001140361-23-043687-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1281895/000114036123043687/ny20010507x2_8k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-10T19:59:26.196706+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"}