{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-24-066357","form_type":"8-K","ticker":"CTXR","cik":"0001506251","company_name":"Citius Pharmaceuticals, Inc.","filed_at":"2024-08-08T23:59:59+00:00","discovered_at":"2026-05-14T18:03:13.292235+00:00","generated_at":"2026-05-31T10:52:09.469603+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.95,"calibrated_materiality_score":0.95,"confidence":"high","headline":"Citius Pharma receives FDA approval for LYMPHIR (denileukin diftitox-cxdl) in r/r CTCL","bullets":["Phase 3 study showed 36.2% ORR, 8.7% complete response, median time to response 1.41 months.","First FDA-approved product for Citius; launch expected within next five months.","Boxed warning for capillary leak syndrome; postmarketing requirement to assess visual impairment risk.","Only systemic therapy targeting IL-2 receptor on malignant T-cells and Tregs for CTCL.","US market for r/r CTCL estimated at $300–$400 million; no cumulative toxicity observed."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-24-066357","json":"https://secwatch.observer/filing/0001213900-24-066357.json","markdown":"https://secwatch.observer/filing/0001213900-24-066357.md","text":"https://secwatch.observer/filing/0001213900-24-066357.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1506251/000121390024066357/0001213900-24-066357-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1506251/000121390024066357/ea0210874-8k_citius.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-31T10:52:09.469603+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"}