{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-24-023483","form_type":"8-K","ticker":"CTXR","cik":"0001506251","company_name":"Citius Pharmaceuticals, Inc.","filed_at":"2024-03-18T23:59:59+00:00","discovered_at":"2026-05-14T18:03:24.377529+00:00","generated_at":"2026-06-04T15:03:56.530525+00:00","sec_items":["8.01","9.01"],"event_type":"regulatory","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"confidence":"high","headline":"Citius Pharma: FDA accepts BLA resubmission for LYMPHIR (CTCL); PDUFA Aug 13, 2024","bullets":["FDA accepted BLA resubmission for LYMPHIR (denileukin diftitox) to treat relapsed/refractory cutaneous T-cell lymphoma.","PDUFA target action date set for August 13, 2024.","Resubmission addresses July 2023 CRL; no safety or efficacy issues cited, no additional trials required.","BLA supported by pivotal Phase 3 study (NCT01871727)."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-24-023483","json":"https://secwatch.observer/filing/0001213900-24-023483.json","markdown":"https://secwatch.observer/filing/0001213900-24-023483.md","text":"https://secwatch.observer/filing/0001213900-24-023483.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1506251/000121390024023483/0001213900-24-023483-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1506251/000121390024023483/ea0202010-8k_citius.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-06-04T15:03:56.530525+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"}