{"schema_version":"secwatch.filing_event.v1","accession":"0001213900-24-102265","form_type":"8-K","ticker":"CTXR","cik":"0001506251","company_name":"Citius Pharmaceuticals, Inc.","filed_at":"2024-11-25T23:59:59+00:00","discovered_at":"2026-05-14T18:03:08.623830+00:00","generated_at":"2026-05-29T18:49:19.298339+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 Pharmaceuticals Reports Productive FDA Type C Meeting for Mino-Lok Phase 3 Program","bullets":["Citius Pharma held a constructive in-person Type C meeting with the FDA on November 25, 2024, regarding its Phase 3 Mino-Lok trial for catheter-related bloodstream infections.","The FDA provided clear, actionable guidance on clinical efficacy and safety data, supporting a pathway to a future New Drug Application (NDA) submission.","Chairman and CEO Leonard Mazur stated the Agency's comprehensive feedback provides a strong framework for completing remaining steps toward an NDA.","Mino-Lok, if approved, could reduce healthcare costs and improve outcomes by salvaging central venous catheters instead of removing them."],"urls":{"canonical":"https://secwatch.observer/filing/0001213900-24-102265","json":"https://secwatch.observer/filing/0001213900-24-102265.json","markdown":"https://secwatch.observer/filing/0001213900-24-102265.md","text":"https://secwatch.observer/filing/0001213900-24-102265.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1506251/000121390024102265/0001213900-24-102265-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1506251/000121390024102265/ea0222478-8k_citius.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-05-29T18:49:19.298339+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"}