---
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"
generated_at: "2026-05-31T10:52:09.469603+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.95
calibrated_materiality_score: 0.95
confidence: "high"
source: SEC EDGAR
---

# Citius Pharma receives FDA approval for LYMPHIR (denileukin diftitox-cxdl) in r/r CTCL

## Summary
- 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.

## SEC filing metadata
- 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
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.95
- calibrated_materiality_score: 0.95
- confidence: high
- sec_items: 8.01, 9.01
- 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

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-24-066357
- JSON: https://secwatch.observer/filing/0001213900-24-066357.json
- Plain text: https://secwatch.observer/filing/0001213900-24-066357.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.