---
schema_version: "secwatch.filing_event.v1"
accession: "0001213900-25-116760"
form_type: "8-K"
ticker: "CTXR"
cik: "0001506251"
company_name: "Citius Pharmaceuticals, Inc."
filed_at: "2025-12-01T23:59:59+00:00"
generated_at: "2026-05-16T15:52:38.570416+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# Citius Oncology launches LYMPHIR for CTCL; first marketed product

## Summary
- LYMPHIR (denileukin diftitox-cxdl) now commercially available in U.S. for relapsed/refractory Stage I–III CTCL after prior systemic therapy.
- Phase 3 pivotal study: ORR 36.2%, 84% skin tumor burden reduction, median response time 1.4 months, no cumulative toxicity.
- Estimated U.S. market >$400M; permanent J-code (J9161) effective April 1, 2025; NCCN Category 2A recommendation.
- International expansion via Integris Pharma distribution agreement for Southern Europe and Balkan countries.
- Patient assistance program (Citius Advantage) and HCP portal (lymphirhcp.com) launched to support access.

## SEC filing metadata
- accession: 0001213900-25-116760
- form_type: 8-K
- ticker: CTXR
- cik: 0001506251
- company_name: Citius Pharmaceuticals, Inc.
- filed_at: 2025-12-01T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 7.01, 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1506251/000121390025116760/0001213900-25-116760-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1506251/000121390025116760/ea0267562-8k_citius.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001213900-25-116760
- JSON: https://secwatch.observer/filing/0001213900-25-116760.json
- Plain text: https://secwatch.observer/filing/0001213900-25-116760.txt

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