Citius Oncology launches LYMPHIR for CTCL; first marketed product

Citius Pharmaceuticals, Inc.

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.

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