Citius Pharmaceuticals and Citius Oncology Highlight LYMPHIR Commercial Launch Planned for the First Half of 2025

LYMPHIR Launch Preparations - Citius Pharmaceuticals and its subsidiary Citius Oncology are preparing for the commercial launch of LYMPHIR, an immunotherapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL), with a planned launch in the first half of 2025 [1] - Key launch activities include finalizing manufacturing, marketing, reimbursement, and sales efforts, with a focus on U S market penetration and exploring international licensing partnerships [2] - The company has secured commercial supply agreements with leading contract manufacturing organizations (CMOs) and produced the first year launch supply [5] LYMPHIR Product Overview - LYMPHIR is a targeted immune therapy for Stage I-III CTCL after at least one prior systemic therapy, combining the IL-2 receptor binding domain with diphtheria toxin fragments to inhibit protein synthesis and induce cell death [4] - The therapy was approved by the FDA in August 2024 and has exclusive licensing rights in all markets except Japan and certain parts of Asia [6] Market and Disease Context - CTCL is the most common type of cutaneous non-Hodgkin lymphoma, affecting men twice as often as women and typically diagnosed in patients aged 50-60 [7] - The initial market for LYMPHIR is estimated to exceed $400 million, with robust intellectual property protections supporting its competitive positioning [31] Citius Pharmaceuticals and Oncology Overview - Citius Pharmaceuticals owns 92% of Citius Oncology, which focuses on developing and commercializing novel targeted oncology therapies [33] - Citius Pharma's pipeline includes Mino-Lok, an antibiotic lock solution, and CITI-002 (Halo-Lido), a topical formulation for hemorrhoid relief, both of which have completed pivotal trials [32]