Business
Citius Pharmaceuticals, Inc. Reports Fiscal Year 2025 Financial Results and Provides Business Update
Subsidiary, Citius Oncology, launches cancer immunotherapy, LYMPHIR™, in the U.S. in December 2025CRANFORD, N.J., Dec. 23, 2025 /PRNewswire/ -- Citius
About this update from Citius Oncology, Inc.
[{"type":"text","content":"Subsidiary, Citius Oncology, launches cancer immunotherapy, LYMPHIR™, in the U.S. in December 2025CRANFORD, N.J., Dec. 23, 2025 /PRNewswire/ -- Citius Pharmaceuticals, Inc. (\"Citius Pharma\" or the \"Company\") (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today reported business and financial results for the fiscal year ended September 30, 2025.\"2025 was a pivotal year for Citius as we successfully launched LYMPHIR following its FDA approval, marking the first new systemic therapy for cutaneous T-cell lymphoma (CTCL) patients since 2018. This milestone reflects our ability to execute and our commitment to delivering impactful treatments for patients with limited options,\" said Leonard Mazur, Chairman and CEO of Citius Pharma. \"With LYMPHIR commercially available as of December 2025, we are focused on its successful launch and adoption in 2026, with even greater opportunities ahead to drive value for patients and shareholders. We are actively engaging with the FDA to advance Mino-Lok, exploring additional indications and markets for LYMPHIR, and working diligently to strengthen our financial and operational foundation to support sustained growth. We look forward to reporting on our continued progress in the coming months.\"Fiscal Year 2025 Business Highlights and Subsequent DevelopmentsCitius Pharma subsidiary, Citius Oncology (Nasdaq: CTOR), launched LYMPHIR™ (denileukin diftitox-cxdl), a novel IL-2 receptor-directed immunotherapy, in the U.S. in December 2025 for the treatment of adult patients with relapsed or refractory Stage I-III CTCL after at least one prior systemic therapy;Citius Pharma drove commercial preparations for LYMPHIR's launch through its shared management services agreement with Citius Oncology:Executed service agreements with the three leading U.S. pharmaceutical wholesalers to distribute LYMPHIR throughout the U.S.;Secured access to LYMPHIR in 19 international markets through regional distribution partners via named patient programs (NPPs), which allows access to LYMPHIR where permitted by local law without constituting commercial approval outside the U.S.;Ensured production and sufficient supply of LYMPHIR for up to 18 months of estimated commercial demand;Secured inclusion of LYMPHIR in the National Comprehensive...