Citius Pharmaceuticals launches cancer drug LYMPHIR following FDA approval

Citius Pharmaceuticals Inc. (NASDAQ: CTXR) reported fiscal year 2025 financial results, highlighting the launch of LYMPHIR through its subsidiary Citius Oncology Inc. (NASDAQ: CTOR) in December 2025.

LYMPHIR, a novel IL-2 receptor-directed immunotherapy, received FDA approval for treating adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma after at least one prior systemic therapy. The drug represents the first new systemic therapy for this patient population since 2018.

The company secured distribution agreements with three leading U.S. pharmaceutical wholesalers and obtained access to LYMPHIR in 19 international markets through named patient programs. LYMPHIR received inclusion in National Comprehensive Cancer Network guidelines with a Category 2A recommendation and a unique HCPCS J-code for coverage and reimbursement purposes.

For fiscal year 2025 ended September 30, Citius Pharmaceuticals reported no revenues. Research and development expenses totaled $9.2 million compared to $11.9 million in the prior year. General and administrative expenses were $18.5 million versus $18.2 million in fiscal 2024. The company recorded a net loss of $39.7 million, or $3.38 per share, compared to a net loss of $40.2 million, or $5.97 per share, in the previous year.

Cash and cash equivalents stood at $4.3 million as of September 30, 2025. The company raised approximately $61 million in gross proceeds from capital raises, with Citius Pharmaceuticals securing $25 million and Citius Oncology obtaining $36 million during and after the fiscal year end.

Citius Pharmaceuticals owns approximately 78% of Citius Oncology. The company continues engagement with the FDA regarding paths forward for its other pipeline products, Mino-Lok and Halo-Lido.

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