Citius Pharmaceuticals’ oncology arm, Citius Oncology, announced the nationwide launch of LYMPHIR (denileukin diftitox‑cxdl) on December 1 2025. LYMPHIR, the company’s first marketed product, received FDA approval on August 7 2024 for relapsed or refractory stage I‑III cutaneous T‑cell lymphoma (CTCL) after at least one prior systemic therapy.
The launch follows a comprehensive pre‑launch strategy that included inventory build‑up and distribution agreements with specialty distributors. LYMPHIR’s entry into the U.S. market taps an addressable market estimated at more than $400 million, positioning Citius to transition from a development‑stage biopharma to a revenue‑generating enterprise.
Clinical data from the pivotal phase 3 trial underpin the launch: an objective response rate of 36.2%, 84 % of evaluable patients experienced a reduction in skin tumor burden, and the median time to response was 1.4 months. These results, combined with the drug’s inclusion in NCCN guidelines and a permanent J‑code (J9161) effective April 1 2025, provide a clear reimbursement pathway and strengthen market access.
Leonard Mazur, Chairman and CEO, emphasized the significance of the launch: “LYMPHIR addresses a clear clinical need in a disease with limited treatment options. It is our first marketed product and a catalyst for shareholder value.” He added that the rapid response time offers “rapid skin relief” for patients suffering from severe itching associated with CTCL.
Financially, the launch follows a Q3 2025 earnings report that showed a net loss of $9.2 million, driven by a decrease in R&D expenses and an increase in G&A expenses. While the company remains pre‑revenue, the launch is expected to become the primary revenue driver and to improve the company’s financial trajectory.
Market reaction to the launch was strong: Citius Oncology’s stock surged 27.7 % on Monday, December 1 2025, reflecting investor confidence in the company’s ability to generate revenue and capture a sizable share of the CTCL market.
The launch marks a pivotal moment for Citius, validating its strategy and providing a foundation for future growth, including potential label expansions and the development of other pipeline assets such as Mino‑Lok.
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