Citius Oncology, the oncology arm of Citius Pharmaceuticals, has entered into an exclusive distribution agreement with Er‑Kim İlaç Sanayi ve Ticaret A.Ş. to supply its FDA‑approved drug LYMPHIR (denileukin diftitox‑cxdl) in Turkey and the Gulf Cooperation Council (GCC) countries—Bahrain, Qatar, Oman, Kuwait, Saudi Arabia and the United Arab Emirates.
The partnership gives Citius Oncology a dedicated sales, marketing and reimbursement network in each territory, allowing LYMPHIR to be marketed and reimbursed under local regulations. The deal expands the company’s international strategy to 19 markets outside the United States, adding the Turkish and GCC territories to the 13 European and Balkan countries that were previously served through named‑patient programs.
LYMPHIR received FDA approval on August 7 2024 for relapsed or refractory stage I‑III cutaneous T‑cell lymphoma after at least one prior systemic therapy. The drug entered the U.S. commercial market on December 1 2025, positioning it to capture a projected $400 million+ U.S. market over the next few years. The new distribution agreement extends that potential to high‑need oncology markets in the Middle East, where CTCL incidence is rising and access to approved therapies is limited.
Citius Pharmaceuticals reported a net loss of $9.2 million, or ($0.80) per share, for the third quarter of fiscal 2025 (ended June 30 2025), a modest improvement from a $10.6 million loss in the same period a year earlier. Revenue for the quarter was $0, missing analyst estimates of $1.92 million. The company’s cash and cash equivalents stood at $6.1 million as of June 30 2025, and it has raised $12.5 million in gross financing during the quarter, underscoring the need for continued capital to support LYMPHIR’s launch and commercialization.
Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharmaceuticals, said the partnership “represents a significant milestone in our global expansion strategy.” He added that Er‑Kim’s “deep industry experience and strong track record of commercializing oncology therapies in complex international markets” will help LYMPHIR “reach patients who need it” and accelerate the company’s transition from a development‑stage entity to a revenue‑generating business.
The agreement positions LYMPHIR for broader market access and potential revenue growth in high‑need oncology markets, aligning with Citius Oncology’s strategy to move beyond the U.S. and capitalize on the growing global demand for CTCL treatments. By securing a partner with established regional expertise, the company can leverage local reimbursement pathways and market knowledge, reducing time to market and increasing the likelihood of successful uptake in the GCC and Turkey.
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