Citius Oncology Expands International Distribution of LYMPHIR™ to European Union Through Exclusive Agreement with Uniphar
Third international distribution agreement further advances global access strategy with major markets in Europe
CRANFORD, N.J., Feb. 11, 2026 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology") (NASDAQ:CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (NASDAQ:CTXR), today announced that it has entered into an exclusive distribution agreement with Uniphar ("Uniphar"), a leading international healthcare services company, to support access to LYMPHIR™ (denileukin diftitox-cxdl) outside the United States. This agreement represents Citius Oncology's third international distribution partnership and further advances the Company's strategy to expand global access to LYMPHIR through established regional partners.
Under the terms of the agreement, Uniphar will serve as the exclusive distribution partner for LYMPHIR in designated international territories in Western and Eastern Europe through country-specific managed access programs, where permitted by local law. Uniphar will oversee market access and distribution activities in selected territories. Citius Oncology will supply finished product and provide ongoing support in accordance with the agreement. LYMPHIR is not approved for commercial use outside the United States and, where permitted by local law, will be provided in the territories covered by this agreement solely through country-specific managed access programs, which do not constitute marketing authorization or a commercial launch.
"This agreement with Uniphar builds on the momentum of our international expansion efforts and reflects our commitment to partnering with experienced organizations that have deep regional expertise and proven execution capabilities," said Leonard Mazur, Chairman and Chief Executive Officer of Citius Oncology and Citius Pharmaceuticals. "As our third international distribution agreement, this partnership further strengthens our ability to responsibly expand access to LYMPHIR for patients with limited treatment options, while continuing to lay the groundwork for long-term global growth."
"We are thrilled to partner with Citius Oncology to expand access to LYMPHIR across Europe. Uniphar is committed to connecting patients with innovative therapies, and this agreement strengthens our ability to support clinicians and improve outcomes for those living with or relapsed or refractory cutaneous T-cell lymphoma (CTCL)," stated Brian O'Shaughnessy, Chief Commercial Officer of Uniphar.
This agreement follows Citius Oncology's previously announced international distribution partnerships, including exclusive arrangements in Southern Europe, the Balkans, Turkey, and the Middle East. Together, these collaborations underscore the Company's disciplined approach to international expansion through trusted partners with local expertise and established infrastructure.
About LYMPHIR™ (denileukin diftitox-cxdl)
LYMPHIR is a targeted immune therapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated for use in Stage I-III disease after at least one prior systemic therapy. It is a recombinant fusion protein that combines the IL-2 receptor binding domain with diphtheria toxin (DT) fragments. The agent specifically binds to IL-2 receptors on the cell surface, causing diphtheria toxin fragments that have entered cells to inhibit protein synthesis. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors.
In 2021, denileukin diftitox received regulatory approval in Japan for the treatment of relapsed or refractory CTCL and peripheral T-cell lymphoma (PTCL). Subsequently, in 2021, Citius acquired an exclusive license with rights to develop and commercialize denileukin diftitox in all markets except for India, Japan and certain parts of Asia. LYMPHIR (denileukin diftitox-cxdl) was approved by the FDA and subsequently launched in the U.S. in December 2025.
About Cutaneous T-cell Lymphoma
Cutaneous T-cell lymphoma is a type of cutaneous non-Hodgkin lymphoma (NHL) that comes in a variety of forms and is the most common type of cutaneous lymphoma. In CTCL, T-cells, a type of lymphocyte that plays a role in the immune system, become cancerous and develop into skin lesions, leading to a decrease in the quality of life of patients with this disease due to severe pain and pruritus. Mycosis Fungoides (MF) and Sézary Syndrome (SS) comprise the majority of CTCL cases. Depending on the type of CTCL, the disease may progress slowly and can take anywhere from several years to upwards of ten to potentially reach tumor stage. However, once the disease reaches this stage, the cancer is highly malignant and can spread to the lymph nodes and internal organs, resulting in a poor prognosis. Given the duration of the disease, patients typically cycle through multiple agents to control disease progression. CTCL affects men twice as often as women and is typically first diagnosed in patients between the ages of 50 and 60 years of age. Other than allogeneic stem cell transplantation, for which only a small fraction of patients qualify, there is currently no curative therapy for advanced CTCL.
About Uniphar Plc.
Headquartered in Dublin, Ireland, Uniphar is an international diversified healthcare services business servicing the requirements of more than 200 multinational pharmaceutical and medical technology manufacturers across three divisions - Uniphar Pharma, Uniphar Medtech and Uniphar Supply Chain & Retail. The Group is active in Europe, North America, APAC and MENA.
Uniphar Pharma integrates Development, Clinical, Access, Medical, Commercial, Distribution and Global Sourcing to support the full product lifecycle – from early-stage research through to commercialization and beyond. Uniphar's unified platform spans regulatory strategy, clinical trial support, medical affairs, market access, patient engagement, commercial services, distribution and supply chain.
Operating across 180 countries with a global team of 3,500+, Uniphar bridges manufacturers, healthcare providers, and patients — accelerating access to innovative therapies, improving patient outcomes, and delivering value across the healthcare ecosystem.
For more information, please visit www.uniphar.com
About Citius Oncology, Inc.
Citius Oncology, Inc. (NASDAQ:CTOR) is a platform to develop and commercialize novel targeted oncology therapies. In December 2025, Citius Oncology launched LYMPHIR, approved by the FDA for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Management estimates the initial market for LYMPHIR currently exceeds $400 million, is growing, and is underserved by existing therapies. Robust intellectual property protections that span orphan drug designation, complex technology, trade secrets and pending patents for immuno-oncology use as a combination therapy with checkpoint inhibitors would further support Citius Oncology's competitive positioning. For more information, please visit www.citiusonc.com.
About Citius Pharmaceuticals, Inc.
Citius Pharmaceuticals, Inc. (NASDAQ:CTXR) is a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. Citius Pharma owns 75% of Citius Oncology. In December 2025, Citius Oncology launched LYMPHIR, a targeted immunotherapy for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy. Citius Pharma's late-stage pipeline also includes Mino-Lok®, a catheter lock solution to salvage catheters in patients with catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for the relief of hemorrhoids. A pivotal Phase 3 trial for Mino-Lok and a Phase 2b trial for Halo-Lido were completed in 2023. Mino-Lok met primary and secondary endpoints of its Phase 3 trial. Citius Pharma is actively engaged with the FDA to outline next steps for both programs. For more information, please visit www.citiuspharma.com.
Forward-Looking Statements
This press release may contain "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements are made based on our expectations and beliefs concerning future events impacting Citius Oncology. You can identify these statements by the fact that they use words such as "will," "anticipate," "estimate," "expect," "plan," "should," and "may" and other words and terms of similar meaning or use of future dates. Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated, and, unless noted otherwise, that apply to Citius Oncology, are: our need for substantial additional funds and our ability to raise additional money to fund our operations for at least the next 12 months as a going concern; our ability to successfully commercialize LYMPHIR and establish a sustainable revenue stream; the estimated markets for LYMPHIR and our product candidates and the acceptance thereof by any market; our ability to secure strategic partnerships and expand international access to LYMPHIR; our ability to maintain Nasdaq's continued listing standards; our ability to use the latest technology to support our commercialization efforts; physician and patient acceptance of LYMPHIR in a competitive treatment landscape; our reliance on third-party logistics providers, distributors, and specialty pharmacies to support commercial operations; our ability to educate providers and payers, secure adequate reimbursement, and maintain uninterrupted product supply; post-marketing requirements and ongoing regulatory compliance related to LYMPHIR; the ability of LYMPHIR and our product candidates to impact the quality of life of our target patient populations; risks relating to the results of research and development activities, including those from our existing and any new pipeline assets; our ability to procure cGMP commercial-scale supply; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; market and other conditions; risks related to our growth strategy; patent and intellectual property matters; our ability to identify, acquire, close and integrate product candidates and companies successfully and on a timely basis; government regulation; as well as other risks described in our Securities and Exchange Commission ("SEC") filings. These risks have been and may be further impacted by any future public health risks. Accordingly, these forward-looking statements do not constitute guarantees of future performance, and you are cautioned not to place undue reliance on these forward-looking statements. Risks regarding our business are described in detail in our SEC filings which are available on the SEC's website at www.sec.gov, including in Citius Oncology's Annual Report on Form 10-K for the year ended September 30, 2025, filed with the SEC on December 23, 2025, as updated by our subsequent filings with the SEC. These forward-looking statements speak only as of the date hereof, and we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.
Investor Contact:
Ilanit Allen
ir@citiuspharma.com
908-967-6677 x113
Media Contact:
STiR-communications
Greg Salsburg
Greg@STiR-communications.com
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SOURCE Citius Oncology, Inc.
