Citius Oncology Establishes International Access to LYMPHIR™ via Named Patient Programs in Southern Europe

Rhea-AI Summary

Citius Oncology (Nasdaq: CTOR) announced on October 7, 2025 that it is expanding international access to LYMPHIR™ (denileukin diftitox-cxdl) via country-specific Named Patient Programs (NPPs) in Europe, South America and the Middle East.

The company signed an exclusive distribution agreement with Integris Pharma S.A., headquartered in Athens, to cover Greece, Cyprus, Malta, Bulgaria, Romania, Croatia, Serbia, Albania, Bosnia Herzegovina, Kosovo, Montenegro and North Macedonia. NPPs provide early patient access prior to full marketing authorization and do not constitute commercial approval outside the U.S.

Positive

• Exclusive distribution agreement signed with Integris Pharma
• Integris coverage of 12 Southern Europe and Balkan countries
• NPP access aims to accelerate physician real-world experience with LYMPHIR
• Company pursuing NPPs across Europe, South America, Middle East

Negative

• Named Patient Programs do not equal marketing authorization or revenue
• International access depends on country-specific legal permissions
• Commercial launch outside U.S. remains contingent on future approvals

Insights

Market Access Analyst

Exclusive Integris partnership and multi‑region Named Patient Programs expand early access and regional footprint for LYMPHIR.

Citius Oncology establishes an exclusive distribution agreement with Integris Pharma S.A. covering Greece, Cyprus, Malta, Bulgaria, Romania, Croatia, Serbia, Albania, Bosnia Herzegovina, Kosovo, Montenegro and North Macedonia, and is pursuing NPPs in Europe, South America and the Middle East.

The business mechanism uses country-specific Named Patient Programs to supply eligible patients before full local marketing authorization, which preserves future commercial launch rights while generating physician exposure and real‑world use.

Watch near-term execution milestones: partner onboarding and pharmacovigilance setup in the named countries, physician requests under NPPs, and any regulatory constraints that limit supply or eligibility; these items should show traction over the next 6–18 months.

Clinical Access Strategist

NPP rollout creates clinical touchpoints and experience with LYMPHIR without implying regulatory approval outside the U.S.

Named Patient Programs permit physicians to request LYMPHIR for individual patients when no adequate approved alternatives exist, enabling early clinical exposure in routine practice while preserving formal approval processes.

Dependencies and risks remain clear: NPPs do not equal marketing authorization and operate only where local law permits, so scale and data generation will vary by country and by physician uptake.

Concrete items to monitor include the volume of NPP requests, reporting and safety data flow from Integris, and progress toward formal market authorizations; meaningful signals should appear within 2026 and into 2027.

Exclusive relationship through Named Patient Programs establishes footprint in Greece, Cyprus and additional Balkan countries

CRANFORD, N.J., Oct. 7, 2025 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology" or the "Company") (Nasdaq: CTOR), a specialty biopharmaceutical company focused on the development and commercialization of novel targeted oncology therapies today announced it is actively engaging with regional distribution partners to make LYMPHIR™ (denileukin diftitox-cxdl) available to eligible patients through country-specific Named Patient Programs (NPPs) in Europe, South America and the Middle East. As part of its NPP strategy, Citius has entered into an exclusive distribution agreement with Integris Pharma S.A., headquartered in Athens, Greece. The partnership covers Greece, Cyprus, Malta, Bulgaria, Romania, Croatia, Serbia, Albania, Bosnia Herzegovina, Kosovo, Montenegro and North Macedonia.

Named Patient Programs, also known as early access programs, are formally recognized pathways designed to give patients earlier access to promising new medicines in advance of full marketing authorization and commercial availability in markets outside the United States. Under these programs, a treating physician may request a therapy on behalf of an individual patient when no adequate approved alternatives exist. In doing so, NPPs bridge a critical gap between the completion of clinical trials in each region and broad market introduction, ensuring that patients with serious illnesses are not left waiting for life-extending innovations. These programs provide access, where permitted by local law, and do not constitute commercial approval of LYMPHIR outside the United States.

"As we prepare to launch LYMPHIR in the U.S., expanding access to international markets through Named Patient Programs is both a patient-driven mission and a strategic opportunity for Citius Oncology. These programs allow us to serve patients who urgently need new treatment options, while also giving physicians valuable firsthand experience with LYMPHIR. Our recently signed exclusive distribution agreement with Integris Pharma S.A. further strengthens this effort, establishing a trusted partner to help us bring LYMPHIR to patients across Southern Europe and the Balkans. By accessing NPP pathways outside the U.S., we believe we can accelerate awareness, strengthen clinical adoption, and build relationships with leading treatment centers across these regions, supporting our long-term strategy of establishing LYMPHIR as a global treatment standard," said Leonard Mazur, Chairman and Chief Executive Officer of Citius Oncology and Citius Pharmaceuticals.

For individuals living outside the U.S. with serious and difficult-to-treat conditions like cutaneous T-cell lymphoma (CTCL), NPPs can make a meaningful difference by enabling earlier access to innovative medicines. These programs also allow physicians to gain real-world experience with LYMPHIR in routine clinical practice, complementing data from controlled studies and helping inform treatment decisions for future patients.

Integris Pharma is a privately-owned specialty pharmaceutical company with deep expertise in oncology, hematology, and rare diseases. As a trusted partner to global biopharmaceutical innovators, Integris Pharma maintains a robust presence in Greece and Southern Europe, offering end-to-end support in these markets. This includes regulatory and market access management, pricing and reimbursement navigation, importation, storage and distribution, medical detailing, and pharmacovigilance and quality assurance. The company also delivers patient-centric programs that support awareness, diagnosis, and treatment journeys. With strong relationships across hospitals, clinics, and regulators, Integris Pharma provides the infrastructure, compliance, and regional know-how to ensure innovative therapies reach patients quickly and effectively, making it an ideal distribution partner in Southern Europe.

Citius is in active discussions with multiple prospective distribution partners across several European Union member states, in South America, and in select Middle Eastern territories. These efforts reflect the Company's commitment to ensuring patient access wherever possible and underscore the broader strategic importance of positioning LYMPHIR for growth in key markets outside the United States.

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 of tumor cells and immunosuppressive regulatory T-cells (T-regs) and is internalized. After uptake into the cell, the DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. This action leads to direct tumoricidal effects as well as a transient depletion of T-regs to enhance overall antitumor activity.

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 Japan and certain parts of Asia. LYMPHIR (denileukin diftitox-cxdl) was approved by the FDA in August 2024.

LYMPHIR (denileukin diftitox-cxdl) is approved by the U.S. Food and Drug Administration for the treatment of adult patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. LYMPHIR has not been approved for commercial use outside of the United States. Access to LYMPHIR in countries where it is not approved will only be possible through country-specific Named Patient Programs, where permitted by local law and subject to physician request. Such access is provided on an unlicensed basis and does not constitute a commercial launch of LYMPHIR in those territories.

Please read Important Safety Information and full Prescribing Information, including Boxed WARNING, for LYMPHIR. 

About Cutaneous T-cell Lymphoma (CTCL)

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 Citius Oncology, Inc.

Citius Oncology specialty is a biopharmaceutical company focused on developing and commercializing novel targeted oncology therapies. In August 2024, its primary asset, LYMPHIR, was approved by the FDA for the treatment of adults with relapsed or refractory 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. Citius Oncology is a publicly traded subsidiary of Citius Pharmaceuticals. For more information, please visit www.citiusonc.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 ability to secure distribution agreements for LYMPHIR under the Named Patient Program pathways outside of the United States; our need for substantial additional funds and our ability to raise additional money to fund our operations beyond September 2025 and for at least the next 12 months as a going concern; our ability to commercialize LYMPHIR, including covering the costs of licensing payments, product manufacturing and other third-party goods and services, and any of our other product candidates that may be approved by the FDA; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; the estimated markets for our product candidates and the acceptance thereof by any market; our ability to maintain compliance with Nasdaq's continued listing standards; the ability of our product candidates to impact the quality of life of our target patient populations; our dependence on third-party suppliers; our ability to procure cGMP commercial-scale supply; risks related to research using our assets but conducted by third parties; uncertainties relating to preclinical and clinical testing; market, economic 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; competition; 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, 2024, filed with the SEC on December 27, 2024, as amended on January 27, 2025, Citius Oncology's Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the SEC on August 12, 2025, and 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.

FAQ

What did Citius Oncology (CTOR) announce on October 7, 2025 about LYMPHIR international access?

Citius announced expansion of LYMPHIR access via country-specific Named Patient Programs and an exclusive distribution deal with Integris Pharma covering 12 Southern European and Balkan countries.

Which countries does the Integris Pharma agreement cover for LYMPHIR distribution?

The agreement covers Greece, Cyprus, Malta, Bulgaria, Romania, Croatia, Serbia, Albania, Bosnia Herzegovina, Kosovo, Montenegro and North Macedonia.

Does Named Patient Program (NPP) access for LYMPHIR mean commercial approval in Europe for CTOR?

No. NPPs provide early patient access where permitted by local law and do not constitute marketing authorization or commercial approval outside the U.S.

How will CTOR's NPP strategy affect physician adoption of LYMPHIR?

NPPs allow physicians to gain real-world experience with LYMPHIR in routine practice, which Citius says may accelerate awareness and clinical adoption.

Is Citius pursuing additional international partnerships for LYMPHIR beyond Integris?

Yes. Citius stated it is in active discussions with multiple prospective distribution partners across EU member states, South America, and select Middle Eastern territories.