Partnership expands get admission to to LYMPHIR for sufferers with cutaneous T-cell lymphoma throughout Turkey, Bahrain, Qatar, Oman, Kuwait, Saudi Arabia, and the UAE
LYMPHIR global availability extends to 19 markets outdoor the U.S.
The settlement expands Citius Oncology’s global solution to a complete of nineteen markets outdoor the U.S. leveraging Named Affected person Systems. Those techniques supply get admission to, the place accredited via native regulation, and don’t represent advertisement approval of LYMPHIR outdoor america. In October 2025, Citius Oncology introduced get admission to to LYMPHIR in Greece, Cyprus, Malta, Bulgaria, Romania, Croatia, Serbia, Albania, Bosnia Herzegovina, Kosovo, Montenegro and North Macedonia.
“This agreement represents a significant milestone in our global expansion strategy,” mentioned Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Prescription drugs. “Er-Kim has deep industry experience and a strong track record of providing access to oncology therapies in complex international markets. Their local expertise and regulatory capabilities make them an ideal partner as we work to expand access to LYMPHIR in support of patients and providers across Turkey and the GCC.”
Er-Kim might be chargeable for gross sales, advertising and marketing and repayment actions, underneath acceptable regulations, in every territory. Citius Oncology will provide completed product and fortify Er-Kim’s efforts as a part of the settlement.
This partnership underscores Citius Oncology’s ongoing dedication to develop get admission to to leading edge oncology remedies thru strategic collaborations with skilled international companions.
About LYMPHIR™ (denileukin diftitox-cxdl)
LYMPHIR is a centered immune remedy for relapsed or refractory cutaneous T-cell lymphoma (CTCL) indicated to be used in Degree I-III illness after a minimum of one prior systemic remedy. This is a recombinant fusion protein that mixes the IL-2 receptor binding area with diphtheria toxin (DT) fragments. The agent in particular binds to IL-2 receptors at the cellular floor, inflicting diphtheria toxin fragments that experience entered cells to inhibit protein synthesis. After uptake into the cellular, the DT fragment is cleaved and the loose DT fragments inhibit protein synthesis, leading to cellular dying. Denileukin diftitox-cxdl demonstrated the power to dissipate immunosuppressive regulatory T lymphocytes (Tregs) and antitumor job thru an instantaneous cytocidal motion on IL-2R-expressing tumors.
In 2021, denileukin diftitox gained regulatory approval in Japan for the remedy of relapsed or refractory CTCL and peripheral T-cell lymphoma (PTCL). Therefore, in 2021, Citius bought an unique license with rights to increase and commercialize denileukin diftitox in all markets except for for India, Japan and likely portions of Asia. LYMPHIR (denileukin diftitox-cxdl) was once licensed via the FDA and due to this fact introduced within the U.S. in December 2025.
About Cutaneous T-cell Lymphoma
Cutaneous T-cell lymphoma is a kind of cutaneous non-Hodgkin lymphoma (NHL) that is available in numerous bureaucracy and is the most typical form of cutaneous lymphoma. In CTCL, T-cells, a kind of lymphocyte that performs a task within the immune gadget, turn into cancerous and transform pores and skin lesions, resulting in a lower within the high quality of lifetime of sufferers with this illness because of critical ache and pruritus. Mycosis Fungoides (MF) and Sézary Syndrome (SS) contain the vast majority of CTCL circumstances. Relying on the kind of CTCL, the illness might growth slowly and will take anyplace from a number of years to upwards of ten to probably succeed in tumor degree. Alternatively, as soon as the illness reaches this degree, the most cancers is very malignant and will unfold to the lymph nodes and inner organs, leading to a deficient analysis. Given the period of the illness, sufferers generally cycle thru more than one brokers to regulate illness development. CTCL impacts males two times as regularly as ladies and is generally first recognized in sufferers between the ages of fifty and 60 years of age. Rather than allogeneic stem cellular transplantation, for which just a small fraction of sufferers qualify, there may be lately no healing remedy for complicated CTCL.
About Citius Oncology, Inc.
Citius Oncology, Inc. (Nasdaq: CTOR) is a platform to increase and commercialize novel centered oncology remedies. In December 2025, Citius Oncology introduced LYMPHIR, licensed via the FDA for the remedy of adults with relapsed or refractory Degree I–III CTCL who had had a minimum of one prior systemic remedy. Control estimates the preliminary marketplace for LYMPHIR lately exceeds $400 million, is rising, and is underserved via present remedies. Tough highbrow assets protections that span orphan drug designation, advanced era, industry secrets and techniques and pending patents for immuno-oncology use as a mix remedy with checkpoint inhibitors would additional fortify Citius Oncology’s aggressive positioning. For more info, please talk over with www.citiusonc.com.
About Citius Prescription drugs, Inc.
Citius Prescription drugs, Inc. (Nasdaq: CTXR) is a biopharmaceutical corporate devoted to the advance and commercialization of first-in-class important care merchandise. Citius Pharma owns 79% of Citius Oncology. In December 2025, Citius Oncology introduced LYMPHIR, a centered immunotherapy for the remedy of adults with relapsed or refractory Degree I–III CTCL who had had a minimum of one prior systemic remedy. Citius Pharma’s late-stage pipeline additionally contains Mino-Lok®, a catheter lock option to salvage catheters in sufferers with catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical system for the relaxation of hemorrhoids. A pivotal Section 3 trial for Mino-Lok and a Section 2b trial for Halo-Lido have been finished in 2023. Mino-Lok met number one and secondary endpoints of its Section 3 trial. Citius Pharma is actively engaged with the FDA to stipulate subsequent steps for each techniques. For more info, please talk over with www.citiuspharma.com.
About Er-Kim
Established in 1981, Er-Kim stands at the leading edge of biopharmaceutical innovation, environment new commercialization and affected person get admission to requirements. Via strategic partnerships with over 40 international leaders, Er-Kim distributes greater than 68 merchandise to 50+ international locations, revolutionizing affected person care in global markets via fixing advanced distribution demanding situations. Er-Kim has a devoted group of over 300 execs international and revenues exceeding EUR 305M. For more info, please talk over with https://www.er-kim.com.
Ahead-Taking a look Statements
This press liberate might include “forward-looking statements” throughout the which means of Segment 27A of the Securities Act of 1933 and Segment 21E of the Securities Alternate Act of 1934. Such statements are made in accordance with our expectancies and ideology relating to long run occasions impacting Citius Oncology. You’ll determine those statements via the truth that they use phrases corresponding to “will,” “anticipate,” “estimate,” “expect,” “plan,” “should,” and “may” and different phrases and phrases of equivalent which means or use of long run dates. Ahead-looking statements are in accordance with control’s present expectancies and are topic to dangers and uncertainties that would negatively impact our industry, working effects, monetary situation and inventory value. Elements that would reason exact effects to fluctuate materially from the ones lately expected, and, except famous another way, that observe to Citius Oncology, are: our want for really extensive further price range and our talent to boost further cash to fund our operations for no less than the following 365 days as a going fear; our talent to effectively commercialize LYMPHIR and identify a sustainable income move; the estimated markets for LYMPHIR and our product applicants and the acceptance thereof via any marketplace; our talent to protected strategic partnerships and enlarge global get admission to to LYMPHIR; our talent to make use of the most recent era to fortify our commercialization efforts; doctor and affected person acceptance of LYMPHIR in a aggressive remedy panorama; our reliance on third-party logistics suppliers, vendors, and strong point pharmacies to fortify advertisement operations; our talent to teach suppliers and payers, protected ok repayment, and handle uninterrupted product provide; post-marketing necessities and ongoing regulatory compliance associated with LYMPHIR; the power of LYMPHIR and our product applicants to have an effect on the standard of lifetime of our goal affected person populations; dangers in terms of the result of analysis and construction actions, together with the ones from our present and any new pipeline property; our talent to acquire cGMP commercial-scale provide; our talent to acquire, carry out underneath and handle financing and strategic agreements and relationships; our talent to handle Nasdaq’s persevered checklist requirements; marketplace and different prerequisites; dangers associated with our expansion technique; patent and highbrow assets issues; our talent to spot, gain, shut and combine product applicants and corporations effectively and on a well timed foundation; executive law; in addition to different dangers described in our Securities and Alternate Fee (“SEC”) filings. Those dangers had been and could also be additional impacted via any long run public well being dangers. Accordingly, those forward-looking statements don’t represent promises of long run efficiency, and you’re cautioned to not position undue reliance on those forward-looking statements. Dangers referring to our industry are described intimately in our SEC filings that are to be had at the SEC’s site at www.sec.gov, together with in Citius Oncology’s Annual Record on Shape 10-Ok for the yr ended September 30, 2024, filed with the SEC on December 27, 2024, as amended on January 27, 2025, as up to date via our next filings with the SEC. Those forward-looking statements discuss most effective as of the date hereof, and we expressly disclaim any legal responsibility or endeavor to liberate publicly any updates or revisions to any forward-looking statements contained herein to mirror any exchange in our expectancies or any adjustments in occasions, prerequisites or instances on which the sort of commentary is primarily based, except for as required via regulation.
SOURCE Citius Oncology, Inc.
