Citius Oncology Expands International Distribution of LYMPHIR™ to European Union Through Exclusive Agreement with Uniphar
Rhea-AI Summary
Citius Oncology (NASDAQ: CTOR) entered an exclusive distribution agreement with Uniphar to expand access to LYMPHIR™ (denileukin diftitox-cxdl) in designated territories across Western and Eastern Europe via country-specific managed access programs.
Uniphar will manage market access and distribution where permitted by local law; Citius Oncology will supply finished product and provide ongoing support. LYMPHIR is not approved for commercial use outside the United States and will be provided only through managed access programs, which do not constitute marketing authorization.
Positive
- Exclusive distribution with Uniphar covers Western and Eastern Europe
- Third international distribution partnership, advancing global access strategy
- Uses established regional partner to manage market access and distribution
Negative
- LYMPHIR is not approved for commercial use outside the United States
- Supply limited to country-specific managed access programs, not marketing authorization
- No commercial launch or pricing/financial terms disclosed in the agreement
News Market Reaction – CTOR
On the day this news was published, CTOR declined NaN%, reflecting a moderate negative market reaction. Argus tracked a peak move of +6.8% during that session. Argus tracked a trough of -10.2% from its starting point during tracking. Our momentum scanner triggered 9 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Market Reality Check
Peers on Argus
CTOR was up 1.8% while close peers showed mixed moves: ANIK +1.97%, DERM +0.62%, and others like IRWD and BIOA down, indicating a stock-specific move rather than a coordinated sector shift.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Dec 23 | Earnings & update | Neutral | +1.6% | Fiscal 2025 results, LYMPHIR U.S. launch progress, multiple strategic financings. |
| Dec 23 | Earnings & launch | Neutral | +1.6% | Fiscal 2025 results, LYMPHIR launch, expanded access and reimbursement milestones. |
| Dec 10 | Financing close | Negative | -2.6% | Closing of concurrent registered direct offering and private placement raising $18M. |
| Dec 09 | Financing announcement | Negative | +6.4% | Announcement of $18M concurrent registered direct offering and private placement. |
| Dec 04 | Intl. distribution deal | Positive | -8.2% | Exclusive LYMPHIR distribution agreement covering Turkey and multiple Middle East states. |
Financing announcements have produced mixed reactions, while international LYMPHIR deals have not consistently lifted the stock.
Over the last few months, CTOR has combined commercialization steps for LYMPHIR with capital-raising. December 2025 offerings and warrant repricings raised about $18M, alongside a primary offering of 1,284,404 shares at $1.09. The company also secured an exclusive LYMPHIR distribution deal for Turkey and the Middle East and reported fiscal 2025 results highlighting U.S. launch progress, multiple financings totaling tens of millions of dollars, and international named patient access in 19 markets. Today’s Europe-focused agreement extends that international access strategy.
Market Pulse Summary
This announcement extends Citius Oncology’s global access strategy for LYMPHIR, adding an exclusive European distribution partner using managed access programs where permitted. It builds on prior agreements that expanded availability to 19 non-U.S. markets. Recent history also includes multiple financings and warrant approvals to support commercialization. Investors may watch how quickly these regional partnerships translate into patient uptake and how the company balances growth initiatives with potential dilution from existing equity instruments.
Key Terms
managed access programs regulatory
cutaneous T-cell lymphoma medical
relapsed or refractory medical
AI-generated analysis. Not financial advice.
Third international distribution agreement further advances global access strategy with major markets in
Under the terms of the agreement, Uniphar will serve as the exclusive distribution partner for LYMPHIR in designated international territories in Western and
"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
This agreement follows Citius Oncology's previously announced international distribution partnerships, including exclusive arrangements in
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
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
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
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
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.
FAQ
What territories will Citius Oncology (CTOR) cover under the Uniphar distribution agreement?
Is LYMPHIR commercially approved in Europe under the CTOR–Uniphar agreement?
What role will Uniphar play in distributing LYMPHIR for CTOR?
Will Citius Oncology (CTOR) supply the LYMPHIR product under the agreement?
Does the Uniphar agreement guarantee a commercial launch of LYMPHIR in EU markets?
