Citius Oncology Ships First International Order of LYMPHIR™ to Europe

Rhea-AI Summary

Citius Oncology (Nasdaq: CTOR) announced its first shipment of LYMPHIR (denileukin diftitox-cxdl) to Europe via a regional distribution partner on April 29, 2026, expanding patient access outside the United States.

LYMPHIR will be available through Named Patient Programs in specific countries under local regulations; it lacks EMA marketing authorization. The company continues U.S. commercial rollout after FDA approval in August 2024 and a December 2025 U.S. launch.

Positive

• First commercial LYMPHIR shipment to Europe via regional partner
• European access enabled through Named Patient Programs
• U.S. FDA approval in August 2024 and U.S. commercial launch December 2025

Negative

• No European Medicines Agency marketing authorization for LYMPHIR
• Access in Europe limited to Named Patient Programs, not broad market approval

News Market Reaction – CTOR

-0.80%

2 alerts

-0.80% Session close to close

$71.86M Market Cap

0.3x Rel. Volume

In the Apr 29 session, CTOR declined 0.80%, reflecting a mild negative market reaction. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement extends LYMPHIR access outside the U.S. through European Named Patient Programs, w...

Analysis

This announcement extends LYMPHIR access outside the U.S. through European Named Patient Programs, while full marketing authorization remains outstanding. It builds on earlier FDA approval in August 2024 and the U.S. launch in December 2025, reinforcing Citius Oncology’s shift to a commercial model. Recent filings highlight both initial revenue traction and ongoing listing and capital-structure risks, so future updates on European demand, reimbursement, and formal regulatory pathways will be important to monitor.

Key Figures

FDA approval date: August 2024 US commercial launch: December 2025 Disease stage: Stage I–III +1 more

4 metrics

FDA approval date August 2024 LYMPHIR approval for adult Stage I–III relapsed or refractory CTCL

US commercial launch December 2025 Initial U.S. commercial launch of LYMPHIR

Disease stage Stage I–III Indicated CTCL stages for LYMPHIR treatment

Prior therapy requirement At least one Required prior systemic therapy before LYMPHIR use

Historical Context

5 past events · Latest: Mar 31 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Mar 31	Commercial launch update	Positive	+25.7%	Reported early LYMPHIR launch momentum with expanding formulary access and payer coverage.
Mar 24	Conference participation	Neutral	-6.8%	Outlined USCLC workshop participation to discuss CTCL care and LYMPHIR experience.
Mar 10	Phase 1 topline data	Positive	-0.5%	Released positive Phase 1 data of LYMPHIR plus pembrolizumab in gynecologic cancers.
Mar 4	Phase 1 topline data	Positive	+2.8%	Shared strong response and survival metrics using LYMPHIR before commercial CAR-T therapy.
Feb 13	Initial revenue report	Positive	+3.4%	Announced first LYMPHIR revenue and transition to commercial-stage oncology company.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Positive LYMPHIR-related updates have often produced favorable reactions, but several clinically positive releases saw muted or negative price moves.

Recent Company History

Over the last few months, Citius Oncology has focused on building the commercial and clinical story around LYMPHIR. A March 31 commercial update highlighting growing formulary adoption and payer coverage coincided with a 25.74% gain. Earlier, the first reported LYMPHIR revenue of $3.9M in Q1 2026 saw a smaller positive move. Multiple Phase 1 datasets, including a 24% ORR and 86% ORR in combination settings, received mixed market reactions. Today’s first European shipment extends the access narrative beyond the U.S., building on this commercialization trajectory.

Key Terms

denileukin diftitox-cxdl, cutaneous t-cell lymphoma, named patient programs, european medicines agency, +1 more

5 terms

denileukin diftitox-cxdl medical

"LYMPHIR™ (denileukin diftitox-cxdl) to Europe through one of its regional"

An engineered therapeutic protein that links a cell-targeting signal to a bacterial toxin so the toxin is delivered specifically to certain immune cells; think of it as a guided missile that kills only the cells carrying the matching marker. For investors, it matters because successful clinical results or regulatory approval can create a new product revenue stream but also carry clinical, regulatory and manufacturing risks that can strongly affect a company’s financial outlook.

cutaneous t-cell lymphoma medical

"for the treatment of adult patients with Stage I–III relapsed or refractory cutaneous T-cell lymphoma"

Cutaneous T-cell lymphoma is a rare type of skin cancer that develops when certain immune system cells grow uncontrollably, causing skin patches, rashes, or tumors. While it primarily affects health, its rarity and complexity can influence medical research funding and pharmaceutical development, which may impact investment opportunities in healthcare and biotech sectors. Understanding such diseases helps investors gauge potential risks and innovations in medical treatments.

named patient programs regulatory

"available to eligible patients through Named Patient Programs (NPPs) in accordance"

Named patient programs are arrangements that allow patients to access experimental or unapproved medicines outside of regular clinical trials, often through special approvals. They matter to investors because they can signal a company's efforts to bring new treatments to market and may impact perceptions of future sales potential or regulatory progress. These programs can also influence a company's reputation and relationships within the healthcare industry.

european medicines agency regulatory

"LYMPHIR does not have marketing authorization from the European Medicines Agency in Europe"

The European Medicines Agency is the central drug regulator that evaluates and authorizes medicines for use across the European Union and related countries, similar to a referee or safety inspector who checks that a medicine is safe and effective before it can be sold. Its decisions matter to investors because approvals, rejections, or safety warnings directly affect a drug maker’s ability to sell products, generate revenue, and face legal or reputational risks, which in turn influence stock value.

marketing authorization regulatory

"LYMPHIR does not have marketing authorization from the European Medicines Agency"

An official government approval that allows a drug, vaccine, or medical device to be sold and promoted in a specific country or region. Think of it as a safety and effectiveness passport issued after regulators review the product’s tests and manufacturing; for investors, receiving this authorization typically unlocks sales, revenue potential, and lower regulatory risk, while delays or denials can substantially affect a company’s value and timeline.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Order fulfilment expands international patient access to LYMPHIR following initial U.S. launch

Distribution by regional partners through Named Patient Programs in specific international markets

CRANFORD, N.J., April 29, 2026 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), an oncology‑focused biopharmaceutical company and majority‑owned subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today announced the initial shipment of LYMPHIR™ (denileukin diftitox-cxdl) to Europe through one of its regional distribution partners, marking an important milestone in expanding access to the therapy for patients outside the United States. LYMPHIR will be made available to eligible patients through Named Patient Programs (NPPs) in accordance with local regulations in each country.

The initiation of European distribution represents a strategic step in the Company's broader effort to extend access to LYMPHIR for patients with limited treatment options, while continuing to prioritize disciplined and targeted market entry.

"Reaching this milestone underscores our commitment to ensuring that patients in need can access LYMPHIR beyond the United States," said Leonard Mazur, Chairman and Chief Executive Officer of Citius Oncology. "Through our distribution partners, we are enabling physicians to request LYMPHIR for appropriate patients via established Named Patient Programs, providing a pathway to treatment where approved alternatives may be limited. Importantly, this progress complements the strong early foundation we are building in the U.S., where we continue to see encouraging adoption across key treatment centers."

In the United States, Citius Oncology continues to execute its commercial launch strategy, with ongoing progress in formulary access, expanding payer coverage, and increasing engagement across both academic and community oncology settings. The Company remains focused on supporting physician education and facilitating patient access as LYMPHIR becomes integrated into clinical practice.

LYMPHIR was approved by the U.S. Food and Drug Administration in August 2024 for the treatment of adult patients with Stage I–III relapsed or refractory cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy, and was commercially launched in the United States in December 2025.

LYMPHIR does not have marketing authorization from the European Medicines Agency in Europe or other countries outside the United States. Access is being provided solely through Named Patient Programs in accordance with applicable local laws and regulations.

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 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.

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 are: our ability to successfully commercialize LYMPHIR and establish a sustainable revenue stream; our ability to secure and maintain strategic partnerships and expand international access to LYMPHIR; the estimated markets for LYMPHIR and our product candidates and the acceptance thereof by any market; risks relating to the results of research and development activities, including those from our existing and any new pipeline assets; 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; early-stage clinical data may not be predictive of results from larger or later-stage studies; our ability to maintain Nasdaq's continued listing standards; our ability to use the latest technology to support our commercialization efforts for LYMPHIR; 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; 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; 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. 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.

LYMPHIR™ (denileukin diftitox‑cxdl)

INDICATION

LYMPHIR is an IL2-receptor-directed cytotoxin indicated for the treatment of adult patients with r/r Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

IMPORTANT SAFETY INFORMATION

BOXED WARNING: CAPILLARY LEAK SYNDROME

Capillary leak syndrome (CLS), including life-threatening or fatal reactions, can occur in patients receiving LYMPHIR. Monitor patients for signs and symptoms of CLS during treatment. Withhold LYMPHIR until CLS resolves, or permanently discontinue based on severity.

WARNINGS AND PRECAUTIONS

Capillary Leak Syndrome

LYMPHIR can cause capillary leak syndrome (CLS), including life-threatening or fatal reactions. CLS was defined in the clinical trials as the occurrence of at least 2 of the following symptoms at any time during LYMPHIR therapy: hypotension, edema, and serum albumin <3 g/dL. These symptoms were not required to occur simultaneously to be characterized as capillary leak syndrome.

As defined, CLS occurred in 27% of patients in the pooled population across 3 clinical trials, including 8% with Grade 3. There was one (0.8%) fatal occurrence of CLS. Of the patients with CLS, 22% had recurrence. The majority of CLS events (81%) occurred within the first 2 cycles of treatment. The median time to onset from Cycle 1, Day 1 was 6.5 days (range: 1 to 77), the median duration of CLS was 14 days (range: 2 to 40), and 75% of patients had resolution. The most common symptoms included edema, hypoalbuminemia, and hypotension. Pleural effusion, pericardial effusion, and dehydration also occurred.

Regularly assess patients for weight gain, new onset or worsening of edema, dyspnea, and hypotension (including orthostatic changes). Monitor serum albumin levels prior to the initiation of each cycle of therapy and more often as clinically indicated.

Withhold, reduce dose, or permanently discontinue based on severity. If LYMPHIR is withheld, resume LYMPHIR following resolution of CLS and when serum albumin is greater than or equal to 3 g/dL.

Visual Impairment

LYMPHIR can cause serious visual impairment, including changes in visual acuity and color vision. In the pooled population across 3 clinical trials, visual impairment occurred in 9%, with Grade 1 in 8% and Grade 2 in 1%. The most commonly reported symptom was blurred vision. Of the patients with visual impairment, 67% had resolution of their visual impairment.

Perform baseline ophthalmic examination and monitor as clinically indicated. If patients experience symptoms of visual impairment, such as changes in visual acuity, changes in color vision, or blurred vision, refer for ophthalmologic evaluation.

Withhold LYMPHIR until visual impairment resolves or permanently discontinue based on severity.

Infusion-Related Reactions

LYMPHIR can cause serious infusion-related reactions. Infusion-related reactions were reported in 69% of patients in the pooled population across 3 clinical trials of patients who received LYMPHIR, with Grade 3 infusion-related reactions in 3.4%. Eighty-three percent of infusion-related reactions occurred in Cycles 1 and 2. The most common symptoms included nausea, fatigue, chills, musculoskeletal pain, vomiting, fever, and arthralgia.

Premedicate patients for the first three cycles prior to starting a LYMPHIR infusion. Monitor patients frequently during infusion. For Grade 2 or higher infusion reactions, premedicate at least 30 minutes prior to each subsequent infusion with a systemic steroid for at least 3 cycles.

Interrupt or discontinue LYMPHIR based on severity. Institute appropriate medical management.

Hepatotoxicity

LYMPHIR can cause hepatotoxicity. In the pooled safety population, elevated ALT occurred in 70% of patients, with Grade 3 ALT occurring in 22%; elevated AST occurred in 64% of patients, with Grade 3 AST elevation occurring in 9%. For Grade 3 events, median time to onset was 8 days (range: 1 to 15 days); median time to resolution was 15 days (range: 7 to 50 days); all cases of Grade 3 ALT or AST elevations resolved. Elevated total bilirubin occurred in 5% of patients, with Grade 3 occurring in 0.9%.

Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold, reduce dose, or permanently discontinue LYMPHIR based on severity.

Embryo-Fetal Toxicity

Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman. Verify the pregnancy status of females of reproductive potential prior to the initiation of LYMPHIR. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment and for 7 days following the last dose of LYMPHIR.

ADVERSE REACTIONS

The most common adverse reactions (≥20%), including laboratory abnormalities, are increased transaminases, albumin decreased, nausea, edema, hemoglobin decreased, fatigue, musculoskeletal pain, rash, chills, constipation, pyrexia, and capillary leak syndrome.

USE IN SPECIFIC POPULATIONS

Pregnancy

Risk Summary
Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman. There are no available data on the use of LYMPHIR in pregnant women to evaluate for a drug-associated risk. No animal reproductive and developmental toxicity studies have been conducted with denileukin diftitox.

Denileukin diftitox-cxdl causes depletion of regulatory T lymphocytes (Treg), immune activation, and capillary leak syndrome, compromising pregnancy maintenance. Advise pregnant women of the potential risk to a fetus.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2-4% and 15-20%, respectively.

Lactation

Risk Summary
No data are available regarding the presence of denileukin diftitox-cxdl in human milk, the effects on the breastfed child, or on milk production. Because of the potential for serious adverse reactions in breastfed children, advise women not to breastfeed during treatment with LYMPHIR and for 7 days after the last dose.

Females and Males of Reproductive Potential

Based on its mechanism of action, LYMPHIR can cause fetal harm when administered to a pregnant woman.

Pregnancy Testing
Verify the pregnancy status of females of reproductive potential prior to initiating LYMPHIR.

Contraception

Females
Advise females of reproductive potential to use effective contraception during treatment with LYMPHIR and for 7 days after the last dose.

Infertility

Males
Based on findings in rats, male fertility may be compromised by treatment with LYMPHIR. The reversibility of the effect on fertility is unknown.

Pediatric Use
Safety and effectiveness of LYMPHIR in pediatric patients have not been established.

Geriatric Use
Of the 69 patients with Stage I-III r/r CTCL who received LYMPHIR, 34 patients (49%) were 65 years of age and older and 10 patients (14%) were 75 years of age and older. Clinical studies of LYMPHIR did not include sufficient numbers of patients 65 years of age and older to determine whether they respond differently from younger adult patients. 

You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Citius Oncology at 1-844-459-6744.

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

Investor Contact:
Ilanit Allen
ir@citiuspharma.com
908-967-6677 x113

Media Contact:
STiR-communications
Greg Salsburg
Greg@STiR-communications.com 

 

View original content to download multimedia:https://www.prnewswire.com/news-releases/citius-oncology-ships-first-international-order-of-lymphir-to-europe-302757013.html

SOURCE Citius Oncology, Inc.

FAQ

What did Citius Oncology (CTOR) announce about LYMPHIR on April 29, 2026?

Citius Oncology announced the first shipment of LYMPHIR to Europe through a regional distribution partner. According to the company, LYMPHIR will be provided to eligible patients via Named Patient Programs under local laws, expanding access outside the United States.

How will European patients access LYMPHIR (CTOR) now that shipments began?

European patients will access LYMPHIR through Named Patient Programs in eligible countries. According to the company, physicians can request LYMPHIR for appropriate patients in line with local regulations and program procedures.

Does LYMPHIR have EMA approval for use in Europe as of April 29, 2026?

No, LYMPHIR does not have marketing authorization from the European Medicines Agency. According to the company, European access is being provided solely via Named Patient Programs under applicable local laws.

What is LYMPHIR approved for in the United States and when was it launched?

LYMPHIR is FDA-approved for adult Stage I–III relapsed or refractory CTCL after one prior systemic therapy. According to the company, approval occurred in August 2024 and commercial launch in the U.S. was December 2025.

What does the CTOR European shipment mean for the company's U.S. commercial progress?

The shipment complements ongoing U.S. commercial rollout and access efforts. According to the company, work continues on formulary access, payer coverage expansion, and physician education across academic and community settings.