Citius Oncology Introduces LYMPHIR, The First New Systemic Treatment for CTCL in More Than Seven Years
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 02 2025
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Should l Buy CTOR?
Source: NASDAQ.COM
Launch of LYMPHIR: Citius Oncology has launched LYMPHIR, an immunotherapy for adults with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL), marking the first FDA-approved systemic therapy for this condition in over seven years.
Clinical Efficacy: The FDA approval was based on Pivotal Study 302, which showed a 36.2% Objective Response Rate and significant relief from severe itching, with a median time to response of just 1.4 months and no cumulative toxicity.
Market Potential: LYMPHIR enters a U.S. market valued at over $400 million, with opportunities for international expansion and potential label extensions, as Citius focuses on ensuring the therapy reaches patients in need.
Company Insights: Citius executives highlighted the importance of LYMPHIR in addressing a significant clinical need in CTCL treatment, with expectations for it to enhance shareholder value and improve patient quality of life.
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Analyst Views on CTOR
About CTOR
Citius Oncology, Inc. is a biopharmaceutical company. The Company is focused on developing and commercializing targeted oncology therapies. The Company’s lead product candidate is LYMPHIR, an engineered IL-2 diphtheria toxin fusion protein, for the treatment of patients with persistent or recurrent CTCL, a rare form of non-Hodgkin lymphoma. 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 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 diphtheria toxin (DT) fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Citius Pharmaceuticals Reports $3.9 Million Revenue in Q1 2026
- Revenue Milestone: Citius Pharmaceuticals successfully launched LYMPHIR in December 2025, generating $3.9 million in revenue during Q1 2026, marking a significant transition to a revenue-generating company and reflecting initial success in the cutaneous T-cell lymphoma treatment market.
- Market Potential Assessment: The initial market for LYMPHIR is estimated to exceed $400 million and is underserved by existing therapies, highlighting strategic opportunities and growth potential for Citius in the oncology treatment sector.
- Pipeline Progress: Citius's late-stage pipeline includes Mino-Lok and Halo-Lido, with the former completing a pivotal Phase 3 trial in 2023 and meeting primary and secondary endpoints, which is expected to further drive future revenue growth for the company.
- Financial Stewardship Commitment: The company is committed to financial stewardship to sustain growth momentum while focusing on advancing its late-stage pipeline, aiming to maximize long-term shareholder value through the provision of first-in-class critical care products.
See More
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- Initial Sales Revenue: Citius Oncology successfully launched LYMPHIR in December 2025, generating $3.9 million in initial sales revenue, marking a pivotal transition from a development-stage organization to a commercial entity, which is expected to significantly enhance future market share and investor confidence.
- Significant Market Potential: The market for LYMPHIR, targeting relapsed or refractory Stage I-III CTCL, is estimated to exceed $400 million and remains underserved by existing therapies, indicating a strategic positioning for long-term growth in the oncology treatment landscape.
- Accelerating Physician Adoption: Since the beginning of 2026, physicians have started initiating patients on LYMPHIR, with the company focusing on accelerating adoption rates and expanding patient access, which will directly drive sales growth and enhance competitive positioning in the market.
- Strategic Investment and Execution: Citius Oncology plans to leverage an advanced AI-enabled commercial platform to support market penetration, with management emphasizing ongoing capital management and evaluation of strategic opportunities to enhance long-term shareholder value, ensuring the company maintains a competitive edge in a rapidly evolving market.
See More
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- Enhanced Expert Validation: Oncolytics expanded its Gastrointestinal Tumor Scientific Advisory Board with three globally recognized experts, further elevating the academic validation and industry attention for pelareorep, which may attract more investment and collaboration opportunities.
- Successful FDA Alignment: Oncolytics has secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, marking the launch of the only immunotherapy registration trial planned for this disease, thereby enhancing its market competitiveness.
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- Investigation Launched: Purcell & Lefkowitz LLP is investigating Citius Oncology, Inc. to determine if the company's directors breached their fiduciary duties in recent corporate actions, which could significantly impact shareholder rights.
- Shareholder Rights Protection: The investigation focuses on safeguarding the interests of Citius Oncology shareholders, and those interested in more information can visit the firm's website or contact an attorney, highlighting the importance of shareholder rights.
- Legal Support: Purcell & Lefkowitz LLP is dedicated to representing shareholders nationwide in cases of securities fraud and breaches of fiduciary duty, demonstrating their expertise in protecting shareholder interests.
- Potential Impact: This investigation may negatively affect shareholder confidence in Citius Oncology, potentially impacting its stock price performance and reflecting underlying risks in the company's governance structure.
See More
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- Market Access: The company secured a permanent J-code (J9161) and a National Comprehensive Cancer Network Category 2A recommendation, ensuring widespread availability of the drug in the U.S., which enhances its competitive position in the market.
- Financial Performance: Citius reported a net loss of $39.7 million for fiscal 2025, an improvement from the $40.2 million loss in fiscal 2024, demonstrating efforts in controlling R&D expenses, although the company has yet to generate revenue.
- Capital Raising: The company raised approximately $61 million in gross proceeds through capital raises, yet reported only $4.3 million in cash and cash equivalents, reflecting challenges in financial management and future operations.
See More
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- Revenue Milestone: Citius Pharmaceuticals successfully launched LYMPHIR in December 2025, generating $3.9 million in revenue during Q1 2026, marking a significant transition to a revenue-generating company and reflecting initial success in the cutaneous T-cell lymphoma treatment market.
- Market Potential Assessment: The initial market for LYMPHIR is estimated to exceed $400 million and is underserved by existing therapies, highlighting strategic opportunities and growth potential for Citius in the oncology treatment sector.
- Pipeline Progress: Citius's late-stage pipeline includes Mino-Lok and Halo-Lido, with the former completing a pivotal Phase 3 trial in 2023 and meeting primary and secondary endpoints, which is expected to further drive future revenue growth for the company.
- Financial Stewardship Commitment: The company is committed to financial stewardship to sustain growth momentum while focusing on advancing its late-stage pipeline, aiming to maximize long-term shareholder value through the provision of first-in-class critical care products.
See More
Citius Oncology Reports $3.9 Million in Initial Sales Revenue
- Initial Sales Revenue: Citius Oncology successfully launched LYMPHIR in December 2025, generating $3.9 million in initial sales revenue, marking a pivotal transition from a development-stage organization to a commercial entity, which is expected to significantly enhance future market share and investor confidence.
- Significant Market Potential: The market for LYMPHIR, targeting relapsed or refractory Stage I-III CTCL, is estimated to exceed $400 million and remains underserved by existing therapies, indicating a strategic positioning for long-term growth in the oncology treatment landscape.
- Accelerating Physician Adoption: Since the beginning of 2026, physicians have started initiating patients on LYMPHIR, with the company focusing on accelerating adoption rates and expanding patient access, which will directly drive sales growth and enhance competitive positioning in the market.
- Strategic Investment and Execution: Citius Oncology plans to leverage an advanced AI-enabled commercial platform to support market penetration, with management emphasizing ongoing capital management and evaluation of strategic opportunities to enhance long-term shareholder value, ensuring the company maintains a competitive edge in a rapidly evolving market.
See More
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- Market Potential: The global cancer drugs market is projected to reach $594.3 billion by 2035, with high-tech immunotherapies replacing traditional chemotherapy, positioning Oncolytics Biotech Inc. as a key player in this transformation.
- Clinical Data Breakthrough: Oncolytics' pelareorep achieved a 33% objective response rate in second-line KRAS-mutant microsatellite-stable metastatic colorectal cancer patients when combined with standard chemotherapy, significantly surpassing the historical 6-11% response rate for chemotherapy alone, potentially driving growth in a $20 billion market.
- Enhanced Expert Validation: Oncolytics expanded its Gastrointestinal Tumor Scientific Advisory Board with three globally recognized experts, further elevating the academic validation and industry attention for pelareorep, which may attract more investment and collaboration opportunities.
- Successful FDA Alignment: Oncolytics has secured FDA alignment on its Phase 3 study design for pelareorep in first-line metastatic pancreatic cancer, marking the launch of the only immunotherapy registration trial planned for this disease, thereby enhancing its market competitiveness.
See More
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- Market Potential: The global cancer drugs market is projected to reach $594.3 billion by 2035, with high-tech immunotherapies gradually replacing traditional chemotherapy, positioning Oncolytics Biotech as a key player in this transformation.
- Significant Efficacy: Oncolytics' pelareorep achieved a 33% objective response rate in second-line KRAS-mutant microsatellite-stable metastatic colorectal cancer patients when combined with standard chemotherapy, tripling the historical 6-11% response rate, with the colorectal cancer market expected to reach $20 billion by 2033.
- Enhanced Academic Validation: Oncolytics expanded its Gastrointestinal Tumor Scientific Advisory Board with three globally recognized experts, further enhancing its reputation in academia and attracting attention from the pharmaceutical industry.
- FDA Support: Oncolytics secured FDA alignment on its Phase 3 study design for first-line metastatic pancreatic cancer, marking the launch of the only immunotherapy registration trial planned for this disease, indicating strong strategic prospects in cancer treatment.
See More
Citius Oncology Under Investigation for Potential Fiduciary Breaches Affecting Shareholders
- Investigation Launched: Purcell & Lefkowitz LLP is investigating Citius Oncology, Inc. to determine if the company's directors breached their fiduciary duties in recent corporate actions, which could significantly impact shareholder rights.
- Shareholder Rights Protection: The investigation focuses on safeguarding the interests of Citius Oncology shareholders, and those interested in more information can visit the firm's website or contact an attorney, highlighting the importance of shareholder rights.
- Legal Support: Purcell & Lefkowitz LLP is dedicated to representing shareholders nationwide in cases of securities fraud and breaches of fiduciary duty, demonstrating their expertise in protecting shareholder interests.
- Potential Impact: This investigation may negatively affect shareholder confidence in Citius Oncology, potentially impacting its stock price performance and reflecting underlying risks in the company's governance structure.
See More
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- New Drug Launch: Citius Pharmaceuticals' LYMPHIR became commercially available in December, marking the first new CTCL therapy since 2018, with an estimated initial market size exceeding $400 million, indicating significant progress in the oncology treatment sector.
- Market Access: The company secured a permanent J-code (J9161) and a National Comprehensive Cancer Network Category 2A recommendation, ensuring widespread availability of the drug in the U.S., which enhances its competitive position in the market.
- Financial Performance: Citius reported a net loss of $39.7 million for fiscal 2025, an improvement from the $40.2 million loss in fiscal 2024, demonstrating efforts in controlling R&D expenses, although the company has yet to generate revenue.
- Capital Raising: The company raised approximately $61 million in gross proceeds through capital raises, yet reported only $4.3 million in cash and cash equivalents, reflecting challenges in financial management and future operations.
See More
