Welcome to our dedicated page for Citius Oncology news (Ticker: CTOR), a resource for investors and traders seeking the latest updates and insights on Citius Oncology stock.
About Citius Oncology, Inc. (CTOR)
Citius Oncology, Inc. (Nasdaq: CTOR) is a specialized biopharmaceutical company focused on the development and commercialization of innovative targeted oncology therapies. As a majority-owned subsidiary of Citius Pharmaceuticals, Inc., the company is dedicated to addressing critical unmet medical needs in cancer treatment. Citius Oncology's flagship product, LYMPHIR™ (denileukin diftitox-cxdl), is a targeted immunotherapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with relapsed or refractory cutaneous T-cell lymphoma (CTCL) who have undergone at least one prior systemic therapy.
Core Business and Value Proposition
LYMPHIR is the only FDA-approved therapy for CTCL that specifically targets the interleukin-2 (IL-2) receptor, a unique mechanism of action that distinguishes it from other treatments. By binding to IL-2 receptors on malignant T-cells, LYMPHIR delivers cytotoxic effects, disrupting protein synthesis and leading to cancer cell death. This innovative approach addresses a significant need in the oncology market, particularly for patients with limited treatment options.
In addition to its approval for CTCL, LYMPHIR is being explored in investigator-initiated trials for its potential as a combination immunotherapy. Preliminary results from trials combining LYMPHIR with pembrolizumab (an anti-PD-1 checkpoint inhibitor) have shown promising efficacy in recurrent solid tumors, further expanding its therapeutic potential.
Market Position and Competitive Landscape
Citius Oncology operates in the growing oncology market, with management estimating the initial market size for LYMPHIR to exceed $400 million. The therapy is positioned as a critical option for CTCL patients, a segment underserved by existing treatments. Robust intellectual property protections, including orphan drug designation and pending patents for immuno-oncology use, strengthen the company's competitive edge. These protections also support its exploration of LYMPHIR's use in combination therapies, such as with CAR-T treatments for B-cell lymphomas.
Key Challenges and Strategic Initiatives
While Citius Oncology has achieved significant milestones, including FDA approval and inclusion in the NCCN Clinical Practice Guidelines in Oncology, it faces challenges such as securing sufficient financial resources and navigating a competitive oncology market. To address these, the company has engaged financial advisors to explore strategic alternatives, including partnerships and licensing opportunities. Additionally, its commercialization strategy includes securing reimbursement pathways, as evidenced by the recent assignment of a permanent J-code (J9161) for LYMPHIR by the Centers for Medicare & Medicaid Services (CMS).
Pipeline and Future Directions
Beyond LYMPHIR, Citius Oncology is actively supporting investigator-initiated trials to expand the therapeutic applications of its lead asset. These initiatives align with the company's mission to bring innovative cancer therapies to patients with high unmet medical needs. Citius Oncology's commitment to advancing oncology treatment is further demonstrated by its focus on strategic collaborations and its exploration of non-dilutive funding sources to support its operations.
Significance in the Biopharmaceutical Industry
Citius Oncology represents a critical player in the oncology sector, leveraging its expertise in targeted therapies to address complex cancers. Its focus on first-in-class treatments and its robust pipeline position the company as a significant contributor to advancements in cancer care.
Citius Pharmaceuticals (CTXR) reported its fiscal Q1 2025 results, highlighting preparations for the LYMPHIR commercial launch in H1 2025. The company secured a new J-code (J9161) for LYMPHIR, effective April 1, 2025, and reported promising preliminary results from an ongoing Phase I trial combining LYMPHIR with pembrolizumab.
Financial results showed cash and cash equivalents of $1.1 million as of December 31, 2024. The company reported a net loss of $10.3 million ($1.30 per share), compared to $9.2 million ($1.45 per share) in the prior year. R&D expenses decreased to $2.1 million from $2.6 million, while G&A expenses increased to $5.4 million from $3.7 million.
The company raised $6.5 million through offerings in late 2024 and early 2025, completed a 1-for-25 reverse stock split, and regained Nasdaq compliance.
Citius Oncology (NASDAQ: CTOR) reported its fiscal Q1 2025 financial results and business updates. The company has engaged Jefferies to explore strategic alternatives for maximizing shareholder value. Key developments include preparation for LYMPHIR™ launch in H1 2025, with inventory ready and a new permanent J-code (J9161) effective April 1, 2025.
Financial results show R&D expenses of $1.3M (vs $1.2M in Q1 2024), G&A expenses of $3.3M (vs $1.5M), and stock-based compensation of $1.8M (vs $1.9M). The company reported a net loss of $6.7M ($0.09 per share) compared to $4.7M ($0.07 per share) in Q1 2024.
Two investigator-initiated trials are exploring LYMPHIR's potential in combination therapies, with interim results presented at SITC Conference showing promise in combination with pembrolizumab for recurrent solid tumors.
Citius Pharmaceuticals and Citius Oncology announced that LYMPHIR™ (denileukin diftitox-cxdl) has received a permanent Healthcare Common Procedure Coding System (HCPCS) J-code (J9161) from the Centers for Medicare & Medicaid Services. The code will be effective April 1, 2025.
LYMPHIR is FDA-approved for treating adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. The permanent J-code will help streamline billing and reimbursement processes for healthcare providers administering LYMPHIR, facilitating access for patients with commercial and government insurance coverage.
Citius Pharmaceuticals and its subsidiary Citius Oncology announced preparations for the commercial launch of LYMPHIR™ in the first half of 2025. LYMPHIR, approved in August 2024, is an immunotherapy treatment for adults with relapsed or refractory cutaneous T-cell lymphoma (CTCL).
The companies have made significant progress in key launch areas including: securing commercial supply agreements and producing first-year launch supply; implementing healthcare provider education programs; working on reimbursement pathways; submitting for a unique J-code; securing inclusion in NCCN guidelines; developing patient assistance programs; and building a specialized sales team.
Management is also exploring additional growth opportunities through international licensing partnerships and potential expanded indications for LYMPHIR, including its use as a combination immunotherapy.
Citius Oncology (Nasdaq: CTOR), a majority-owned subsidiary of Citius Pharmaceuticals (Nasdaq: CTXR), has engaged Jefferies as its exclusive financial advisor to explore strategic alternatives for maximizing shareholder value. The company is considering various options including partnerships, joint ventures, mergers, acquisitions, and licensing transactions.
The announcement comes as Citius Oncology prepares to launch LYMPHIR™, their recently FDA-approved therapy for treating patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) who have undergone at least one prior systemic therapy.
The company has not established a specific timeline for this strategic review process and will only disclose developments if the Board of Directors approves a specific transaction or deems disclosure necessary. There is no guarantee that this process will result in any strategic transaction.
Citius Pharmaceuticals (CTXR) reported fiscal year 2024 results, highlighting key achievements including FDA approval of LYMPHIR™ for CTCL treatment and positive Phase 3 trial results for Mino-Lok®. The company reported cash and equivalents of $3.3 million as of September 30, 2024. Financial results show R&D expenses decreased to $11.9 million from $14.8 million, while G&A expenses increased to $18.2 million from $15.3 million. Net loss widened to $39.4 million ($5.97 per share) compared to $32.5 million ($5.57 per share) in 2023. The company completed merger of its oncology subsidiary to form Citius Oncology (CTOR) and plans LYMPHIR commercial launch in first half of 2025.
Citius Oncology (NASDAQ: CTOR) reported its fiscal year 2024 results and key developments. The company achieved FDA approval for LYMPHIR™, an immunotherapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL), and began trading on Nasdaq under CTOR in August 2024. The company is preparing for LYMPHIR's commercial launch in H1 2025, including manufacturing inventory and initiating sales force recruitment.
Financial results showed R&D expenses of $4.9M (up from $4.2M in 2023), G&A expenses of $8.1M (up from $5.9M), and stock-based compensation of $7.5M (up from $2.0M). Net loss widened to $21.1M ($0.31 per share) compared to $12.7M ($0.19 per share) in 2023.
Citius Pharmaceuticals and Citius Oncology announced preliminary results from a Phase I trial evaluating the combination of pembrolizumab (KEYTRUDA®) and LYMPHIR™ in patients with recurrent solid tumors, focusing on gynecological cancers like ovarian, endometrial, and cervical. The trial showed a 27% Objective Response Rate (ORR) and a 33% Clinical Benefit Rate (CBR) with a median Progression-Free Survival (PFS) of 57 weeks. The regimen was well-tolerated, with no serious immune-related adverse events. The study, nearing completion, will enroll three more patients. The results suggest LYMPHIR may enhance the efficacy of immune checkpoint inhibitors like pembrolizumab. The trial's promising outcomes support expanding research into a Phase II study to evaluate the combination's benefits across a broader range of solid tumors.
Citius Pharmaceuticals (CTXR) announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference from September 9-11, 2024, in New York City. CEO Leonard Mazur will present on September 10, 2024, at 9:00 am ET at the Lotte New York Palace Hotel and host one-on-one investor meetings.
Key business developments to be discussed include:
- FDA approval of LYMPHIR™ for cutaneous T-cell lymphoma treatment
- Merger of a subsidiary with TenX Keane, forming Citius Oncology (CTOR)
- Successful Phase 3 Pivotal Trial of Mino-Lok®, an antibiotic lock solution for catheter-related bloodstream infections
Investors can register on the conference website and join the live webcast presentation.
Citius Pharmaceuticals and Citius Oncology announced that LYMPHIR™ has been added to the NCCN Clinical Practice Guidelines in Oncology with a Category 2A recommendation. This inclusion supports LYMPHIR as an appropriate treatment option for patients with Cutaneous T-cell Lymphoma (CTCL) who have undergone at least one prior systemic therapy.
LYMPHIR, a novel immunotherapy targeting the interleukin-2 receptor on malignant T-cells and Tregs, was recently approved by the FDA based on results from the Phase 3 Pivotal Study 302. The addition to NCCN Guidelines is expected to facilitate adoption and ease reimbursement, particularly for patients eligible for CMS coverage.
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