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NEW YORK - Citius Oncology, Inc. (NASDAQ:CTOR) announced Tuesday that final preparations are underway for the commercial launch of LYMPHIR, its FDA-approved immunotherapy for relapsed or refractory cutaneous T-cell lymphoma (CTCL), planned for the second half of 2025. The company’s stock has shown strong momentum recently, with a 25% gain over the past six months, according to InvestingPro data.
The company reported completion of commercial-scale manufacturing with packaged inventory now held at a contract manufacturing organization. According to the company, sufficient inventory with a 60-month shelf life has been produced to meet projected demand for 12-18 months post-launch.
Citius Oncology has established distribution agreements with pharmaceutical logistics partners to support nationwide delivery of the treatment to both major cancer centers and community settings.
The company stated that LYMPHIR has been included in the National Comprehensive Cancer Network Clinical Practice Guidelines and assigned a permanent J-code under HCPCS, positioning the product for reimbursement at launch.
"We’ve made steady and meaningful progress toward commercialization over the past several months," said Leonard Mazur, Chairman and CEO of Citius Oncology and Citius Pharma.
LYMPHIR (denileukin diftitox-cxdl) received FDA approval in August 2024 for the treatment of adults with Stage I-III CTCL after at least one prior systemic therapy. The drug is a recombinant fusion protein that targets IL-2 receptors on tumor cells.
Citius Oncology, which is 92% owned by Citius Pharmaceuticals (NASDAQ:CTXR), noted that it is actively engaged in strategic partnership discussions to expand LYMPHIR’s market reach.
This article is based on a press release statement from Citius Oncology.
In other recent news, Citius Pharmaceuticals Inc. has announced a registered direct offering expected to generate $6 million in gross proceeds, with nearly 5 million shares and short-term warrants involved. The company plans to use the funds to support the commercial launch of LYMPHIR™, an FDA-approved immunotherapy for cutaneous T-cell lymphoma, alongside other corporate purposes. In another development, Citius Pharmaceuticals secured an additional $2 million from a separate stock offering, also aimed at supporting the launch of LYMPHIR™ and other general corporate purposes. Both offerings are managed by H.C. Wainwright & Co. and are part of a shelf registration statement filed with the SEC.
Additionally, Citius Oncology, a subsidiary of Citius Pharmaceuticals, entered into a distribution services agreement with Cardinal Health to facilitate the U.S. commercial launch of LYMPHIR™. This strategic partnership is expected to enhance the availability and delivery of the immunotherapy treatment. Leonard Mazur, CEO of Citius Pharmaceuticals, emphasized the importance of Cardinal Health’s distribution expertise in ensuring efficient access to LYMPHIR™. These developments highlight Citius Pharmaceuticals’ active efforts to bring their new immunotherapy to market.
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