- FDA-approved LYMPHIR(TM) provides commercial-stage exposure to the oncology market.
- LYMPHIR(TM) generated $5.6 million in net revenue during the first six months of fiscal 2026 following its December 2025 commercial launch.
- Late-stage pipeline includes Mino-Lok(R), which met the primary and secondary endpoints of its pivotal Phase 3 trial.
- Diversified development portfolio targets critical-care indications with significant unmet medical needs.
- Halo-Lido could potentially become the first FDA-approved prescription product for the treatment of hemorrhoids in the United States.
- Stem cell platform provides an additional development opportunity targeting acute respiratory distress syndrome.
- Experienced leadership team has extensive pharmaceutical development, commercialization, sales, marketing and business development experience.
Citius Pharmaceuticals (NASDAQ: CTXR) is a biopharmaceutical company focused on developing and commercializing first-in-class critical care products. The company has built a diversified portfolio spanning oncology, anti-infectives in adjunct cancer care, stem cell therapy and prescription products, with a strategy centered on assets that address significant unmet medical needs and offer differentiated commercial opportunities.
Citius has progressed from a development-stage biotechnology company toward commercialization through LYMPHIR(TM) (denileukin diftitox-cxdl), an FDA-approved targeted immunotherapy for adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (“CTCL”) after at least one prior systemic therapy. LYMPHIR(TM) was commercially launched in December 2025 through Citius Oncology, Inc. (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals.
During the first six months of fiscal 2026, which included four months of commercial sales, LYMPHIR(TM) generated $5.6 million in net product revenue with gross margins of approximately 80%. Citius also reported that payer coverage represented nearly 100% of covered commercial lives and 83% of targeted accounts had achieved formulary inclusion or were under active review as of May 2026.
LYMPHIR(TM)
LYMPHIR(TM) is a targeted immunotherapy approved by the U.S. Food and Drug Administration in August 2024 for the treatment of adults with relapsed or refractory Stage I-III CTCL after at least one prior systemic therapy. CTCL is a rare form of non-Hodgkin lymphoma that primarily affects the skin. LYMPHIR(TM) is an engineered fusion protein that combines interleukin-2 and diphtheria toxin and is designed to target cells expressing IL-2 receptors.
Commercial distribution began in December 2025. In addition to establishing broad payer coverage in the United States, Citius Oncology announced an initial shipment of LYMPHIR(TM) to Europe in April 2026. The company has also reported repeat orders from initial accounts as it works to expand physician engagement and market penetration.
Beyond its currently approved CTCL indication, Citius is exploring the potential of LYMPHIR(TM) in additional oncology settings. Investigator-initiated studies have evaluated LYMPHIR(TM) in combination with pembrolizumab in recurrent or refractory gynecologic cancers and prior to commercial CD19-directed CAR-T therapy in patients with high-risk relapsed or refractory diffuse large B-cell lymphoma. Citius reported positive topline results from both Phase 1 studies in fiscal 2026.
Mino-Lok(R)
Mino-Lok(R) is Citius Pharmaceuticals’ late-stage antibiotic lock solution designed to salvage central venous catheters in patients with catheter-related bloodstream infections (“CRBSIs”) and central line-associated bloodstream infections (“CLABSIs”). These infections can be particularly serious in cancer and hemodialysis patients who depend on central venous catheters for treatment.
Rather than removing and replacing an infected catheter, Mino-Lok(R) is designed to eradicate infection while preserving the existing catheter. Citius notes that catheter removal and reinsertion can carry complication risks including pneumothorax, arterial puncture and catheter misplacement. There currently are no FDA-approved therapies specifically indicated to salvage infected central venous catheters.
A completed multicenter Phase 3 pivotal superiority trial met its primary and secondary endpoints. Mino-Lok(R) has also received Qualified Infectious Disease Product (“QIDP”) and Fast Track designations from the FDA, and Citius holds worldwide rights to the therapy through a license from The University of Texas MD Anderson Cancer Center. Following a Type C meeting with the FDA, the company reported receiving guidance outlining a pathway to support a future New Drug Application submission.
Citius identifies Mino-Lok(R) as a potentially significant commercial opportunity. Company investor materials estimate worldwide sales potential of approximately $1.8 billion.
Halo-Lido
Halo-Lido, also known as CITI-002, is a proprietary topical formulation combining halobetasol and lidocaine for the symptomatic treatment of hemorrhoids. The product candidate is designed to provide both anti-inflammatory and anesthetic relief.
Citius estimates that approximately 10 million people in the United States report hemorrhoid symptoms annually. Despite widespread use of prescription and over-the-counter treatments, the company notes that there currently are no FDA-approved prescription products specifically for hemorrhoids. If approved, Citius believes Halo-Lido could become the first FDA-approved prescription product for the indication.
The company completed a Phase 2b study of Halo-Lido in 2023 and subsequently met with the FDA to discuss the next steps in its clinical development program.
Stem Cell Platform
Citius is also developing a stem cell platform based on induced pluripotent stem cell-derived mesenchymal stem cells (“i-MSCs”). The program is being evaluated as a potential therapy for acute respiratory distress syndrome (“ARDS”), including lung injury associated with sepsis.
In a proof-of-concept sheep model of sepsis-induced ARDS, interim results reported by Citius showed improvements in measures including oxygenation, systemic shock, pulmonary vascular injury and bacterial clearance compared with controls. The company has stated that additional studies with larger sample sizes are warranted and that data from the program are intended to inform the design and dosing of potential future human clinical trials.
Commercial and Development Strategy
Citius has structured its portfolio around products that management believes combine unmet medical need with differentiated commercial characteristics. The transition of LYMPHIR(TM) into commercial sales provides the company with a revenue-generating oncology asset while Mino-Lok(R), Halo-Lido and the stem cell platform provide additional potential development catalysts.
LYMPHIR(TM) generated $5.6 million in net product revenue during the six months ended March 31, 2026, compared with no product revenue in the prior-year period. Citius reported approximately 80% gross margins on those sales. The company also has begun expanding LYMPHIR(TM) beyond the U.S. market, including an initial shipment to Europe announced in April 2026.
Citius continues to engage with the FDA regarding Mino-Lok(R) and Halo-Lido while evaluating opportunities to expand LYMPHIR(TM) into additional oncology indications. This combination of an FDA-approved commercial product and multiple clinical-stage programs provides several potential paths for future development and value creation.
Leadership Team
Leonard Mazur, Co-Founder, Chief Executive Officer and Chairman, has approximately five decades of pharmaceutical, healthcare and entrepreneurial experience. He previously co-founded Akrimax Pharmaceuticals and Triax Pharmaceuticals and founded Genesis Pharmaceuticals, which he sold to Pierre Fabre in 2003. His career also includes sales, marketing and business development roles with Medicis Pharmaceutical, ICN Pharmaceuticals, Knoll Pharma and Cooper Laboratories.
Myron Holubiak, Co-Founder and Executive Vice Chairman, has extensive pharmaceutical and life sciences leadership experience. He previously served as president of Roche Laboratories and held multiple sales and marketing roles during a 19-year career with Roche. Holubiak also served as chairman of Bioscrip and co-founded Leonard-Meron Biosciences before its merger with Citius in 2016.
Citius’ leadership experience across drug development, commercialization, pharmaceutical sales and marketing, business development and capital allocation supports a strategy focused on advancing differentiated therapies from clinical development through commercialization. With LYMPHIR(TM) now generating commercial revenue and additional programs progressing through the regulatory and development process, the company is positioned around multiple potential catalysts across its critical-care and oncology portfolio.
About Citius Pharmaceuticals, Inc.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is a biopharmaceutical company advancing and commercializing first-in-class therapies for critical care indications. The company owns approximately 62% of Citius Oncology, which commercially launched LYMPHIR in December 2025 for adults with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (“CTCL”) following at least one prior systemic therapy. Citius Pharma’s late-stage portfolio also includes Mino-Lok(R), an antibiotic lock solution designed to preserve central venous catheters in patients with catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical treatment being developed for hemorrhoid relief. Mino-Lok(R) achieved the primary and secondary endpoints in its pivotal Phase 3 trial, while Halo-Lido completed a Phase 2b study, with both trials completed in 2023. Citius Pharma continues to work with the FDA to determine the regulatory and development path forward for both programs.
For more information about CTXR, visit https://www.citiuspharma.com/
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