Citius Pharmaceuticals (NASDAQ:CTXR) Chief Executive Officer Leonard Mazur outlined the company’s commercial progress with LYMPHIR, its FDA-approved treatment for cutaneous T-cell lymphoma, or CTCL, and provided updates on its broader pipeline during an H.C. Wainwright presentation.
Mazur said Citius operates alongside its subsidiary, Citius Oncology, which holds LYMPHIR. Citius Pharmaceuticals owns 71% of Citius Oncology, according to Mazur, and the companies share management services in an arrangement he said is intended to reduce operating expenses.
LYMPHIR Commercial Rollout
The company began shipping LYMPHIR to wholesalers at the end of December to establish distribution, Mazur said. He characterized the commercial rollout as early-stage, noting that Citius initially launched with two field employees before expanding its commercial organization.
According to Mazur, the company recently added 21 commercial representatives and eight medical science liaison representatives through EVERSANA, a pharmaceutical-services provider. The representatives are dedicated exclusively to Citius Oncology, though they are employed by EVERSANA, he said.
Mazur reported $7.1 million in LYMPHIR volume over the initial launch period and said 44 institutions had ordered the product from wholesalers. He also said 135 health plans now provide coverage, representing 100% of covered lives, according to the company’s assessment.
LYMPHIR orders increased from the quarter ended March 2026 through the quarter ended June 30, 2026, with July representing one of the company’s strongest months for vial orders, Mazur said. He said the company expects the expanded field team to have a more visible impact during the fourth calendar quarter of 2026 and first quarter of 2027.
The CTCL market is estimated by the company at approximately $400 million to $500 million. Mazur identified Pfizer’s ADCETRIS and Kyowa Kirin’s Poteligeo as promoted competitors, while noting that Bristol Myers Squibb’s Istodax is also available but not actively promoted, according to his presentation.
Mazur said Citius sees an advantage in the concentration of the CTCL market, with 60% of patients located in roughly 10 states. He added that all three major U.S. wholesalers carry LYMPHIR, and that the product’s hospital-based use means the company does not expect managed-care rebates. Even after a 10% royalty obligation, the company estimates a gross margin of approximately 77%.
Clinical and Development Programs
CTCL is a subgroup of non-Hodgkin’s lymphoma that can cause severe itching, painful skin lesions and disfigurement. Mazur said the disease affects approximately 3,000 people in the United States annually and is most commonly represented by mycosis fungoides, followed by Sézary syndrome.
In clinical data discussed during the presentation, Mazur said LYMPHIR produced a 36% objective response rate across 302 outcomes, with responses appearing within six weeks. He cited a response duration of about six and a half months and said 84% of patients experienced skin reduction.
The company is also monitoring investigator-initiated studies evaluating LYMPHIR in combination approaches outside its approved indication. At the University of Pittsburgh, an investigator is studying LYMPHIR with Merck’s KEYTRUDA in ovarian and endometrial cancers. Mazur said the study reported a 36% response rate, but emphasized that the company is evaluating the data to determine whether a Phase II follow-up could be warranted.
A separate investigator-initiated trial at the University of Minnesota is evaluating LYMPHIR in combination with CAR-T therapy, Mazur said.
Mino-Lok and Halo-Lido
Beyond oncology, Mazur said Citius is in extended discussions with the FDA regarding Mino-Lok, a Phase III-stage catheter lock solution intended to sterilize infected central venous catheters. The treatment contains minocycline, sodium EDTA and alcohol, and is designed to eliminate bacterial biofilm within a catheter without entering the patient’s bloodstream.
He said Mino-Lok could address an estimated 400,000 to 500,000 catheter infections annually and represents what the company views as a potential $1 billion U.S. opportunity, with a similar opportunity internationally.
Citius is also developing Halo-Lido, a combination of halobetasol and lidocaine for hemorrhoids. Mazur said the company believes the product could be differentiated because there is no FDA-approved prescription treatment for hemorrhoids. However, he said Citius would likely seek to out-license or sell the program after demonstrating efficacy because the product would target the primary-care market.
About Citius Pharmaceuticals (NASDAQ:CTXR)
Citius Pharmaceuticals, Inc (NASDAQ: CTXR) is a specialty pharmaceutical company focused on developing and commercializing products for underserved areas of healthcare. The company has historically concentrated on anti-infective therapies, oncology treatments and supportive-care products, with an emphasis on therapies that address significant unmet medical needs.
Citius’ lead programs have included Mino-Lok, an investigational antibiotic lock solution designed to help salvage infected central venous catheters by treating catheter-related bloodstream infections while preserving the catheter.
