On August 5, 2026 Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), an oncology-focused biopharmaceutical company and majority-owned subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), reported an update on the expanding base of institutions ordering LYMPHIR (denileukin diftitox-cxdl) through wholesalers, continued formulary progress at priority U.S. treatment centers, and other key indicators supporting the product’s commercial launch.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"Our commercial progress is reflected in two closely connected measures: growth in the number of institutions ordering LYMPHIR and continued expansion of the formulary approvals that enable additional institutions to begin ordering the product and treating patients," said Leonard Mazur, Chairman and Chief Executive Officer of Citius Oncology. "I am pleased to report that the number of new institutions ordering LYMPHIR rose, total institutional vial orders increased, formulary reviews and approvals grew, and wholesalers are reordering LYMPHIR to reflect this growth. Formulary inclusion is a key gateway to institutional ordering and patient access. The success of our targeted launch, so far, was accomplished by a small yet focused internal launch team. Together with our recently expanded commercial and medical affairs teams, we believe Citius Oncology is well positioned to broaden engagement with over 250 priority treatment centers, support continued adoption, and accelerate topline growth through the balance of the year."
LYMPHIR is now available in 42 institutions including academic oncology centers, leading National Comprehensive Cancer Network (NCCN) institutions and community infusion centers. During the quarter ended June 30, 2026, the number of new institutions increased 78% compared with the prior quarter. Vials ordered by institutions from wholesalers rose 31% during the quarter. Subsequent to the quarter ended June 30, 2026, following an increase in both the number of ordering institutions and vial demand, orders from wholesalers have begun to reflect this incremental demand. Citius revenue is recognized when wholesale orders for LYMPHIR are placed and filled.
LYMPHIR’s growing institutional footprint consists of leading academic and cancer treatment centers with recognized CTCL expertise. Formulary inclusion is an important step in the commercial adoption process. Once approved, an institution can order the product through a nationwide wholesaler network and make the therapy available for prescribing to eligible adult patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL). Review times vary by institution and may range from several weeks to several months. Based on Company experience to date, institutions that add LYMPHIR to formulary have generally placed their first patient order within approximately two to six weeks. Citius Oncology anticipates more than 20 additional institutions during the current quarter, and is targeting formulary inclusion with 100 priority institutions by year-end.
The Company continues to engage leading CTCL experts through scientific exchange and educational initiatives designed to increase understanding of LYMPHIR’s clinical profile and support institutional evaluation of the therapy. At the Sixth World Congress of Cutaneous Lymphomas in Montreal, the Company met with many U.S. and international CTCL key opinion leaders. The expanded medical affairs team is expected to increase the frequency and breadth of the Company’s scientific engagement with the CTCL community.
According to Company tracking, LYMPHIR has secured near-universal payer coverage. Formulary inclusion and payer coverage address complementary requirements for market access. Together, these indicators reflect continued progress in building LYMPHIR’s commercial foundation.
About LYMPHIR (denileukin diftitox-cxdl)
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 (DT) 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 DT fragment is cleaved and the free DT fragments inhibit protein synthesis, resulting in cell death. Denileukin diftitox-cxdl demonstrated the ability to deplete immunosuppressive regulatory T lymphocytes (Tregs) and antitumor activity through a direct cytocidal action on IL-2R-expressing tumors.
In 2021, reformulated denileukin diftitox received regulatory approval in Japan for the treatment of relapsed or refractory CTCL and peripheral T-cell lymphoma (PTCL). Subsequently, in 2021, Citius acquired an exclusive license with rights to develop and commercialize reformulated denileukin diftitox in all markets except for India, Japan and certain parts of Asia. LYMPHIR (denileukin diftitox-cxdl) was approved by the FDA and subsequently launched in the U.S. in December 2025.
(Press release, Citius Pharmaceuticals, AUG 5, 2026, View Source [SID1234669721])