Citius Oncology Highlights Phase 1 Data in an Investigator-Initiated Study of LYMPHIR® (denileukin diftitox-cxdl) in Combination with Pembrolizumab in Recurrent or Refractory Gynecologic Malignancies

Investigator-initiated study data presented May 30, 2026, at the American Society of Clinical Oncology (ASCO) Annual Meeting demonstrated durable responses and manageable tolerability in heavily pre-treated patients 20.5 months of median progression-free survival observed among 48% of efficacy-evaluable patients achieving clinical benefit (10 of 21) Responses were observed in patients previously treated with immune checkpoint inhibitors, including a 33% objective response rate in patients with relapsed or refractory endometrial cancer CRANFORD, N.J., June 1, 2026 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), an oncology‑focused biopharmaceutical company and majority‑owned subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today highlighted Phase 1 clinical data presented May 30, 2026, at the American Society of Clinical Oncology (ASCO) Annual Meeting evaluating LYMPHIR (denileukin diftitox-cxdl) in combination with pembrolizumab in patients with recurrent or refractory gynecologic malignancies.

PRNewsWire • Jun 1, 2026

Citius Oncology Announces Presentation of LYMPHIR® Phase 1 Combination Study Data at the 2026 American Society of Clinical Oncology Annual Meeting

24% Objective Response Rate, with an average of 21.1 month Duration of Response in responders, and favorable safety profile signals potential of LYMPHIR to augment immune checkpoint inhibitor efficacy Investigator-initiated study of LYMPHIR in combination with pembrolizumab to be presented during immunotherapy session, highlighting potential role of LYMPHIR beyond CTCL CRANFORD, N.J., May 26, 2026 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), an oncology‑focused biopharmaceutical company and majority‑owned subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today announced that University of Pittsburgh Medical Center's investigator-initiated trial evaluating LYMPHIR (denileukin diftitox-cxdl) in combination with the PD-1 immune checkpoint inhibitor pembrolizumab (KEYTRUDA®) has been selected for poster presentation at the American Society of Clinical Oncology Annual Meeting (ASCO), taking place May 29 – June 2, 2026, in Chicago, Illinois.

PRNewsWire • May 26, 2026

Citius Oncology, Inc. Reports Fiscal Second Quarter 2026 Financial Results and Provides Business Update

$5.6 million in net revenue for the first half of fiscal 2026 as LYMPHIR ® launch progresses Up to $36.5 million in debt and equity capital secured Broad payer coverage established with no reimbursement denials 83% of target accounts on formulary or in review CRANFORD, N.J., May 15, 2026 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology" or the "Company") (Nasdaq: CTOR), the oncology-focused subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today reported financial results for the fiscal second quarter ended March 31, 2026, and provided a business update.

PRNewsWire • May 15, 2026

Citius Pharmaceuticals, Inc. Reports Fiscal Second Quarter 2026 Financial Results and Provides Business Update

$5.6 Million in net revenue for the first half of fiscal 2026 from ongoing launch of LYMPHIR ® Citius Pharma raised $5 million in a registered direct offering; Citius Oncology secured up to $36.5 million in debt and equity financing Advanced patient access with payer coverage near 100% of commercial lives and 83% of LYMPHIR target accounts on formulary or in review CRANFORD, N.J., May 15, 2026 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius Pharma" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, today reported business and financial results for the fiscal second quarter ended March 31, 2026, and provided a business update, including progress at its majority-owned subsidiary, Citius Oncology, Inc. (Nasdaq: CTOR).

PRNewsWire • May 15, 2026

Citius Oncology, Inc. Secures Up to $36.5 Million in Debt and Equity Capital to Accelerate LYMPHIR® Commercialization

Avenue Capital Group to provide up to $25 Million via Senior Credit Facility with an initial $10 million tranche funded at closing; additional tranches subject to certain conditions Gross proceeds of approximately $11.5 million secured by a concurrent exercise of certain outstanding warrants held by single healthcare-focused institutional investor Financings to support ongoing commercial execution while preserving flexibility for future growth initiatives CRANFORD, N.J., May 5, 2026 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology" or the "Company") (Nasdaq: CTOR), a specialty biopharmaceutical company focused on the development and commercialization of novel targeted oncology therapies, today announced that it has entered into a senior secured term loan credit facility (the "Credit Facility") with Avenue Venture Opportunities Fund II, L.P.

PRNewsWire • May 6, 2026

Citius Oncology Ships First International Order of LYMPHIR™ to Europe

Order fulfilment expands international patient access to LYMPHIR following initial U.S. launch Distribution by regional partners through Named Patient Programs in specific international markets CRANFORD, N.J., April 29, 2026 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), an oncology‑focused biopharmaceutical company and majority‑owned subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today announced the initial shipment of LYMPHIR™ (denileukin diftitox-cxdl) to Europe through one of its regional distribution partners, marking an important milestone in expanding access to the therapy for patients outside the United States.

PRNewsWire • Apr 29, 2026

Citius Oncology Provides Commercial Update on LYMPHIR™ Launch Highlighting Early Adoption and Expanding Clinical Development

Broad institutional uptake among leading cancer centers and payer coverage supports early prescribing momentum and clinical integration CRANFORD, N.J., March 31, 2026 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), an oncology‑focused biopharmaceutical company and majority‑owned subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today provided a commercial update on the U.S. launch of LYMPHIR™ (denileukin diftitox-cxdl) for the treatment of cutaneous T-cell lymphoma (CTCL), highlighting continued adoption across leading oncology centers, broad payer coverage progress, and advancing investigator-led clinical studies.

PRNewsWire • Mar 31, 2026

Citius Oncology to Participate in USCLC Annual Workshop 2026, Highlighting LYMPHIR™ in Discussions with Leading Cutaneous Lymphoma Experts

Citius Oncology to meet with cutaneous T-cell lymphoma (CTCL) specialists as part of ongoing clinical engagement; one-on-one meetings available CRANFORD, N.J., March 24, 2026 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), an oncology‑focused biopharmaceutical company and majority‑owned subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today announced that members of its commercial and medical affairs teams will attend the USCLC Annual Workshop 2026.

PRNewsWire • Mar 24, 2026

Citius Oncology Announces Positive Topline Results from Investigator‑Initiated Phase 1 Study of LYMPHIR™ in Combination with Pembrolizumab in Relapsed or Refractory Gynecologic Cancers

Study data from patients with relapsed or refractory gynecologic cancers signals the potential of LYMPHIR to augment immune checkpoint inhibitor efficacy Topline data of University of Pittsburgh-led trial to be presented at an upcoming international cancer conference later this year CRANFORD, N.J., March 10, 2026 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), an oncology‑focused biopharmaceutical company and majority‑owned subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today announced positive topline results from a completed investigator‑initiated Phase 1 clinical trial conducted by University of Pittsburgh investigators.

PRNewsWire • Mar 10, 2026

Citius Oncology Announces Preliminary Topline Phase 1 Data from Study of LYMPHIR™ (E7777) Dosing Prior to Commercial CAR‑T Therapy in High‑Risk Diffuse Large B‑Cell Lymphoma

Topline data of investigator‑initiated study at the University of Minnesota and City of Hope demonstrates 86% overall response rate (OR), including 57% complete response (CR) and 29% partial response (PR) LYMPHIR was well-tolerated with no dose-limiting toxicities observed CRANFORD, N.J., March 4, 2026 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), an oncology‑focused biopharmaceutical company and majority‑owned subsidiary of Citius Pharmaceuticals, Inc. ("Citius Pharma") (Nasdaq: CTXR), today announced positive topline safety and efficacy results from an investigator‑initiated Phase 1 trial evaluating LYMPHIR™ (E7777, denileukin diftitox‑cxdl) administered prior to commercial CD19‑directed CAR‑T therapy in patients with high‑risk relapsed or refractory diffuse large B‑cell lymphoma (DLBCL).

PRNewsWire • Mar 4, 2026