CITIUS ONCOLOGY, INC. 8-K

What Happened

• On March 10, 2026, CITIUS ONCOLOGY, INC. (filed as an 8-K) announced positive topline results from a completed investigator-initiated Phase 1 trial run by University of Pittsburgh investigators.
• The study evaluated LYMPHIR™ (denileukin diftitox-cxdl) in combination with the PD‑1 inhibitor pembrolizumab (KEYTRUDA®) in patients with recurrent or refractory gynecologic cancers (including ovarian and endometrial cancers) and reported direct T‑regulatory (Treg) cell depletion activity.

Key Details

• Filing date: March 10, 2026 (Form 8-K, Item 8.01).
• Study type: Investigator-initiated Phase 1 clinical trial conducted by University of Pittsburgh investigators.
• Intervention: LYMPHIR™ (denileukin diftitox-cxdl) combined with pembrolizumab (KEYTRUDA®).
• Outcome reported: Positive topline results indicating direct Treg cell depletion activity; press release attached as Exhibit 99.1.

Why It Matters

• The filing documents observed biological activity (Treg depletion) for LYMPHIR in combination with a PD‑1 inhibitor, a finding that could inform Citius’ clinical development strategy for immuno-oncology combinations.
• The 8-K contains a press release but does not present detailed clinical data or financial impacts; investors should watch for follow-up disclosures with full data, study details, and any company guidance about next steps.