Welcome to our dedicated page for Citius Oncology news (Ticker: CTOR), a resource for investors and traders seeking the latest updates and insights on Citius Oncology stock.
Citius Oncology, Inc. reports developments tied to its oncology-focused biopharmaceutical business and the commercialization of LYMPHIR™ (denileukin diftitox-cxdl). The company is a majority-owned subsidiary of Citius Pharmaceuticals and develops targeted oncology therapies. LYMPHIR is FDA approved for adults with relapsed or refractory Stage I–III cutaneous T-cell lymphoma who have received at least one prior systemic therapy.
Recurring CTOR news includes U.S. launch updates, initial revenue and operating results, institutional adoption, payer coverage, international distribution through regional partners and Named Patient Programs, and investigator-led clinical studies involving LYMPHIR in additional oncology settings. Company updates also cover medical-affairs engagement, material agreements, shareholder voting matters, capital-structure disclosures, governance matters, and clinical or regulatory disclosures.
Citius Oncology (NASDAQ: CTOR) entered an exclusive distribution agreement with Uniphar to expand access to LYMPHIR™ (denileukin diftitox-cxdl) in designated territories across Western and Eastern Europe via country-specific managed access programs.
Uniphar will manage market access and distribution where permitted by local law; Citius Oncology will supply finished product and provide ongoing support. LYMPHIR is not approved for commercial use outside the United States and will be provided only through managed access programs, which do not constitute marketing authorization.
Citius Oncology (Nasdaq: CTOR) reported fiscal 2025 results and a business update following the U.S. commercial launch of LYMPHIR in December 2025 for relapsed/refractory Stage I–III CTCL after ≥1 prior systemic therapy. The company closed $36M in strategic financings (three offerings in July, Sept, Dec 2025) and received a $1M note from parent Citius Pharma to support commercialization. Cash was $3.9M as of Sept 30, 2025. FY25 R&D was $6.4M, G&A $8.8M, stock-based comp $8.3M, and net loss was $24.8M (‑$0.34/share). Company announced U.S. wholesaler agreements, 19-market named patient programs, an AI commercial collaboration, and preliminary combo trial results.
Citius Oncology (NASDAQ: CTOR) launched LYMPHIR (denileukin diftitox-cxdl) in the U.S. in December 2025 after FDA approval for adult patients with relapsed or refractory Stage I-III CTCL following at least one prior systemic therapy. The company secured distribution agreements with three major U.S. wholesalers, access in 19 international markets via named patient programs, an NCCN Category 2A recommendation, and a permanent HCPCS J-code (J9161). Production is sufficient for up to 18 months estimated demand. Fiscal 2025 cash was $4.3M; net loss was $39.7M. The company raised approximately $61M in gross proceeds from financings.
Citius Oncology (Nasdaq: CTOR) closed a concurrent registered direct offering and private placement priced at-the-market under Nasdaq rules on Dec 10, 2025, generating approximately $18 million in gross proceeds.
The transactions sold 1,284,404 registered shares and issued unregistered warrants to buy 1,284,404 shares at an exercise price of $1.09, and sold 15,229,358 private placement shares (or pre-funded warrants) with warrants for 15,229,358 shares at $1.09. Warrants become exercisable upon stockholder approval and expire five years after approval.
The company amended existing warrants covering 11,961,040 shares to reduce exercise prices to $1.09. Net proceeds are intended to support the commercial launch of LYMPHIR and for working capital.
Citius Oncology (Nasdaq: CTOR) announced a concurrent registered direct offering and private placement expected to raise approximately $18 million gross, with closings on or about December 10, 2025. The transactions include the sale of 1,284,404 shares in the registered direct and 15,229,358 shares (or pre-funded warrants) in the private placement at $1.09 per share, plus accompanying warrants exercisable upon stockholder approval and expiring five years after approval.
The company said net proceeds will support the commercial launch of LYMPHIR and general corporate purposes; H.C. Wainwright is sole placement agent. The company also agreed to amend existing warrants covering 11,961,040 shares to a reduced exercise price of $1.09, effective on closing.
Citius Oncology (Nasdaq: CTOR) announced on December 4, 2025 an exclusive distribution agreement with Er-Kim to commercialize LYMPHIR (denileukin diftitox-cxdl) in Turkey and Gulf Cooperation Council countries: Bahrain, Qatar, Oman, Kuwait, Saudi Arabia, and the United Arab Emirates.
The partnership expands LYMPHIR international availability to 19 markets outside the U.S., using Named Patient Programs where permitted by local law. LYMPHIR is an FDA-approved IL-2 receptor-directed cytotoxin for adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma after at least one prior systemic therapy. Under the agreement, Er-Kim will handle sales, marketing and reimbursement while Citius Oncology supplies finished product and provides support.
Citius Oncology (Nasdaq: CTOR) announced the U.S. commercial launch of LYMPHIR™ (denileukin diftitox-cxdl) on Dec 1, 2025 for adult patients with relapsed or refractory Stage I–III cutaneous T‑cell lymphoma (CTCL) after at least one prior systemic therapy.
FDA approval was supported by Pivotal Study 302 showing an ORR 36.2%, 84% of evaluable patients with reduced skin tumor burden, and a median time to response 1.4 months. LYMPHIR has a permanent J‑code (J9161) effective Apr 1, 2025 and a Category 2A recommendation in NCCN Guidelines. U.S. distribution is via specialty distributors and commercial support programs; international rights exclude India, Japan, and parts of Asia.
Citius Oncology (Nasdaq: CTOR) will exhibit at the 67th American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando, Florida, December 6–9, 2025, at Booth #265.
The company will present LYMPHIR (denileukin diftitox-cxdl), an IL-2 receptor-directed fusion protein approved by the FDA for adult patients with relapsed or refractory Stage I–III cutaneous T-cell lymphoma after at least one prior systemic therapy. Company representatives will be available throughout the meeting to engage with physicians, researchers and CTCL stakeholders. The press release notes the LYMPHIR launch is on track for Q4 2025.
Citius Oncology (Nasdaq: CTOR) announced a deeper collaboration with Verix to integrate the Verix Tovana AI platform into the commercial launch of LYMPHIR (denileukin diftitox-cxdl). LYMPHIR is FDA approved for adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma after ≥1 prior systemic therapy and is expected to be commercially available in the U.S. in Q4 2025.
The initiative builds on distribution partnerships, a permanent reimbursement code (J9161), and inclusion in the NCCN Guidelines. Verix Tovana will use real-world claims, analytics, and machine learning to refine HCP targeting, prioritize prescriber engagement, and support real-time field execution to accelerate launch and market penetration.
Citius Oncology (Nasdaq: CTOR) signed a U.S. distribution services agreement with McKesson (NYSE: MCK) to serve as an authorized distributor of record for LYMPHIR (denileukin diftitox-cxdl).
LYMPHIR is FDA approved for adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma after at least one prior systemic therapy. The McKesson agreement completes Citius Oncology's core U.S. distribution network with all three largest pharmaceutical wholesalers, supporting the planned commercial launch in Q4 2025. The company also cites inventory readiness, permanent J-code J9161, NCCN guideline inclusion, and provider and patient education resources as part of its commercialization preparations.