Welcome to our dedicated page for Citius Pharmaceuticals news (Ticker: CTXR), a resource for investors and traders seeking the latest updates and insights on Citius Pharmaceuticals stock.
Citius Pharmaceuticals reports developments across its critical care and targeted oncology business, including activity at majority-owned subsidiary Citius Oncology. The company’s recurring updates center on LYMPHIR (denileukin diftitox-cxdl), an engineered IL-2 diphtheria toxin fusion protein approved for adults with relapsed or refractory Stage I–III cutaneous T-cell lymphoma after at least one prior systemic therapy.
Company news also covers LYMPHIR commercialization, U.S. launch progress, international access through Named Patient Programs, and investigator-initiated oncology studies involving gynecologic cancers and diffuse large B-cell lymphoma. Capital updates include registered direct offerings, warrant issuances, non-dilutive funding and other financing actions that support product commercialization and development programs.
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 Pharmaceuticals (Nasdaq: CTXR) closed a registered direct offering priced at‑the‑market on Oct 21, 2025, issuing 3,973,510 shares (or pre‑funded warrants) plus accompanying common warrants at a purchase price of $1.51 per share/pre‑funded warrant, for aggregate gross proceeds of approximately $6.0 million.
The common warrants are exercisable immediately at $1.40 per share and expire five years from initial exercise. H.C. Wainwright acted as exclusive placement agent. Net proceeds are intended to support the commercial launch of LYMPHIR, related milestone/regulatory payments, development of product candidates, and general corporate purposes. Securities were offered under shelf registration File No. 333-277319.