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, Inc. (Nasdaq: CTXR) is a biopharmaceutical company focused on first-in-class critical care products and holds a majority interest in Citius Oncology, Inc. News about CTXR often centers on regulatory milestones, clinical progress, and financing activities that support the development and commercialization of its therapies.
Recent company communications emphasize the FDA approval of LYMPHIR (denileukin diftitox-cxdl) for adult patients with relapsed or refractory Stage I–III cutaneous T-cell lymphoma after at least one prior systemic therapy, and the subsequent U.S. commercial launch executed by Citius Oncology. CTXR news also highlights the late-stage status of Mino-Lok, a catheter lock solution for catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for hemorrhoid relief, along with completed pivotal and Phase 2b trials.
Investors following CTXR can expect updates on capital raises such as registered direct offerings and warrant issuances, which the company states are intended to fund the commercial launch of LYMPHIR, regulatory and milestone payments, and broader development initiatives. Filings and press releases also describe ongoing engagement with the FDA regarding next steps for Mino-Lok and Halo-Lido.
This news feed aggregates press releases, regulatory disclosures, and other public announcements related to Citius Pharmaceuticals and its majority-owned oncology subsidiary. For those tracking CTXR, it provides a centralized view of developments across oncology, critical care, clinical trials, and corporate finance. Regular review of this page can help readers monitor how Citius Pharmaceuticals advances its portfolio and supports the commercialization of LYMPHIR through Citius Oncology.
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.
Citius Pharmaceuticals (Nasdaq: CTXR) announced a registered direct offering to sell 3,973,510 shares (or pre-funded warrants) and accompanying common warrants to buy up to 3,973,510 shares at a purchase price of $1.51 per share, generating approximately $6.0 million in gross proceeds before fees. The common warrants carry a $1.40 exercise price, are exercisable immediately, and expire five years from the initial exercise date. Closing is expected on or about October 21, 2025, subject to customary conditions, with H.C. Wainwright acting as exclusive placement agent. Net proceeds are planned to support the commercial launch of LYMPHIR, product development, milestone and regulatory payments, and general corporate purposes.
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