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 Pharmaceuticals (CTXR) and its oncology subsidiary Citius Oncology (CTOR) announced their participation in the upcoming Jefferies Global Healthcare Conference in New York City from June 3-5, 2025. Chairman and CEO Leonard Mazur will deliver a presentation on Thursday, June 5, 2025, at 3:10 pm ET.
The presentation will be available via live webcast and archived for later viewing on the company's website. Additionally, Mr. Mazur will engage in one-on-one meetings with institutional investors during the conference. Interested investors can arrange meetings through their Jefferies representatives.
Citius Pharmaceuticals (NASDAQ: CTXR) has announced a $2 million registered direct offering of common stock. The company will issue 1,739,131 shares at a purchase price of $1.15 per share, with the option for pre-funded warrants. The offering, expected to close around April 2, 2025, is being facilitated by H.C. Wainwright & Co. as the exclusive placement agent.
The net proceeds, after deducting placement agent fees and offering expenses, will be used to support the commercial launch of LYMPHIR™ and general corporate purposes. The offering is being made through a shelf registration statement filed with the SEC on February 23, 2024, and declared effective on March 1, 2024.
Citius Pharmaceuticals (CTXR) reported its fiscal Q1 2025 results, highlighting preparations for the LYMPHIR commercial launch in H1 2025. The company secured a new J-code (J9161) for LYMPHIR, effective April 1, 2025, and reported promising preliminary results from an ongoing Phase I trial combining LYMPHIR with pembrolizumab.
Financial results showed cash and cash equivalents of $1.1 million as of December 31, 2024. The company reported a net loss of $10.3 million ($1.30 per share), compared to $9.2 million ($1.45 per share) in the prior year. R&D expenses decreased to $2.1 million from $2.6 million, while G&A expenses increased to $5.4 million from $3.7 million.
The company raised $6.5 million through offerings in late 2024 and early 2025, completed a 1-for-25 reverse stock split, and regained Nasdaq compliance.
Citius Pharmaceuticals and Citius Oncology announced that LYMPHIR™ (denileukin diftitox-cxdl) has received a permanent Healthcare Common Procedure Coding System (HCPCS) J-code (J9161) from the Centers for Medicare & Medicaid Services. The code will be effective April 1, 2025.
LYMPHIR is FDA-approved for treating adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. The permanent J-code will help streamline billing and reimbursement processes for healthcare providers administering LYMPHIR, facilitating access for patients with commercial and government insurance coverage.
Citius Pharmaceuticals (Nasdaq: CTXR) announced a registered direct offering priced at-the-market under Nasdaq rules. The company has entered into definitive agreements to sell 743,496 shares of its common stock along with warrants to purchase an equal number of shares. The purchase price is $4.035 per share and accompanying warrant.
The warrants have an exercise price of $3.91 per share, are exercisable immediately upon issuance, and will expire five years from the initial exercise date. The offering is expected to close around January 8, 2025, subject to customary closing conditions. H.C. Wainwright & Co. is acting as the exclusive placement agent for this offering.
The aggregate gross proceeds are anticipated to be approximately $3 million, before deducting placement agent fees and other expenses. Citius plans to use the net proceeds for general corporate purposes, including pre-clinical and clinical development, working capital, and capital expenditures.
The securities are being offered under a shelf registration statement filed with the SEC on February 23, 2024 and declared effective on March 1, 2024. The offering will be made by a prospectus and prospectus supplement available on the SEC's website.
Citius Pharmaceuticals and its subsidiary Citius Oncology announced preparations for the commercial launch of LYMPHIR™ in the first half of 2025. LYMPHIR, approved in August 2024, is an immunotherapy treatment for adults with relapsed or refractory cutaneous T-cell lymphoma (CTCL).
The companies have made significant progress in key launch areas including: securing commercial supply agreements and producing first-year launch supply; implementing healthcare provider education programs; working on reimbursement pathways; submitting for a unique J-code; securing inclusion in NCCN guidelines; developing patient assistance programs; and building a specialized sales team.
Management is also exploring additional growth opportunities through international licensing partnerships and potential expanded indications for LYMPHIR, including its use as a combination immunotherapy.
Citius Oncology (Nasdaq: CTOR), a majority-owned subsidiary of Citius Pharmaceuticals (Nasdaq: CTXR), has engaged Jefferies as its exclusive financial advisor to explore strategic alternatives for maximizing shareholder value. The company is considering various options including partnerships, joint ventures, mergers, acquisitions, and licensing transactions.
The announcement comes as Citius Oncology prepares to launch LYMPHIR™, their recently FDA-approved therapy for treating patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) who have undergone at least one prior systemic therapy.
The company has not established a specific timeline for this strategic review process and will only disclose developments if the Board of Directors approves a specific transaction or deems disclosure necessary. There is no guarantee that this process will result in any strategic transaction.
Citius Pharmaceuticals (CTXR) reported fiscal year 2024 results, highlighting key achievements including FDA approval of LYMPHIR™ for CTCL treatment and positive Phase 3 trial results for Mino-Lok®. The company reported cash and equivalents of $3.3 million as of September 30, 2024. Financial results show R&D expenses decreased to $11.9 million from $14.8 million, while G&A expenses increased to $18.2 million from $15.3 million. Net loss widened to $39.4 million ($5.97 per share) compared to $32.5 million ($5.57 per share) in 2023. The company completed merger of its oncology subsidiary to form Citius Oncology (CTOR) and plans LYMPHIR commercial launch in first half of 2025.
Citius Pharmaceuticals announced a productive Type C meeting with the FDA following the successful completion of their Phase 3 clinical trial for Mino-Lok®. The meeting focused on discussing clinical trial data and establishing a pathway for future New Drug Application (NDA) submission. The FDA provided clear and actionable guidance regarding the novel catheter lock solution designed to salvage central venous catheters in patients with bloodstream infections. The company reports that Mino-Lok® demonstrated compelling clinical outcomes in Phase 3, potentially offering an alternative to catheter removal that could reduce healthcare costs and improve patient outcomes.