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 specialty biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. Founded in 2007 and headquartered in Cranford, New Jersey, Citius focuses on providing innovative treatments in areas such as anti-infectives, oncology, and stem cell therapy.
The company's diversified pipeline includes several late-stage product candidates:
- Mino-Lok®: An antibiotic lock solution used to salvage infected catheters in patients with catheter-related bloodstream infections. This product is currently in pivotal Phase 3 clinical trials.
- Mino-Wrap®: A liquifying gel-based wrap designed to reduce tissue expander infections following breast reconstructive surgeries.
- Halo-Lido®: A topical corticosteroid-lidocaine formulation intended to provide anti-inflammatory and anesthetic relief for individuals suffering from hemorrhoids. Enrollment in its Phase 2b trial has been completed.
- LYMPHIR™ (denileukin diftitox): An IL-2-based immunotherapy for the treatment of cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL). The Biologics License Application (BLA) for LYMPHIR is currently under review by the FDA, with a PDUFA target action date set for August 13, 2024.
- NoveCite™: A mesenchymal stem cell therapy aimed at treating acute respiratory distress syndrome.
Recently, Citius has made significant advancements:
- Completed the Phase 3 trial recruitment for Mino-Lok.
- Resubmitted the BLA for LYMPHIR, addressing FDA comments with no safety or efficacy concerns noted.
- Announced a merger of its oncology subsidiary with TenX to form a publicly listed company, enhancing financial flexibility and potential value for stakeholders.
- Secured $2.4 million in non-dilutive capital through New Jersey’s Net Operating Loss (NOL) program.
Financially, as of March 31, 2024, Citius reported $12.6 million in cash and cash equivalents and has recently expanded its cash runway by successfully completing a $15 million registered direct offering. The company remains focused on the commercialization of LYMPHIR, completion of the Mino-Lok Phase 3 trial, and planning for the Phase 3 trial of Halo-Lido.
With a commitment to innovation and a strong pipeline, Citius Pharmaceuticals continues to strive towards providing effective treatments for critical care needs across various medical fields.
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.
Citius Pharmaceuticals announced a 1-for-25 reverse stock split effective November 25, 2024, with split-adjusted trading beginning November 26 under the symbol CTXR. The split aims to regain Nasdaq compliance by increasing the share price above the $1.00 minimum bid requirement. The action will reduce authorized shares from 400 million to 16 million, and outstanding shares from approximately 193 million to 7.7 million. No fractional shares will be issued, with rounding up to the nearest whole share. The split will also affect outstanding warrants and stock options, with proportionate adjustments to exercise prices.
Citius Pharmaceuticals (Nasdaq: CTXR) has closed a $3 million registered direct offering, selling 12,000,000 shares of common stock with accompanying warrants at $0.25 per share and warrant. The warrants are immediately exercisable at $0.25 per share and expire in five years. H.C. Wainwright & Co. served as the exclusive placement agent. The company plans to use the net proceeds for general corporate purposes, including pre-clinical and clinical development of product candidates, working capital, and capital expenditures.
Citius Pharmaceuticals (Nasdaq: CTXR) has announced a $3 million registered direct offering of 12,000,000 shares of common stock and accompanying warrants. The offering price is set at $0.25 per share and warrant, with warrants exercisable immediately at $0.25 per share and expiring in five years. H.C. Wainwright & Co is serving as the exclusive placement agent. The company plans to use the proceeds for general corporate purposes, including pre-clinical and clinical development of product candidates, working capital, and capital expenditures. The offering is expected to close around November 18, 2024.
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