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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.
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Citius Pharmaceuticals, Inc. (CTXR) secures $2.4 million in non-dilutive capital through New Jersey's NOL Program. The funding will support the advancement of their critical care product pipeline.
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Citius Pharmaceuticals, Inc. (CTXR) files Form S-3 shelf registration to replace expiring statement, aiming for continued development and commercialization of critical care products.
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Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) announces participation in two investor conferences with Chairman and CEO Leonard Mazur presenting at BIO CEO and Investor Conference and Sidoti Small-Cap Virtual Conference. Details of the presentations and registration information provided.
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Citius Pharmaceuticals, Inc. resubmitted LYMPHIR™ BLA to the FDA and completed Mino-Lok® Phase 3 trial enrollment. Financially, they reported $20.3 million in cash, with R&D expenses at $2.6 million and a net loss of $9.2 million for Q1 2024.
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Citius Pharmaceuticals, Inc. announces the resubmission of the BLA for LYMPHIR™ to the FDA for the treatment of CTCL, expecting FDA acceptance within 30 days.
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Citius Pharmaceuticals, Inc. announces the nomination of Robert J. Smith as an Independent Director to its Board of Directors, subject to shareholder approval at the Annual Shareholders' Meeting in March 2024. Mr. Smith, a seasoned pharmaceutical executive, has extensive experience with leading pharmaceutical companies, and his appointment is expected to bring valuable insights to Citius.
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Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) completes enrollment in pivotal Phase 3 trial for Mino-Lok, an antibiotic lock solution to salvage catheters in patients with catheter-related bloodstream infections. A total of 109 catheter failures were observed out of 241 enrolled patients. Topline data expected in 2Q 2024.
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Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) completes Mino-Lok® Pivotal Phase 3 trial enrollment, with topline data expected in 2Q 2024. LYMPHIR™ BLA resubmission on track for early 2024. The company reports fiscal full year 2023 business and financial results, highlighting progress in pipeline development, clinical trials, and merger activities. Financially, the company has $26.5 million in cash and cash equivalents, with R&D and G&A expenses detailed for the full year 2023.
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Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) to Present at Sidoti Micro-Cap Virtual Conference on November 15, 2023
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Citius Pharmaceuticals announces positive results from a preclinical study on LYMPHIR, showing that it enhances anti-tumor activity and improves overall survival when combined with anti-PD-1 treatment. Two Phase 1 trials are currently underway based on the study's findings.
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FAQ
What is the current stock price of Citius Pharmaceuticals Common (CTXR)?
The current stock price of Citius Pharmaceuticals Common (CTXR) is $3.71 as of January 8, 2025.
What is the market cap of Citius Pharmaceuticals Common (CTXR)?
The market cap of Citius Pharmaceuticals Common (CTXR) is approximately 29.7M.
What does Citius Pharmaceuticals Inc. specialize in?
Citius Pharmaceuticals Inc. specializes in developing and commercializing first-in-class critical care products, focusing on anti-infectives, oncology, and stem cell therapy.
What are some key products in Citius Pharmaceuticals' pipeline?
Key products include Mino-Lok (antibiotic lock solution), Mino-Wrap (gel-based wrap for infection reduction), Halo-Lido (corticosteroid-lidocaine topical for hemorrhoids), LYMPHIR (IL-2-based immunotherapy), and NoveCite (stem cell therapy).
What recent achievements has Citius Pharmaceuticals made?
Recent achievements include completing the Phase 3 trial recruitment for Mino-Lok, resubmitting the BLA for LYMPHIR with no safety or efficacy concerns, and securing $2.4 million in non-dilutive capital via New Jersey’s NOL program.
What is the financial condition of Citius Pharmaceuticals?
As of March 31, 2024, Citius Pharmaceuticals had $12.6 million in cash and cash equivalents. The company also completed a $15 million registered direct offering to extend its cash runway.
What is LYMPHIR and what stage is it in?
LYMPHIR is an IL-2-based immunotherapy for treating cutaneous T-cell lymphoma and peripheral T-cell lymphoma. The Biologics License Application (BLA) is currently under FDA review, with a PDUFA target action date of August 13, 2024.
What is the focus of Citius Pharmaceuticals in 2024?
In 2024, Citius Pharmaceuticals is focusing on the commercialization of LYMPHIR, completing the Phase 3 trial for Mino-Lok, and planning the Phase 3 trial for Halo-Lido.
Where is Citius Pharmaceuticals headquartered?
Citius Pharmaceuticals is headquartered in Cranford, New Jersey.
What are the financial projections for Citius Pharmaceuticals?
Citius expects to have sufficient funds to continue operations through December 2024, supported by recent capital raising activities.
What are the main therapeutic areas Citius Pharmaceuticals is targeting?
Citius targets anti-infectives, oncology treatments, and stem cell therapies.
Who is the current CEO of Citius Pharmaceuticals?
Leonard Mazur is the current Chairman and CEO of Citius Pharmaceuticals.
Citius Pharmaceuticals Inc. Common
Nasdaq:CTXR
CTXR Rankings
CTXR Stock Data
29.75M
7.23M
6.81%
13.17%
6.78%
Biotechnology
Pharmaceutical Preparations
United States of America
CRANFORD