Welcome to our dedicated page for Citius Pharmaceuticals Common news (Ticker: CTXR), a resource for investors and traders seeking the latest updates and insights on Citius Pharmaceuticals Common 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 (Nasdaq: CTXR) announced an increased public offering of 7,964,804 shares at $1.05 per share, anticipated to close on August 10, 2020. The offering is projected to generate gross proceeds of approximately $8.4 million, which will fund general corporate purposes, including its Phase 3 clinical trial for Mino-Lok® and the development of Halo-Lido cream. H.C. Wainwright & Co. is the sole underwriter, with a 30-day option for an additional 1,194,720 shares.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) has entered into an underwriting agreement with H.C. Wainwright & Co. for a public offering of 5,714,286 shares at $1.05 each, projected to close on or about August 10, 2020. This offering is expected to yield approximately $6.0 million before fees. A 30-day option allows the underwriter to purchase an additional 857,142 shares. Proceeds will support general corporate purposes, including clinical trials for Mino-Lok and Halo-Lido, and other development initiatives.
Citius Pharmaceuticals (NASDAQ: CTXR) has announced advancements in its product Mino-Wrap, aimed at reducing post-operative infections in breast reconstructive surgeries. The company has submitted a briefing package to the FDA, including pre-clinical data and a clinical development plan. Mino-Wrap is a gel-based wrap containing minocycline and rifampin, meant to protect tissue expanders from infections. With infection rates between 2.5% and 24%, Mino-Wrap aims to minimize complications that could delay cancer treatment. Citius is also collaborating with MD Anderson Cancer Center on this initiative.
Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) has established the Citius ARDS Scientific Advisory Board to guide the development of its induced mesenchymal stem cells (iMSCs) for treating Acute Respiratory Distress Syndrome (ARDS), especially in COVID-19 patients. The board comprises experts like Dr. Michael A. Matthay, Dr. Mitchell M. Levy, and Dr. Lorraine B. Ware, all recognized leaders in critical care and clinical trials. CEO Myron Holubiak expressed confidence in their expertise to enhance clinical trial design and execution for iMSC therapy.
Citius Pharmaceuticals (Nasdaq: CTXR) announced its participation in the MoneyShow Accredited Investor Virtual Event from July 22-24, 2020. Chairman Leonard Mazur will provide updates on the company's developmental products during a live presentation scheduled for 10:40 AM ET on July 22. Attendees can interact with the company in real-time, and an archived webcast will be available post-event. Interested investors must register for the event at the provided link.
On July 14, 2020, Citius Pharmaceuticals (CTXR) announced the appointment of Myron S. Czuczman, M.D., as Chief Medical Officer and Executive Vice President. Dr. Czuczman, previously at Celgene, is expected to enhance Citius's development programs, particularly for iPSC-derived mesenchymal stem cell therapy targeting ARDS related to COVID-19. This appointment comes as the company advances Phase 3 trials for Mino-Lok® and prepares an IND for Mino-Wrap. Citius focuses on critical care pharmaceuticals, especially anti-infectives and cancer treatments.
Citius Pharmaceuticals (NASDAQ: CTXR) announced on July 10, 2020, that it has regained compliance with NASDAQ's minimum bid price requirements, allowing it to remain listed on the exchange. This compliance closure is significant for the company as it continues its focus on developing critical care and cancer treatment products. Citius specializes in proprietary formulations of previously-approved drugs, targeting unmet medical needs while mitigating development risks.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) announced that its CEO, Myron Holubiak, will be featured on TD Ameritrade Network's The Watch List on June 30, 2020, at 1:20 PM ET. The show will involve discussions on market-moving topics with industry experts. Holubiak has a strong background in pharmaceutical management, previously serving as president of Roche Laboratories. Citius focuses on critical care pharmaceutical products, including therapies for acute respiratory distress syndrome (ARDS), which affects many COVID-19 patients annually.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) announced that the FDA has provided feedback on its pre-investigational new drug (PIND) application for its induced mesenchymal stem cells (iMSCs) aimed at treating acute respiratory distress syndrome (ARDS) in COVID-19 patients. The FDA suggested that Citius could apply for fast track designation and outlined the chemistry, manufacturing, and control (CMC) requirements necessary for upcoming trials. The company plans to initiate an Investigational New Drug (IND) application under the Coronavirus Treatment Acceleration Program (CTAP) following the FDA's guidance.
Citius Pharmaceuticals (Nasdaq: CTXR) announced that CEO Myron Holubiak will present at the Life Sciences Investor Forum on June 25, 2020, at 11:00 AM ET. The presentation will provide updates on the Company’s ongoing Phase 3 trial for Mino-Lok® and the potential licensing of a novel stem cell therapy for ARDS in COVID-19 patients. Investors can participate and ask questions during the event, which will also be available via archived webcast.
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