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 positive outcomes from a Data Monitoring Committee (DMC) meeting regarding its Mino-Lok phase 3 trial. The DMC found no safety signals and recommended continuing the trial without modifications. Despite challenges in patient recruitment during the COVID-19 pandemic, the company is nearing the late stage of the pivotal study. CEO Myron Holubiak expressed confidence in Mino-Lok's safety and efficacy, highlighting the dedication of study investigators amidst challenges.
Citius Pharmaceuticals, Inc. (CTXR) has announced significant milestones for its antibiotic lock solution, Mino-Lok, designed for treating central line-associated bloodstream infections. The company has manufactured three registration lots for the New Drug Application (NDA) and placed them on stability at ICH conditions. Additionally, an exclusive synthesis process for EDTA has been developed. CEO Myron Holubiak emphasized the uniqueness of Mino-Lok, which includes three active drug substances. Citius aims to commence commercial manufacturing following the completion of a Phase 3 clinical trial and FDA approval.
Citius Pharmaceuticals (Nasdaq: CTXR) has filed an amendment to the Mino-Lok phase 3 protocol to improve clinical trial record-keeping amid COVID-19. This adjustment aims to address challenges faced in the ICU due to restricted personal visits. The company remains committed to collaborating with Principle Investigators for effective trial management. CEO Myron Holubiak expressed optimism about ongoing trials despite significant hurdles and anticipates a Drug Monitoring Committee meeting at the end of the month.
Citius Pharmaceuticals (Nasdaq: CTXR) announced its presentation at the H.C. Wainwright 22nd Annual Global Investment Conference, scheduled for September 14-16, 2020. Chairman Leonard Mazur will present on September 15 at 11:00 a.m. ET, discussing the company’s recent expansion in intellectual property related to Mino-Wrap and plans to address acute respiratory distress syndrome (ARDS) related to COVID-19. Additionally, updates on Mino-Lok® will be provided, focusing on catheter-related bloodstream infections. Virtual one-on-one investor meetings will also be conducted.
Citius Pharmaceuticals (Nasdaq: CTXR) will present at the 12th annual LD Micro LD 500 conference on September 1 at 11:00 AM ET. Chairman Leonard Mazur will provide updates on the company's product developments, including treatments for acute respiratory distress syndrome related to COVID-19. This virtual event, accessible to all, runs from September 1 to September 4. This marks a significant opportunity for investors to gain insights into Citius’s strategic direction and product pipeline.
Citius Pharmaceuticals (CTXR) has expanded its intellectual property related to Mino-Wrap, a novel product aimed at reducing post-mastectomy infections involving tissue expanders. The USPTO has granted patent 10,434,221 B2, enhancing the design and application of Mino-Wrap under a global license agreement with MD Anderson Cancer Center. Approximately 100,000 U.S. patients undergo breast reconstruction annually, with infection rates for tissue expanders ranging from 2.5% to 24%. Mino-Wrap aims to significantly decrease this infection risk, potentially improving patient outcomes and reducing hospitalization.
Citius Pharmaceuticals (Nasdaq: CTXR) announced its participation in the MoneyShow Las Vegas Virtual Expo from August 18 to 20, 2020. The company's presentation is scheduled for August 19 at 4:50 PM ET, led by Chairman Leonard Mazur. Key topics include the recent $9.6 million public stock offering and a briefing to the FDA regarding Mino-Wrap, aimed at reducing post-operative infections. Investors can register for the event to access the live webcast.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) announced the successful closing of its public offering, selling 9,159,524 common shares at $1.05 each, including an option for the underwriter to purchase an additional 1,194,720 shares. The offering generated approximately $9.6 million in gross proceeds, which will be used for general corporate purposes, notably for clinical trials related to Mino-Lok and Halo-Lido, among other product development initiatives. This move reflects Citius's strategy to enhance its critical care product portfolio.
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.
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