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, Inc. (Nasdaq: CTXR) announced its inclusion in the Russell 2000 Index effective June 28, 2021. This milestone is expected to enhance the company's visibility and attract a broader investment community. The Russell indexes are utilized by institutional investors for asset management and benchmark strategies. Citius focuses on developing first-in-class critical care products, including Mino-Lok®, currently in a Phase 3 trial for treating catheter-related infections. The company also aims to advance stem cell therapy for respiratory conditions.
Citius Pharmaceuticals (Nasdaq: CTXR) announced receiving the Best Poster Award at the ISCT 2021 Annual Meeting for their poster titled "Novel Induced-Mesenchymal Stem Cells (i-MSCs) Attenuate Severity of ARDS in Septic Sheep". Dr. Perenlei Enkhbaatar presented the findings, which highlighted significant improvements in clinical parameters for i-MSC treated animals. Citius is progressing its stem cell therapy for ARDS and has developed a cell bank to support future trials. The recognition underscores the company’s advancements and engagement in cell and gene therapy.
Citius Pharmaceuticals, Inc. (CTXR) announced its participation at the ISCT Annual Meeting on May 26-28, 2021, with a poster presentation on a study evaluating induced pluripotent stem cell-derived mesenchymal stem cells (i-MSCs) for acute lung injury. Interim results indicate promising safety and efficacy signals for i-MSCs in treating Acute Respiratory Distress Syndrome (ARDS), a serious condition with no FDA-approved therapies. The findings could pave the way for future clinical trials in ARDS patients.
Citius Pharmaceuticals (Nasdaq: CTXR) has appointed Ilanit Allen as Vice President of Corporate Communications and Investor Relations, effective immediately. Allen brings over 20 years of experience, having previously advised numerous life science companies. Under her leadership, the company aims to enhance financial communication and investor engagement, paving the way for potential growth with multiple milestones on the horizon. Andrew Scott will take on expanded responsibilities in business development while maintaining his role in investor relations.
Citius Pharmaceuticals, Inc. (CTXR) reported its fiscal Q2 2021 results, highlighting a strong balance sheet with $103.7 million in cash. The company raised approximately $96.5 million, extending its funding runway into 2023. Despite enrollment challenges in the Mino-Lok® Phase 3 trial due to COVID-19, they are on track for a Drug Monitoring Committee meeting and plan to file a New Drug Application in 2022. Citius is advancing several product candidates, including Halo-Lido and a novel stem cell therapy for ARDS, aiming to address significant medical needs.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) will participate in a fireside chat at the Gabelli Funds Virtual Microcap Symposium on May 18, 2021, at 10:30 am ET. CEO Myron Holubiak will discuss corporate strategy and key pipeline assets, including Mino-Lok®, an advanced treatment for catheter-related bloodstream infections, and NC i-MSC, a novel stem cell therapy for Acute Respiratory Distress Syndrome (ARDS), worsening due to COVID-19. Mino-Lok® is in a Phase 3 trial and has received Fast Track designation from the FDA. For registration, visit the event website.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) announced participation in the Benzinga Global Small Cap Conference on May 13-14, 2021. CEO Myron Holubiak will present on May 13 at 1:50 p.m. ET, focusing on the company's pipeline strategy, particularly a novel stem-cell program for treating Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19. This condition currently lacks FDA-approved therapeutic options. Additionally, Citius's Mino-Lok® is undergoing a Phase 3 trial for catheter-related bloodstream infections.
Citius Pharmaceuticals (Nasdaq: CTXR) provided updates on its Mino-Lok® Phase 3 trial during a recent webinar, highlighting the growing interest from the clinical community. Mino-Lok is an antibiotic lock therapy aimed at salvaging central venous catheters (CVCs) in patients with catheter-related bloodstream infections (CRBSIs). Currently, no FDA-approved therapies exist for this purpose. The company believes that Mino-Lok could set a new standard in treating CRBSIs, emphasizing its potential to penetrate biofilms and maintain CVC access. The FDA has granted Mino-Lok Fast Track designation.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) announced that its President and CEO, Myron Holubiak, participated in a Benzinga interview discussing the company's product pipeline, Covid-19 impact, and future milestones. The company focuses on critical care products, particularly in anti-infective treatments and stem cell therapy. Notably, its lead product, Mino-Lok®, is in a Phase III trial and has received Fast Track designation by the FDA. The interview is available on the Citius corporate website.
Citius Pharmaceuticals will participate in the Benzinga Biotech Small Cap Conference on March 24-25, 2021, where Executive Chairman Leonard Mazur will discuss the Phase 3 trial of Mino-Lok®, an antibiotic solution for catheter-related bloodstream infections. The trial is progressing as planned, with full enrollment expected this year. The U.S. market opportunity for Mino-Lok® is projected at $750 million, with a worldwide potential of $1.5 billion. Investors can register for the conference via the provided event website.
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