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. (CTXR) delivers innovative therapies for critical care needs through its pipeline of novel oncology treatments and anti-infective solutions. This news hub provides investors and healthcare professionals with timely updates on clinical developments, regulatory milestones, and strategic initiatives shaping the company's progress.
Access verified information about CTXR's FDA interactions, trial results for therapies like LYMPHIR™ and Mino-Lok®, and partnership announcements. Our curated collection ensures you stay informed about material events without promotional bias, supporting data-driven decision-making in this specialized biopharmaceutical sector.
Key updates include progress reports on late-stage clinical programs, manufacturing expansions, and peer-reviewed research publications. All content undergoes strict verification to maintain compliance with financial disclosure standards while preserving accessibility for both medical and investment audiences.
Bookmark this page for streamlined tracking of CTXR's advancements in targeted immunotherapies and critical care innovations. Combine regular monitoring with professional financial advice to maintain perspective on the company's evolving market position.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) provided a business update for the six months ending June 30, 2021. The independent Data Monitoring Committee (DMC) recommended continuing the Phase 3 Mino-Lok® trial with no modifications, citing efficacy signals. The trial is expected to complete by late 2021 or early 2022, with an NDA submission to the FDA planned for 2022. The company raised $127.6 million in financing, with $16.9 million from warrant exercises. Citius aims to leverage these resources to expedite trial completion and advance additional novel products.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) announced that the independent Data Monitoring Committee (DMC) has recommended continuing the Mino-Lok® Phase 3 Pivotal Superiority Trial without modifications after an unblinded data review confirmed no safety concerns. This trial aims to evaluate the efficacy of Mino-Lok® in treating catheter-related infections. Approximately 144 subjects will be randomized to assess the treatment's effectiveness. The favorable DMC recommendation reflects the potential to achieve primary endpoints, reassuring stakeholders as Citius engages with the FDA for further guidance.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) announced the appointment of Dr. John Laffey to its ARDS Scientific Advisory Board, effective immediately. Dr. Laffey is recognized for his expertise in Acute Respiratory Distress Syndrome (ARDS) and gene-based therapies. His involvement aims to enhance Citius's innovative i-MSC program, which focuses on stem cell therapy for ARDS, particularly in relation to COVID-19. This addition complements a board of esteemed experts, indicating a strengthened leadership and potential for advanced clinical development in critical care products.
Citius Pharmaceuticals (CTXR) announced the next interim analysis of its Phase 3 trial for Mino-Lok®, an antibiotic solution for catheter-related bloodstream infections, is set for June 29, 2021. The independent Data Monitoring Committee (DMC) will review trial data for safety and efficacy. Over 80% of the expected 144 patients are enrolled in the study. Mino-Lok® aims to be the first FDA-approved treatment for salvaging central venous catheters, potentially reducing serious adverse events and healthcare costs.
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.
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