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 its participation in two investor conferences in October 2021. The first event is the Benzinga Rising Stars Conference on October 7, 2021, where Executive Chairman Leonard Mazur will present at 9:05 a.m. ET. The second is the Dawson James Securities 6th Annual Small Cap Growth Conference on October 21, 2021, with Mazur presenting at 8:55 a.m. ET. Citius is focused on critical care products in oncology, including late-stage assets like Mino-Lok® and I/ONTAK (E7777).
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) announced that Leonard Mazur, Executive Chairman, and his wife, Helena, were honored by Temple University, which renamed its main building for the College of Liberal Arts to Leonard and Helena Mazur Hall. This honor recognizes their significant contributions to the university and commitment to enhancing student opportunities. The event occurred on September 30, 2021, and underscores the Mazurs' role in supporting higher education and career development for students. Citius continues to focus on critical care products, including two late-stage therapies.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) will join Benzinga's All Access Show for a 20-minute interview on September 17, 2021, at 10:10 am ET. Chairman Leonard Mazur will discuss advancements in the company's late-stage clinical pipeline, focusing on I/ONTAK (E7777), a novel oncology asset with potential for near-term revenue and a robust path toward commercial success. Citius is noted for its late-stage candidates, including Mino-Lok®, which is in a Phase 3 trial, and I/ONTAK, having completed enrollment in its pivotal Phase 3 trial.
Citius Pharmaceuticals (Nasdaq: CTXR) announced its participation at the H.C. Wainwright 23rd Annual Global Investment Conference, scheduled for September 13-15, 2021. The company will provide a presentation video available on demand starting at 7:00 am ET on September 13th. Key discussions will include the company's expanded pipeline and upcoming catalysts, featuring insights from CEO Myron Holubiak and CMO Myron Czuczman. The archived webcast will be up for 90 days post-event. Citius focuses on critical care products in oncology, anti-infectives, and stem cell therapies.
Citius Pharmaceuticals, Inc. (CTXR) announced a definitive agreement to acquire Dr. Reddy's Laboratories' exclusive license for E7777, an advanced oncology immunotherapy for treating Cutaneous T-cell Lymphoma (CTCL). The acquisition involves a $40 million upfront payment, additional milestones totaling up to $110 million, and royalty payments on net sales. E7777, a reformulated version of ONTAK, is nearing FDA approval with a Biologics License Application expected by late 2022. Citius aims to enhance its pipeline and target approximately 30% of the CTCL patient population, estimated at 30,000 to 40,000 in the U.S.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) reported its financial results for Q3 2021, showing a net loss of $5.8 million and cash equivalents of $115.7 million. Key highlights include a positive recommendation from the Data Monitoring Committee for the Mino-Lok® trial and advances in stem cell therapy development. The company also raised $127.6 million in financing during H1 2021, with an increase in authorized shares to support growth. However, recruiting for the Mino-Lok® trial may slow due to COVID-19 disruptions.
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.
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