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. (CTXR) has announced that abstracts for I/ONTAK (E7777) will be presented at the 64th ASH Annual Meeting on December 11, 2022. The presentations will include an oral review of the efficacy and safety data from the completed Phase 3 study by Dr. Francine Foss, alongside a poster presentation of safety data by Dr. Christiane Querfeld. The company has submitted a Biologics License Application to the FDA, highlighting the potential of I/ONTAK as a treatment for relapsed or refractory cutaneous T-cell lymphoma.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) announced that Chairman and CEO Leonard Mazur will present at the ThinkEquity Conference on October 26, 2022, at 1:00 PM ET, in New York City. The conference will focus on the company's late-stage biopharmaceutical developments, including Mino-Lok® and I/ONTAK, aimed at treating critical health conditions. Investors can register to view the live presentation and are encouraged to request one-on-one meetings through the conference platform.
Citius Pharmaceuticals, a late-stage biopharmaceutical company focused on critical care products, will be represented by Chairman and CEO Leonard Mazur at the Dawson James Securities Small Cap Growth Conference on October 12, 2022, at 3:30 PM ET in Jupiter, Florida. The live presentation will be available via webcast, and a replay will be accessible for 90 days on the Company’s Investors website.
Citius Pharmaceuticals has submitted a Biologics License Application (BLA) to the FDA for denileukin diftitox (I/ONTAK), targeting cutaneous T-cell lymphoma (CTCL). This engineered IL-2-diphtheria toxin fusion protein offers a more purified formulation of the previously approved ONTAK. The BLA filing is underpinned by a pivotal Phase 3 study whose results align with past data. Citius aims to address the unmet needs in advanced CTCL treatment, highlighting the pressing demand for effective therapies.
Citius Pharmaceuticals, Inc. (CTXR) announced a collaboration with the University of Pittsburgh for a Phase 1 clinical trial evaluating I/ONTAK in combination with pembrolizumab for treating recurrent or metastatic solid tumors. This trial aims to enhance T-cell responses, potentially improving patient outcomes. The study, set to begin in Q4 2022, aims to enroll 18-30 patients in a dose escalation followed by approximately 40 patients for dose expansion. The trial seeks to assess safety, tolerability, and immune response alterations, advancing innovative cancer treatments.
Citius Pharmaceuticals, Inc. (CTXR) has been honored by the Somerset Hills Learning Institute, with its CFO Jaime Bartushak receiving recognition for their contributions. The Institute focuses on autism education and has saved New Jersey taxpayers over $60 million by returning children to neighborhood schools. The 23rd Annual Halloween Ball, the Institute's largest fundraising event, is scheduled for October 28, 2022. Citius is engaged in developing critical care products, including Mino-Lok® and I/ONTAK, with ongoing clinical trials expected to influence its market position.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) will present at the H.C. Wainwright 24th Annual Global Investment Conference on September 14, 2022, at 11:00 am EDT. Chairman and CEO Leonard Mazur will conduct an in-person presentation at the Lotte New York Palace Hotel, with registered participants able to access the live webcast. Citius focuses on developing critical care biopharmaceuticals, including late-stage candidates Mino-Lok® and I/ONTAK (E7777). The conference runs from September 12-14, 2022, in New York City.
Citius Pharmaceuticals (CTXR) reported third-quarter results for 2022, highlighting $48 million in cash and no debt. The Mino-Lok® Phase 3 trial is seeing increased recruitment, with international sites now engaged. The company remains on track for a Biologics License Application (BLA) submission for I/ONTAK in the second half of 2022. Research and Development (R&D) expenses rose to $4.9 million for the quarter. The net loss for Q3 was $8.9 million, up from $5.8 million a year prior, due to heightened R&D and administrative costs.
Citius Pharmaceuticals (CTXR) announced a Type B pre-BLA meeting with the FDA on July 12, 2022, for I/ONTAK, a treatment for cutaneous T-cell lymphoma (CTCL). The Company plans to submit a Biologics License Application (BLA) in the second half of 2022, following FDA guidance. I/ONTAK is a purified formulation of the previously approved ONTAK, designed to target IL-2 receptors. Approximately 3,000 new CTCL cases are reported annually in the U.S., highlighting the potential market for this treatment.
Citius Pharmaceuticals announced plans for a spinoff of its oncology asset I/ONTAK into a new publicly-traded company (NewCo) while retaining Mino-Lok and other pipeline assets. Citius will continue trading on Nasdaq under the ticker CTXR. The spinoff aims to optimize resources and attract investors by creating two focused companies. The IPO and stock distribution to shareholders are expected in the second half of 2022 and are structured to qualify as a tax-free transaction. Completion is subject to board and regulatory approvals.
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