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 reports developments across its critical care and targeted oncology business, including activity at majority-owned subsidiary Citius Oncology. The company’s recurring updates center on LYMPHIR (denileukin diftitox-cxdl), an engineered IL-2 diphtheria toxin fusion protein approved for adults with relapsed or refractory Stage I–III cutaneous T-cell lymphoma after at least one prior systemic therapy.
Company news also covers LYMPHIR commercialization, U.S. launch progress, international access through Named Patient Programs, and investigator-initiated oncology studies involving gynecologic cancers and diffuse large B-cell lymphoma. Capital updates include registered direct offerings, warrant issuances, non-dilutive funding and other financing actions that support product commercialization and development programs.
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.
Citius Pharmaceuticals (CTXR), a late-stage biopharmaceutical company, announced its presentation at the H.C. Wainwright Global Investment Conference scheduled for May 24, 2022. CEO Leonard Mazur will discuss recent business developments and milestones. The event will take place virtually and at the Fontainebleau Miami Beach Hotel. Registrants can access a live webcast and schedule 1-on-1 meetings with management. Citius is focused on innovative critical care products, including Mino-Lok® and I/ONTAK, addressing serious medical conditions.
Citius Pharmaceuticals (CTXR) reported a net loss of $7.6 million for Q2 2022, up from $4.1 million in Q2 2021. Cash reserves stand at $55.8 million with no debt, ensuring operational sustainability through March 2023. Significant developments include the expansion of the Mino-Lok® Phase 3 trial to international sites, with completion expected by late 2022. Topline results for I/ONTAK (E7777) indicate consistency with prior formulations, and a biologics license application is anticipated in 2H 2022. R&D and G&A expenses increased due to new trials and operational scaling.