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. (Nasdaq: CTXR) is a biopharmaceutical company focused on first-in-class critical care products and holds a majority interest in Citius Oncology, Inc. News about CTXR often centers on regulatory milestones, clinical progress, and financing activities that support the development and commercialization of its therapies.
Recent company communications emphasize the FDA approval of LYMPHIR (denileukin diftitox-cxdl) for adult patients with relapsed or refractory Stage I–III cutaneous T-cell lymphoma after at least one prior systemic therapy, and the subsequent U.S. commercial launch executed by Citius Oncology. CTXR news also highlights the late-stage status of Mino-Lok, a catheter lock solution for catheter-related bloodstream infections, and CITI-002 (Halo-Lido), a topical formulation for hemorrhoid relief, along with completed pivotal and Phase 2b trials.
Investors following CTXR can expect updates on capital raises such as registered direct offerings and warrant issuances, which the company states are intended to fund the commercial launch of LYMPHIR, regulatory and milestone payments, and broader development initiatives. Filings and press releases also describe ongoing engagement with the FDA regarding next steps for Mino-Lok and Halo-Lido.
This news feed aggregates press releases, regulatory disclosures, and other public announcements related to Citius Pharmaceuticals and its majority-owned oncology subsidiary. For those tracking CTXR, it provides a centralized view of developments across oncology, critical care, clinical trials, and corporate finance. Regular review of this page can help readers monitor how Citius Pharmaceuticals advances its portfolio and supports the commercialization of LYMPHIR through Citius Oncology.
Citius Pharmaceuticals (Nasdaq: CTXR) announced positive topline results from its Phase 3 trial of I/ONTAK (E7777) for the treatment of persistent or recurrent cutaneous T-cell lymphoma (CTCL). The trial demonstrated an Objective Response Rate (ORR) of 36.2% based on independent review and 42.3% based on investigator assessments. No new safety concerns were identified, and the company plans to file a biologics license application (BLA) with the FDA in H2 2022. This marks a significant step towards potentially launching its first commercial product.
Citius Pharmaceuticals (Nasdaq: CTXR) will present at two investor conferences in March 2022. Leonard Mazur, Executive Chairman, will discuss recent developments and future milestones. The conferences include the 34th Annual ROTH Conference (March 13-15 at Ritz-Carlton, Laguna Niguel, California) and Maxim's 2022 Virtual Growth Conference (March 28-30, virtual). Participants can view on-demand presentations and schedule 1-on-1 meetings.
Citius focuses on oncology, anti-infectives, and stem cell therapies, with products like Mino-Lok® and I/ONTAK in late-stage trials.
Citius Pharmaceuticals (CTXR) announced the FDA's acceptance of its Investigational New Drug (IND) application for Halo-Lido, a treatment for hemorrhoids. This proprietary formulation combines halobetasol and lidocaine, aiming to alleviate painful symptoms associated with hemorrhoids, which affect over 10 million individuals annually in the U.S. The company plans to initiate a Phase 2b clinical trial in 2022, involving 300 participants to assess the efficacy of Halo-Lido. This development marks a significant step toward providing relief for patients suffering from hemorrhoidal disease.
Citius Pharmaceuticals (CTXR) reported its fiscal Q1 2022 results on February 10, 2022. The company had cash and equivalents of $65.4 million and a net loss of $9.2 million (or ($0.06) per share). R&D expenses decreased to $5.5 million, while G&A expenses rose to $2.9 million. Key developments include the completion of the Phase 3 trial for I/ONTAK, with topline results expected in H1 2022. New executives have been added to strengthen regulatory and clinical capabilities, supporting the late-stage pipeline.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) announced its participation in two virtual conferences in January 2022. Presentations will be accessible on-demand beginning January 10, 2022. The events include the H.C. Wainwright BioConnect Conference from January 10-13 and Biotech Showcase™ 2022 on January 10-12 and 17-19. Archived webcasts will be available for 90 days on the Citius website. The company focuses on critical care products, including Mino-Lok® and I/ONTAK, both in late-stage development. For more details, visit www.citiuspharma.com.
Citius Pharmaceuticals (Nasdaq: CTXR) reported its fiscal year 2021 results, highlighting significant advancements and financial activities. The company completed the subject treatment in the pivotal Phase 3 trial of I/ONTAK and expects topline results in the first half of 2022, with a BLA submission set for the second half. They raised $120.6 million in financing, boosting cash reserves to $70.1 million. However, the net loss increased to $23.1 million, primarily due to rising R&D and G&A expenses. Citius is positioned for growth with a robust pipeline and anticipates multiple milestones in 2022.
Citius Pharmaceuticals, Inc. (CTXR) has completed patient enrollment in its pivotal Phase 3 trial for I/ONTAK, a treatment for recurrent cutaneous T-cell lymphoma (CTCL). With 70 patients enrolled, the study aims to evaluate the drug's efficacy and safety, with topline results expected in H1 2022. The biologics license application (BLA) is anticipated in H2 2022. I/ONTAK, a reformulation of the previously approved ONTAK, targets IL-2 receptors and has received orphan drug designation from the FDA. This marks a significant step in expanding treatment options for advanced CTCL patients.
Citius Pharmaceuticals, Inc. (CTXR) announced the appointment of Kelly Creighton, PhD, as Executive Vice President of Chemistry, Manufacturing and Controls. Dr. Creighton brings nearly two decades of pharmaceutical industry expertise, with over 50 investigational new drug submissions and 20 approved applications. He will oversee global regulatory and manufacturing strategies for Citius's five pipeline programs, as the company prepares for commercial success with two late Phase 3 trials nearing completion. Management expresses confidence in his ability to drive the company’s clinical development and regulatory pathways forward.
Citius Pharmaceuticals (Nasdaq: CTXR) announced a KOL webinar on November 11, 2021, at 11:30 AM ET addressing the salvage of central venous catheters in patients with CLABSI. Leading experts Issam Raad from MD Anderson and Mark Rupp from the University of Nebraska will discuss the unmet medical needs and the impact of COVID-19 on infection rates. Citius's Chief Medical Officer, Myron Czuczman, will provide updates on Mino-Lok®, their antibiotic treatment for catheter-related infections, currently in a Phase 3 clinical trial. Pre-registration is required for participation.
Citius Pharmaceuticals (Nasdaq: CTXR) will host a webcast on October 20, 2021, at 8:30 a.m. ET, to discuss its acquisition of I/ONTAK (E7777), an enhanced formulation of the immunotoxin ONTAK, previously FDA-approved for cutaneous T-cell lymphoma (CTCL). CEO Myron Holubiak and other executives will outline the company's strategy and the potential of I/ONTAK, which has received regulatory approval in Japan and orphan drug designation from the FDA. A pivotal study on I/ONTAK is underway, with results expected in mid-2022.