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, Inc. (Nasdaq: CTXR) announced participation in the Virtual Fall Investor Summit from November 16-18, 2020. Chairman Leonard Mazur will present a corporate overview on November 16 at 1:00 p.m. ET and engage in one-on-one investor meetings. Updates on Mino-Wrap, focused on reducing surgical infection risks, and Mino-Lok®, aimed at treating catheter-related infections, will be discussed. The company recently licensed induced mesenchymal stem cells for potential COVID-19 treatment, indicating an expansion of its critical care drug portfolio.
Citius Pharmaceuticals, a late-stage specialty pharmaceutical company, announced its participation in the H.C. Wainwright 6th Annual Israel Conference on November 12, 2020. CEO Myron Holubiak will present an update on the company’s product pipeline at 2:30 p.m. ET and conduct one-on-one investor meetings. This follows the release of their October 2020 Letter to Shareholders, detailing recent business and clinical developments. For more information, visit the corporate update.
Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) announced recent updates in its October 2020 Letter to Shareholders, highlighting significant developments in its drug pipeline. The company secured an exclusive license with Novellus Therapeutics for a therapy targeting acute respiratory distress syndrome (ARDS), a COVID-19 complication. It also received a positive report from the Drug Monitoring Committee for its Mino-Lok Phase 3 trial and submitted a pre-investigational new drug request for Mino-Wrap, with FDA guidance expected in November 2020. A Phase 2b trial for Halo-Lido is slated to start in Q1 2021.
Novellus Therapeutics has licensed its induced mesenchymal stem cells (iMSCs) to NoveCite, a new subsidiary of Citius Pharmaceuticals (Nasdaq: CTXR). The agreement includes a $5 million upfront payment and potential milestone payments totaling up to $51 million, alongside low double-digit royalties. NoveCite aims to utilize these iMSCs to address acute respiratory conditions, particularly Acute Respiratory Distress Syndrome (ARDS) associated with COVID-19. Novellus holds a 25% equity stake in NoveCite, indicating a significant collaborative effort to innovate treatment options in critical care.
Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) announced on October 7, 2020, an exclusive licensing agreement with Novellus Therapeutics for iPSC-derived mesenchymal stem cells (NC-iMSCs), targeting acute respiratory conditions like Acute Respiratory Distress Syndrome (ARDS) related to COVID-19. This collaboration forms a new subsidiary, NoveCite, which aims to develop NC-iMSCs, believed to have superior potency and unlimited supply compared to traditional donor-derived stem cells. With over 3 million ARDS cases annually, this therapy holds potential for significant impact in critical care.
Citius Pharmaceuticals (CTXR) announced on September 30, 2020, that the Mino-Lok Clinical Trial Material at clinical sites has been replaced with registration batch product. This transition allows trial participants to receive Mino-Lok manufactured with the same process intended for commercial use post-FDA approval. CEO Myron Holubiak expressed satisfaction in providing common packaging for Mino-Lok components and indicated readiness for commercial manufacturing following successful Phase 3 trials and FDA clearance.
Citius Pharmaceuticals (Nasdaq: CTXR) announced positive outcomes from a Data Monitoring Committee (DMC) meeting regarding its Mino-Lok phase 3 trial. The DMC found no safety signals and recommended continuing the trial without modifications. Despite challenges in patient recruitment during the COVID-19 pandemic, the company is nearing the late stage of the pivotal study. CEO Myron Holubiak expressed confidence in Mino-Lok's safety and efficacy, highlighting the dedication of study investigators amidst challenges.
Citius Pharmaceuticals, Inc. (CTXR) has announced significant milestones for its antibiotic lock solution, Mino-Lok, designed for treating central line-associated bloodstream infections. The company has manufactured three registration lots for the New Drug Application (NDA) and placed them on stability at ICH conditions. Additionally, an exclusive synthesis process for EDTA has been developed. CEO Myron Holubiak emphasized the uniqueness of Mino-Lok, which includes three active drug substances. Citius aims to commence commercial manufacturing following the completion of a Phase 3 clinical trial and FDA approval.
Citius Pharmaceuticals (Nasdaq: CTXR) has filed an amendment to the Mino-Lok phase 3 protocol to improve clinical trial record-keeping amid COVID-19. This adjustment aims to address challenges faced in the ICU due to restricted personal visits. The company remains committed to collaborating with Principle Investigators for effective trial management. CEO Myron Holubiak expressed optimism about ongoing trials despite significant hurdles and anticipates a Drug Monitoring Committee meeting at the end of the month.
Citius Pharmaceuticals (Nasdaq: CTXR) announced its presentation at the H.C. Wainwright 22nd Annual Global Investment Conference, scheduled for September 14-16, 2020. Chairman Leonard Mazur will present on September 15 at 11:00 a.m. ET, discussing the company’s recent expansion in intellectual property related to Mino-Wrap and plans to address acute respiratory distress syndrome (ARDS) related to COVID-19. Additionally, updates on Mino-Lok® will be provided, focusing on catheter-related bloodstream infections. Virtual one-on-one investor meetings will also be conducted.