Why Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) Belongs on Your Watchlist: FDA Updates

Drop everything this moment and pull up: Citius Pharmaceuticals, Inc. (CTXR). Citius Pharmaceuticals, Inc. (CTXR) Is On Immediate Breakout Watch Thursday Afternoon April 18th Dear Reader,  Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) needs to be on your radar now! There’s only a few minutes left before the closing bell.  We may not see this company at these levels for much longer. Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) recently unveiled groundbreaking news: the FDA's acceptance of the Biologics License Application (BLA) resubmission for LYMPHIR™ (Denileukin Diftitox). This marks a pivotal moment in the company's journey toward addressing unmet medical needs, particularly in the treatment of adults with relapsed or refractory Cutaneous T-Cell Lymphoma (CTCL). Key Highlights: - FDA Approval Progress: The FDA has assigned a Prescription Drug User Fee Act (PDUFA) target action date of August 13, 2024, signifying a significant step forward in the regulatory process for LYMPHIR™. - Clinical Significance: LYMPHIR™ represents a novel IL-2R immunotherapy designed to address the critical unmet need for effective treatments in CTCL patients who have undergone at least one prior systemic therapy. - Optimistic Outlook: Leonard Mazur, Chairman and CEO of Citius Pharmaceuticals, expressed confidence in the company's response to the FDA's requirements, highlighting the completeness of their data package and emphasizing the potential benefit LYMPHIR™ may offer to patients with relapsed or refractory CTCL.  - Therapeutic Mechanism: LYMPHIR™ is a recombinant fusion protein targeting IL-2 receptors on the cell surface, effectively inhibiting protein synthesis within cells. With orphan drug designation and promising clinical data, LYMPHIR™ holds significant promise as a potential breakthrough therapy. - Disease Background: CTCL is a challenging form of cutaneous lymphoma characterized by cancerous T-cells in the skin, leading to skin lesions and a decrease in patients' quality of life. Despite current therapies, there remains a critical unmet need for curative treatments in advanced CTCL cases. Citius Pharmaceuticals' commitment to advancing LYMPHIR™ underscores its dedication to improving patient outcomes and addressing critical gaps in treatment options. As the company awaits the FDA's decision, the anticipation surrounding LYMPHIR™'s potential approval continues to grow, offering hope to CTCL patients and healthcare professionals alike. See today’s earlier notes on Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) below: Drop everything this moment and pull up: Citius Pharmaceuticals, Inc. (CTXR). Citius is a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, with a focus on oncology, anti-infectives in adjunct cancer care, unique prescription products, and stem cell therapies. Check out the company's website here. And right now, CTXR has 2 potential catalysts to soak in quickly: No. 1 CTXR Potential Catalyst - Could Multiple Triggered Technicals Signal Something Big On The Horizon? I'm telling you right now... Don't discount CTXR's bullish technical indicators. At lunchtime Thursday, CTXR was displaying several triggered technical indicators across the short, medium term, and long term. [Barchart]( was reporting these as triggered: Short Term Indicators - 20 - 50 Day MACD Oscillator - 20 - 100 Day MACD Oscillator - 20 - 200 Day MACD Oscillator Medium Term Indicators - 50 Day Moving Average - 50 - 100 Day MACD Oscillator - 50 - 150 Day MACD Oscillator - 50-200 Day MACD Oscillator Long Term Indicators - 100 Day Moving Average - 150 Day Moving Average - 200 Day Moving Average Watch these technicals closely this week. ----- No. 2 CTXR Potential Catalyst - Huge News From Last Week Could Be The Beginning Of Something Big... Citius Pharmaceuticals Announces Addition of City of Hope to UMN's Phase 1 Trial of LYMPHIR in Combination with CAR-T for the Treatment of B-Cell Lymphoma National Cancer Institute (NCI)-designated research and treatment center City of Hope, in Duarte, CA, to participate in the University of Minnesota (UMN) Masonic Cancer Center's ongoing Phase 1 trial to determine the maximum tolerated dose of LYMPHIR plus CAR-T therapy CRANFORD, N.J., April 11, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR),..., today announced that the University of Minnesota Masonic Cancer Center intends to expand their ongoing investigator-initiated Phase 1 trial of LYMPHIR™ (denileukin diftitox) in combination with FDA-approved CAR-T products for the treatment of B-cell lymphomas. The ongoing study, led by Dr. Veronika Bachanova at the University of Minnesota (UMN), will include an additional study site at City of Hope (COH), a world-renowned cancer treatment and research institution, with Dr. Matthew Mei as the principal site investigator at COH. City of Hope is one of only 53 National Cancer Institute (NCI)-designated comprehensive cancer centers in the U.S. "We are encouraged by the scientific community's interest in exploring the potential benefits of LYMPHIR beyond cutaneous T-cell lymphoma, for which a Biologics License Application is currently under review by the FDA. We are very excited to support UMN's expansion of its study to City of Hope as distinguished oncologists Dr. Bachanova and Dr. Mei conduct innovative research to evaluate LYMPHIR in combination with CAR-T treatment," stated Dr. Myron Czuczman, Chief Medical Officer of Citius. "This first-of-its-kind study will evaluate the potential value that transient depletion of T-regs within the tumor microenvironment by LYMPHIR has upon CAR-T-based anti-tumor activity," added Dr. Czuczman. [Read the full article here.]( ----- Drop everything and get CTXR on your radar now. If there are any updates, we'll get them out quickly. Sincerely, FierceAnalyst | Jaks Swift Editorial Writer (Always Remember The St-ock Prices Could Be Significantly Lower Now From The Dates I Provided.) FierceInvestor (FierceInvestor . com) is owned by SWN Media LLC, a limited liability company. Ownership of FI has now moved to a single individual. Disclosure: I am not a lic-ensed fina-ncial adviser. Make sure to always do your own research and due diligence on any day and swing profile I bring to your attention. Fierce full disclosure is to be read and fully understood before using Fierce's website, or joining Fierce's email or text list. 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We own zero shares of (CTXR). Pursuant to an agreement between StockNewsWire LLC and Venado Media LLC, StockWireNews has been hired for a period beginning on 4/2/20 and ending on 4/3/20 to publicly disseminate information about (CTXR) via Website, Email and SMS. We were paid twenty-five thousand five hundred USD via bank wire transfer. We own zero shares of (CTXR). Pursuant to an agreement between StockNewsWire LLC and Venado Media LLC, StockWireNews has been hired for a one day period on 4/28/20 to publicly disseminate information about (CTXR) via Website, Email and SMS. We were paid twenty-seven thousand five hundred USD via bank wire transfer. We own zero shares of (CTXR). Pursuant to an agreement between StockNewsWire LLC and Venado Media LLC, StockWireNews has been hired for a one day period on 5/13/20 to publicly disseminate information about (CTXR) via Website, Email and SMS. We were paid seven thousand five hundred USD via bank wire transfer. We own zero shares of (CTXR). Pursuant to an agreement between StockNewsWire LLC and Venado Media LLC, StockWireNews has been hired for a two day period beginning on 6/2/20 and ending on 6/3/20 to publicly disseminate information about (CTXR) via Website, Email and SMS. We were paid seventeen thousand five hundred USD via bank wire transfer. We own zero shares of (CTXR). Pursuant to an agreement between StockNewsWire LLC and Venado Media LLC, StockWireNews has been hired for a two day period beginning on 7/7/20 and ending on 7/8/20 to publicly disseminate information about (CTXR) via Website, Email and SMS. We were paid twenty-seven thousand five hundred USD via bank wire transfer. We own zero shares of (CTXR). Pursuant to an agreement between StockNewsWire LLC and Venado Media LLC, StockWireNews has been hired for a two day period beginning on 8/4/20 and ending on 8/5/20 to publicly disseminate information about (CTXR) via Website, Email and SMS. We were paid ten thousand USD via bank wire transfer. 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We have been paid ninety-five thousand USD via bank wire transfer. We own zero shares of (CTXR). Pursuant to an agreement between StockNewsWire LLC and Legends Media, LLC, StockWireNews has been hired for a period beginning on 7/8/21 and ending on 7/9/21 to publicly disseminate information about (CTXR) via Website, Email and SMS. We have been paid seventeen thousand five hundred USD via bank wire transfer. We own zero shares of (CTXR). Pursuant to an agreement between StockNewsWire LLC and Legends Media LLC, StockWireNews has been hired for a period beginning on 9/7/21 and ending on 9/8/21 to publicly disseminate information about (CTXR) via Website, Email and SMS. StockNewsWire LLC was paid sixty-seven thousand five hundred USD via bank wire transfer. We own zero shares of (CTXR). 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