🚨Trade Alert 🚨 CTXR

🚨Trade Alert 🚨 CTXR͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ ͏ ‌ CTXR is a $1 BIOTECH Company that Carries a $10 Price Target and Potential FDA APPROVAL this Year! Greetings All, Biotech is staged for a major comeback in 2023. [Merck CEO Robert Davis]( used the word "confident" more than 20 times in his presentation at the JPMorgan healthcare conference earlier this year, setting the tone for how the biotech industry feels in 2023.He even told JPMorgan analyst Chris Schott during his speech, "Hopefully you’re getting the sense that my confidence is quite high." With the Federal Reserve hopefully starting to slow down its rate increases, the biotech sector has a decent chance of staging a recovery.Biotech is one of the most thrilling arenas where a simple news announcement about a study or trial can send shares exploding. And then there’s the potential of a holy grail FDA announcement…. This is usually what keeps investors watching biotech companies like hawks.Finding remarkable companies in this space that are relatively anonymous compared to bigger players in the industry is what savvy investors hunt for. Finding them equipped with cash? Even better.That puts attention on to an emerging biotech player called Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) which impressively has [$36.9M in cash and cash equivalents]( as of December 31st, 2022. The company has a runway through February of 2024!CTXR is a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products. The bounce potential here is staggering and shares have already been catapulting higher since reaching a low in December.Since plunged to a 52-week low in December but CTXR has managed to climb back nearly 40% since then. There’s [a $10 price target]( on shares which indicates an upside potential of over 840%! Not that long ago CTXR CEO Leonard Mazur also assured that he was confident that 2023 will be a big year for the company and there could be FDA approval this year! “We are encouraged by the multiple value-driving catalysts anticipated in calendar 2023, including a potential drug approval and two trial completions, and look forward to extending our positive momentum in the months ahead," concluded Mazur. With a diversified pipeline, over 8% of shares held by insiders, over $36M of cash on hand, and products addressing some of the world's most addressable markets, Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) is a biotech company that may be trading at a supreme premium right now…. [( NASDAQ: CTXR Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is a late-stage biopharmaceutical company focused on the development and commercialization of first-in-class critical care products, with a pipeline of anti-infectives in oncology, adjunct cancer care, stem cell therapy and unique prescription products. The company's diversified pipeline of therapies targeting unmet medical needs includes three potential first-and-only prescription treatments in their indications, and a next-generation single-donor, allogeneic, clonal and scalable stem cell therapy program. Fiscal Q1 2023 Business Highlights and Subsequent Developments - I/ONTAK (E7777) biologics license application (BLA) under review by the U.S. Food and Drug Administration (FDA) with Prescription Drug User Fee Act (PDUFA) target decision date of July 28, 2023; - Mino-Lok® Phase 3 trial progressing with additional enrollment and events in the U.S. and India; - Phase 2b trial of Halo-Lido for the treatment of hemorrhoids on track with healthy momentum in patient recruitment; and, - On February 7, 2023, Dennis M. McGrath was elected to the Citius Board of Directors at the Annual Meeting of Stockholders, replacing Director Dr. William Kane. "As we entered 2023, Citius continued to build momentum across the pipeline. Our Mino-Lok Phase 3 trial is actively enrolling patients in the U.S. and India. We believe the recent uptick in recruitment at clinical sites will aid in completing the trial this year. Regarding our I/ONTAK (E7777) BLA, we anticipate the FDA's decision in late July. Accordingly, we remain focused on ensuring that our regulatory, commercial and manufacturing activities are positioned to support a successful launch, if approved. Moreover, our team has worked diligently to align resources to support the Phase 2b Halo-Lido trial as it nears completion," stated Leonard Mazur, Chairman and CEO of Citius. Unlocking Potential Faster by Pioneering a Novel Class of Tissue-Specific Therapeutics! CTXR has two late-stage product candidates, Mino-Lok®, an antibiotic lock solution for the treatment of patients with catheter-related bloodstream infections (CRBSIs), which is currently enrolling patients in a Phase 3 Pivotal superiority trial, and I/ONTAK (E7777), a novel IL-2R immunotherapy for an initial indication in cutaneous T-cell lymphoma (CTCL), which has completed subject treatment in its Pivotal Phase 3 trial. Mino-Lok® was granted Fast Track designation by the U.S. Food and Drug Administration (FDA). I/ONTAK has received orphan drug designation by the FDA for the treatment of CTCL and peripheral T-cell lymphoma (PTCL)! Mino-Lok Mino-Lok® is an antibiotic lock solution used to treat patients with catheter-related bloodstream infections (CRBSIs) and central line associated bloodstream infections (CLABSIs). CRBSIs/CLABSIs are life-threatening conditions, especially in cancer patients receiving therapy through central venous catheters (CVCs) and in hemodialysis patients where venous access presents a challenge. Mino-Lok® is intended to salvage the CVC, avoiding the need to remove and replace the infected catheter. Currently, there are few alternatives to removing and replacing a CVC once it becomes infected! Program Highlights ►Mino-Lok® is the first & only therapy under investigation to salvage infected CVCs► In a Phase 2b trial, Mino-Lok® demonstrated a 100% efficacy rate in salvaging colonized CVCs; Mino-Lok® had no significant adverse events compared to an 18% serious adverse event rate when infected CVCs were removed and replaced. [Learn more…]( A multicenter Phase 3 pivotal superiority trial is currently underway. more…]( was granted QIDP and Fast Track designation by the FDA and has patent protection through 2024 and formulation patent protection through 2036►Citius licensed the worldwide rights to Mino-Lok® from The University of Texas MD Anderson Cancer Center I/ONTAK (E7777) I/ONTAK (E7777), is a purified reformulation of denileukin diftitox (ONTAK®), a previously FDA-approved cancer immunotherapy for the treatment of persistent or recurrent cutaneous T-cell lymphoma (CTCL), a rare form of non-Hodgkin lymphoma. Considered to be incurable, CTCL is a general term for T-cell lymphoma that involve the skin, but may also involve the blood, lymph nodes, and internal organs. E7777 received regulatory approval in Japan for the treatment of CTCL and PTCL in 2021. Citius’s exclusive license include rights to develop and commercialize I/ONTAK (E7777) in all markets except for Japan and certain parts of Asia. Program Highlights ► Phase 3 Pivotal trial completed December 2021; top line results are consistent with the prior formulation► Biologics license application (BLA) submission expected to be filed in the second half of 2022 for an initial indication in CTCL► Considered a new biologic by the FDA, I/ONTAK would potentially be eligible for 12 years of exclusivity, if approved Halo-Lido Halo-Lido (CITI-002) is a proprietary topical formulation of halobetasol and lidocaine that is intended to provide anti-inflammatory and anesthetic relief to individuals suffering from hemorrhoids. In the United States, hemorrhoids affect nearly 5% of the population, with approximately 10 million patients annually reporting symptoms. Program Highlights ► There are no FDA-approved prescription products on the market for hemorrhoids► Citius’ halobetasol and lidocaine formulation could become the first FDA-approved prescription product to treat hemorrhoids in the United States► According to IMS, over 25 million units of topical combination prescription products for hemorrhoids are sold in the US Through its subsidiary, NoveCite, Inc., CTXR is also developing a novel proprietary mesenchymal stem cell treatment derived from induced pluripotent stem cells (iPSCs) for acute respiratory conditions, with a near-term focus on acute respiratory distress syndrome (ARDS). Fiscal Full Year 2022 Business Highlights and Subsequent Developments - Completed Pivotal Phase 3 trial of I/ONTAK (E7777) and submitted biologics license application (BLA) to the U.S. Food and Drug Administration (FDA); - FDA confirmed Prescription Drug User Fee Act (PDUFA) target action date of July 28, 2023; - Advanced Mino-Lok® Phase 3 trial and it is now significantly closer to completion - Initiated Phase 2b trial of Halo-Lido for the treatment of hemorrhoids in April 2022; patient enrollment ongoing with data readout expected 2H 2023; - Initiated clinical collaboration with the University of Pittsburgh to evaluate regulatory T-cell (T-reg) depletion with I/ONTAK (E7777) in combination with pembrolizumab in recurrent or metastatic solid cancer tumors in a Phase 1 investigator-initiated trial, with first patient enrolled in November 2022; and, - Approved for $3.6 million in non-dilutive capital through the New Jersey Economic Development Program to support ongoing research and development efforts. In summary…. Some scientists believe that we’re in the "golden age" of biotechnology. Scientific advances are creating new ways, previously only imaginable, to treat and prevent diseases. This is what makes the biotech arena so thrilling. What could be better than a biotech company with exciting products that could save lives? As biotech stages its big comeback this year, CTXR at around $1 could be one of the biggest comeback stories as well! Innovation is one of the biggest things going for the biotech sector. With expectations that the arena will rebound and inflect higher gaining ground, CTXR has several developments that could put it on the Street's radar this year including FDA approval!! BULLISH ratings, a hefty $10 Price Target, and a CEO confident about an FDA approval are also very good reasons to have the stock high on your radar! With a pipeline that makes the company well situated among existing targeted therapies and TWO candidates that could be the FIRST and ONLY FDA-approved products and therapies in their markets, CTXR could be positioned for BIG MOVES in 2023! Start your research right away! Copyright 2022 © SCDalerts.com is owned and operated by the owner of SCD Media LLC. Disclaimer and Privacy For more Information please contact info@smallcapsdaily.com This website provides information about the stock market and other investments. This website does not provide investment advice and should not be used as a replacement for investment advice from a qualified professional. This website is for informational purposes only. The Author of this website is not a registered investment advisor and does not offer investment advice. You, the reader, bear responsibility for your own investment decisions and should seek the advice of a qualified securities professional before making any investment. 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