Nasdaq Biotech Profile (CTXR) Friday Update

Nasdaq Biotech Profile (CTXR) Friday Update [Find CTXR's 2 Major Analyst Targets Here - $5.50 Weighted Average]( September 18th, 2020 FierceAnalyst Member, CTXR remained steady yesterday while ending the session in the green up from Wednesday's close. In part it could be due to this week's major news release: [Citius Files Addendum to Mino-Lok Phase 3 Trial Record Keeping Protocol to Advance Trials with CV-19 Compliance]( Additionally, CTXR continues to display several bullish technical indicators in the short, medium, and long-terms according to Barchart. Remember, I brought this profile to you at the beginning of June and we watched as it marched over approximately 100% in the matter of weeks. Plus, we've recently seen CTXR hop on the vertical growth train over the past couple weeks. With CTXR holding $1.00 support now in back-to-back days, could this be a sign of further growth to come? Take a moment right now before the market opens and read my initial CTXR report below and get it pulled up quickly. ----- Citius Pharamceuticals, Inc. (CTXR) requires your immediate attention this morning. Previously, I brought this profile to your attention on June 3rd at approximately 9:30AM EST when it opened at $.97. Within a few weeks, CTXR rocketed all the way to a high of $1.97 for an overall surge of approximately 103%. Now, it could be on the verge of a new major breakout as a key line of resistance could break down shortly and provide a significant squeeze. As of this morning, CTXR is currently trading above its 200-Day Simple Moving Average and its 13-Day Exponential Average. Here's where things get interesting... Above is CTXR's 6-month chart and I've highlighted the key line to watch for a potential breakout. If CTXR is able to cross over its 50-Day Simple Moving Average, it could draw some serious buzz. When a profile is trading above all 3 of these lines (50-Day SMA, 200-Day SMA, and 13-Day EMA), it can witness a ton of momentum as those lines can be seen as strong support towards a vertical surge. Just take a look at the chart above. Can you see the recent green trend that has seen CTXR climb from a low of $.78 on September 4th to a high of $1.13 yesterday? But, What Else Could Be Signalling A Potential Breakout? According to [Barchart.com]( CTXR is displaying several bullish technical indicators that could be signalling a potential breakout in the near future. As of close on 9/16/20, Barchart was reporting these triggered "BUY" technicals: - 20 Day Moving Average - 20 - 200 Day MACD Oscillator - 50 - 100 Day MACD Oscillator - 50 - 150 Day MACD Oscillator - 50 - 200 Day MACD Oscillator - 100 Day Moving Average - 150 Day Moving Average - 200 Day Moving Average - 100 - 200 Day MACD Oscillator Additionally, the website is reporting CTXR to be an "40% BUY" based on overall technical indicators. Maybe you might not think that's great, but you need to recognize that 40% is up from last week's "24% SELL" recommendation. Once again, another sign CTXR is trending in the right direction. Here's What You Need To Know About The Bigger Picture The World House has called on U.S. health regulators to expedite potential therapies aimed at treating CV-19 amid the fast-spreading CV outbreak, saying it could lead to a breakthrough while a vaccine is still under development. Trials on potential CV therapies are already in the works, and FDA Commissioner Stephen Hahn said his agency was working quickly to examine all possibilities. "In the short term, we're looking at drugs that are already approved for other indications," Hahn said. "Since this outbreak first emerged, we've been working closely with our partners across the U.S government and around the globe to expedite the development and availability of critical medical products to help end this outbreak as quickly as possible." That's what makes Nasdaq profile, Citius Pharmaceuticals, Inc. (CTXR), such an exciting idea in the short-term. Citius Pharmaceuticals, Inc., a specialty pharmaceutical company, develops and commercializes critical care products. It primarily focuses on developing anti-infective, cancer care, and prescription products. The company's Mino-Lok product is an antibiotic lock solution used to treat patients with catheter-related bloodstream infections (CRBSIs). CRBSIs are very serious, especially in cancer patients receiving therapy through central venous catheters (CVCs) and in hemodialysis patients where venous access presents a challenge. The market potential for an effective antibiotic lock therapy is estimated at $750Mn per year in the U.S. and approximately $1.5Bn per year worldwide. According to DelveInsight, the market size of CRBSIs in the global market is expected to reach $1.84Bn in 2028, up from $1.24Bn in 2017. Total Incidence of Catheter Related Bloodstream Infection (CRBSI) in the Global Market is estimated to be 4 million patients. In the Asia Pacific region there were greater than 3 million CRBSIs. U.S. incidence is over 325,000. Assuming continued clinical success in Phase 3 trial and regulatory approval is achieved, Mino-Lok solution would address a major need in treating CRBSI patients. Potential CTXR Catalyst - Recent IP Announcement Citius Pharmaceuticals Announces Improved Design and Expansion of Intellectual Property for Mino-Wrap Expansion of patents granted to The University of Texas System on behalf of M. D. Anderson Cancer Center CRANFORD, N.J., Aug. 26, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced that it has expanded the intellectual property associated with its global license agreement with the MD Anderson Cancer Center ("MDACC"). Through this license agreement, Citius is developing Mino-Wrap, which is a novel approach to reducing post-mastectomy infections associated with the use of a tissue expander ("TE"). The United States Patent and Trademark Office (USPTO) has issued patent 10,434,221 B2 and patent application publication US 2019/0388591 A1, both continuations of the initial patent for "Antimicrobial Wraps for Medical Implants." The intellectual property expansion was granted to The Board of Regents of The University of Texas System on behalf of The University of Texas M. D. Anderson Cancer Center and enhances the design and use of Mino-Wrap. "The frequency of post-mastectomy breast reconstruction, following breast cancer treatment, has been increasing on an annual basis. There are over 100,000 patients in the U.S. undergoing breast reconstruction procedures following mastectomies and approximately 80% of the time, a TE is used to prepare the surgical site for breast implants either immediately after mastectomy or in a separate procedure afterwards. The published rate of infection for TEs used in breast reconstructive surgery is between 2.5 % and 24%, with an estimated mean at around 12% to 14%. These data points are concerning and not well understood. Through our agreement with MDACC, we believe Mino-Wrap has the potential to provide a significant reduction in the incidence of infection, sparing the patient the pain and discomfort of extended hospitalization and further aggressive and lengthy courses of antibiotics in an attempt to salvage the TEs. In many cases the TE is removed leading to a delay in lifesaving chemo-radiation therapy, which can be a devastating consequence for the patient," said Myron Holubiak, President and CEO of Citius Pharmaceuticals. "We are especially pleased that the claims for Mino-Wrap intellectual property are being expanded and broadened as we develop the optimal design and application." The Company is also currently developing Mino-Lok®, an antibiotic lock treatment for catheter-related bloodstream infections (CRBSIs), in collaboration with MDACC. Mino-Lok is in phase 3 development. Potential CTXR Catalyst - Briefing Package To FDA Citius Submits Mino-Wrap Briefing Package to FDA for Pre-IND Consult - Mino-Wrap being developed for the reduction of post-operative infections associated with breast reconstruction surgery - Mino-Wrap is the second major drug development collaboration with MD Anderson Cancer Center CRANFORD, N.J., Aug. 4, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius") ("Company") (NASDAQ: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products announced progress in the development of Mino-Wrap, a novel approach to reducing post-operative infections associated with surgical implants. Mino-Wrap is a gel-containing minocycline and rifampin film that is used to wrap the tissue expander ("TE") used in breast reconstructive surgeries. In order to stimulate early consultation and potentially speed the development of Mino-Wrap, the company has submitted a briefing package to the FDA Division of Anti-Infective Products. The briefing package contains information regarding pre-clinical data and a clinical development plan, along with questions for the FDA regarding safety and efficacy data that would be required to advance Mino-Wrap into clinical trials. The company will consider the feedback provided by the FDA in the development of the Pre-IND. There is no set timeline for FDA to respond to a consultation package; however, based on pre-CV-19 experience, we expect a response from FDA within 60 days. Mino-Wrap also marks the second collaboration with MD Anderson Cancer Center ("MDACC") who are the inventors of this novel approach to preventing post-mastectomy infections when tissue expanders are used. The Company is currently developing Mino-Lok®, an antibiotic lock treatment for catheter-related bloodstream infections (CRBSIs), in collaboration with MDACC. Mino-Lok is in phase 3 development. "The published rate of infection for tissue expanders used in breast reconstructive surgery is between 2.5 % and 24%, with an estimated mean at around 12% to 14%. We believe Mino-Wrap has the potential to provide a significant reduction in the incidence of infection, sparing the patient the pain and discomfort of extended hospitalization and further aggressive and lengthy courses of antibiotics in an attempt to salvage the TEs. In many cases the TE is removed leading to a delay in lifesaving chemo-radiation therapy, which can be a devastating consequence for the patient," said Myron Holubiak, President and CEO of Citius Pharmaceuticals. "We also are extremely honored to be working with the doctors and scientists at MD Anderson Cancer Center to develop another much-needed improvement in adjunctive cancer care. The early consultation with FDA allows for the identification of optimal strategies for our preclinical and clinical development programs. We are pleased to be taking advantage of this collaborative approach with the agency." Potential CTXR Catalyst - New Scientific Advisory Board Citius Pharmaceuticals Forms Scientific Advisory Board for the Planned Development of its Proprietary Treatment for Acute Respiratory Disease Associated with CV-19 CRANFORD, N.J., July 22, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("CITIUS") ("Company") (NASDAQ: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced today the formation of the Citius ARDS (Acute Respiratory Distress Syndrome) Scientific Advisory Board to provide the company expert guidance on its planned development of induced mesenchymal stem cells (iMSCs) under option from Novellus, Inc. to treat and reduce the severity of acute respiratory distress syndrome (ARDS) associated with CV-19. The ARDS Advisory Board consultants are: Michael A. Matthay, MD, Professor of Medicine and Anesthesia at the University of California at San Francisco (UCSF), a Senior Associate at the Cardiovascular Research Institute, and Associate Director of the Critical Care Medicine at UCSF. Dr. Matthay's basic research has focused on the pathogenesis and resolution of the acute respiratory distress syndrome (ARDS), with an emphasis on translational work and patient-based research, including clinical trials. Dr. Matthay's recent research has focused on the biology and potential clinical use of allogeneic bone marrow derived mesenchymal stromal cells (MSCs) for ARDS. He is currently leading the "Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome (STAT)," a United States Department of Defense supported study of MSCs for ARDS. Mitchell M. Levy, MD, Chief, Division of Pulmonary, Critical Care, and Sleep Medicine, Department of Medicine, The Warren Alpert Medical School of Brown University, where he is Professor of Medicine. Dr. Levy also serves as Medical Director of the Medical ICU at Rhode Island Hospital. He has been an investigator on numerous pharmacologic and biologic trials intended to treat sepsis, cardiovascular and pulmonary pathology. He has expertise in trial design, clinical trial execution and trial management and is one of the three founding members of the Surviving Sepsis Campaign (SSC). Dr. Levy is Past-President of the Society of Critical Care Medicine (2009). Lorraine B. Ware, MD, Professor of Medicine and Ralph and Lulu Owen Endowed Chair, Professor of Pathology, Microbiology and Immunology, Vanderbilt University; Director, Vanderbilt Medical Scholars Program. Dr. Lorraine Ware's comprehensive bench-to-bedside research program centers on the pathogenesis and treatment of sepsis and acute lung injury with a current focus on mechanisms of lung epithelial and endothelial oxidative injury by cell-free hemoglobin. Dr. Ware is also a lead investigator for the "Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome (STAT)" study. "We are extremely pleased to have been able to attract such a prestigious group of experts to advise and guide us in the Company's planned development of iMSC's for the treatment of ARDS" said Mr. Myron Holubiak, CEO of Citius. "These individuals are recognized opinion leaders and experts in the planning and execution of clinical trials in this therapeutic area. We will be seeking their advice in all phases of our clinical trial design." Potential CTXR Catalyst - FDA Response Citius Receives FDA Response on Pre-Investigational New Drug (PIND) Application for its Induced Mesenchymal Stem Cells (iMSCs) to Treat Acute Respiratory Distress Syndrome (ARDS) in Patients with CV-19 - FDA provides very specific guidelines to study iPSC-derived MSCs - Company intends to submit an IND application for its iMSC therapy for patients with ARDS associated with CV-19 CRANFORD, N.J., June 26, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products, announced today that the Company has received a written response from the U.S. Food and Drug Administration (FDA) in regards to its pre-investigational new drug (PIND) application for its induced mesenchymal stem cells (iMSCs) to treat and reduce the severity of acute respiratory distress syndrome (ARDS) in patients with CV-19. The FDA acknowledged that the Company could apply for fast track designation and also provided Citius with the chemistry, manufacturing, and control (CMC) requirements for the proposed trials. The Company plans to initiate actions on the FDA's recommendations and follow up with the FDA with an Investigational New Drug (IND) application under the C-virus Treatment Acceleration Program (CTAP). Myron Holubiak, Chief Executive Officer of Citius, commented, "We appreciate the FDA's thoughtful guidance on our unique, allogenic mesenchymal stem cells derived from induced pluripotent stem cells (iPSCs). We understand that iPSC-derived stem cells are not the same as adult-donor derived cells and, therefore, would require different proof of concept studies. Since we believe in the advantages of iPSC MSCs over donor-derived cells, we intend to develop assays recommended by the FDA and demonstrate the safety of these MSCs in our preclinical studies. We are committed to the successful completion of the required clinical trials to provide an effective and safe therapy for ARDS due to CV-19." ----- Potential CTXR Catalyst - [$7 Dawson James Price Target]( Here is valuation highlight from the Dawson James Securities updated October 2019 analyst report: Valuation. Our valuation is based on our therapeutic models and associated assumptions projected to 2030. Our model assumes multiple financial raises, and as such, our share count is based on a fully diluted out year basis. The lead product, MiniLok, is now in a Phase 3 trial. As such, we assume a 70% probability of success in our models. On top of this, we also use a 30% risk rate in our free cash flow to the firm (FCFF), our discounted EPS (dEPS) and sum-of-the-parts (SOP) models. We equal weight and average these metrics and then round to the nearest whole number to derive our $7.00 price target. ----- Potential CTXR Catalyst - [H.C. Wainwright $4 Target]( On August 18th, H.C. Wainwright analyst Vernon Bernardino reiterated his $4.00 price target on Citius Pharmaceuticals while maintaining a Buy rating. When you combine both the H.C. Wainwright target with the Dawson James Securities target, you get a weighted average target of $5.50. From CTXR's current trading levels at close Wednesday ($1.06), that gives the stock approximately 418% potential upside to that weighted target. ----- If there are any more updates this AM, I'll get them out to you quickly. Sincerely, Fierce Analyst | Jaks Swift Editorial Writer [Source]( I am not a licensed financial adviser. All potential percentage gains are based on from the low to the high of day. Fierce full disclosure is to be read and fully understood before using Fierce's website, or joining Fierce's email or text list. By viewing Fierce's website and/or reading Fierce's email or text newsletter you are agreeing to -> [( Stock Wire News (stock wire news . com) is owned by Stock News Wire LLC, a limited liability company. A member of Stock News Wire, LLC owns an interest in the limited liability company that owns and operates small cap firm . com (“SCF”), an interest in the limited liability company that owns and operates fierce investor . com (“FI”), an interest in the limited liability company that owns and operates stock street wire . com (SSW), and an interest in the limited liability company that owns and operates nasdaq wire news . com (NWN) . From time to time, Stock Wire News, SCF, FI, SSW, and/or NWN will publicly disseminate information about a company via website, email, SMS and other points of media. Pursuant to an agreement between Fierce Investor (FI) and StockWireNews LLC, FI was hired for a period beginning on 7/26/19 and ending on 7/29/19 to publicly disseminate information about (CTXR) via Website, Email and SMS. We were paid five thousand USD via bank check. We own zero shares of (CTXR). A member of StockWireNews LLC owns an interest in Fierce Investor. Pursuant to an agreement between StockWireNews LLC and Venado Media LLC, StockWireNews was hired for a period beginning on 7/26/19 and ending on 7/29/19 to publicly disseminate information about (CTXR) via Website, Email and SMS. We were paid twenty thousand USD via bank wire transfer. We own zero shares of (CTXR). Pursuant to an agreement between Fierce Investor (FI) and StockWireNews LLC, FI has been hired for a period beginning on 9/3/19 and ending on 9/4/19 to publicly disseminate information about (CTXR) via Website, Email and SMS. We have been paid five thousand USD via ACH. We own zero shares of (CTXR). In total, we have been compensated ten thousand USD via bank check and ACH to disseminate information about (CTXR). A member of StockWireNews LLC owns an interest in Fierce Investor. Pursuant to an agreement between StockWireNews LLC and Venado Media LLC, StockWireNews has been hired for a period beginning on 9/3/19 and ending on 9/4/19 to publicly disseminate information about (CTXR) via Website, Email and SMS. We were paid twenty thousand USD via bank wire transfer. We own zero shares of (CTXR). Pursuant to an agreement between Fierce Investor (FI) and StockWireNews LLC, FI has been hired for a period beginning on 12/18/19 and ending on 12/19/19 to publicly disseminate information about (CTXR) via Website, Email and SMS. We have been paid five thousand USD via ACH. We own zero shares of (CTXR). A member of StockWireNews LLC owns an interest in Fierce Investor. Pursuant to an agreement between StockWireNews LLC and Venado Media LLC, StockWireNews has been hired for a period beginning on 12/18/19 and ending on 12/19/19 to publicly disseminate information about (CTXR) via Website, Email and SMS. We were paid twenty thousand USD via bank wire transfer. We own zero shares of (CTXR). Pursuant to an agreement between Fierce Investor (FI) and StockWireNews LLC, FI has been hired for a one day period on 2/4/20 to publicly disseminate information about (CTXR) via Website, Email and SMS. We have been paid five thousand USD via ACH. We own zero shares of (CTXR). A member of StockWireNews LLC owns an interest in Fierce Investor. Pursuant to an agreement between StockWireNews LLC and Venado Media LLC, StockWireNews has been hired for a one day period on 2/4/20 to publicly disseminate information about (CTXR) via Website, Email and SMS. We were paid twenty thousand USD via bank wire transfer. We own zero shares of (CTXR). A member of StockWireNews LLC owns an interest in Fierce Investor. Pursuant to an agreement between StockWireNews LLC and Venado Media LLC, StockWireNews has been hired for a one day period on 3/11/20 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 Fierce Investor (FI) and StockWireNews LLC, FI 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 have been paid five thousand USD via ACH. We own zero shares of (CTXR). A member of StockWireNews LLC owns an interest in Fierce Investor. Pursuant to an agreement between StockWireNews 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 Fierce Investor (FI) and StockWireNews LLC, FI has been hired for a one day period on 4/28/20 to publicly disseminate information about (CTXR) via Website, Email and SMS. We have been paid seven thousand five hundred USD via ACH. We own zero shares of (CTXR). A member of StockWireNews LLC owns an interest in Fierce Investor. Pursuant to an agreement between StockWireNews 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). A member of StockWireNews LLC owns an interest in Fierce Investor. Pursuant to an agreement between StockWireNews 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 Fierce Investor (FI) and StockWireNews LLC, FI 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 have been paid three thousand five hundred USD via ACH. We own zero shares of (CTXR). In total, we have been compensated thirty-six thousand USD via bank check and ACH to disseminate information about (CTXR). A member of StockWireNews LLC owns an interest in Fierce Investor. Pursuant to an agreement between StockWireNews 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 Fierce Investor (FI) and StockWireNews LLC, FI 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 have been paid five thousand USD via ACH. We own zero shares of (CTXR). To date, we have been compensated forty-one thousand USD via bank check and ACH to disseminate information about (CTXR). A member of StockWireNews LLC owns an interest in Fierce Investor (FI). Pursuant to an agreement between StockWireNews 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). A member of StockWireNews LLC owns an interest in Fierce Investor (FI). Pursuant to an agreement between StockWireNews 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. We own zero shares of (CTXR). Pursuant to an agreement between Fierce Investor (FI) and StockWireNews LLC, FI has been hired for a two day period beginning on 9/17/20 and ending on 9/18/20 to publicly disseminate information about (CTXR) via Website, Email and SMS. We have been paid five thousand USD via ACH. We own zero shares of (CTXR). To date, we have been compensated forty-six thousand USD via bank check and ACH to disseminate information about (CTXR). A member of StockWireNews LLC owns an interest in Fierce Investor (FI). Pursuant to an agreement between StockWireNews LLC and Venado Media LLC, StockWireNews has been hired for a two day period beginning on 9/17/20 and ending on 9/18/20 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). To date, we have now been compensated two hundred and thirty thousand five hundred USD via bank wire transfer to disseminate information about (CTXR). Fierce | 539 W Commerce St, Dallas, TX 75208 [Unsubscribe {EMAIL}]( [Update Profile]( | [About our service provider]( Sent by jaks@fierceanalyst.net