$CTXR “Fierce Analyst” Promoter Rank: 30/34 Citius Pharmaceuticals Inc. Newsletter 7:00:44 PM August 4, 2020

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CTXR Promotional Newsletter

The following is a newsletter released by "Fierce Analyst" promoting Citius Pharmaceuticals Inc.

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NASDAQ Past Champ CTXR Displays A Bullish Chart And Technicals - Must Read Now

Two Different Analysts Provide Price Targets With Over 100% Potential Upside For CTXR

August 4th, 2020
FierceAnalyst Member,

The market is officially closed. It's time to look forward to what could transpire in the short-term for a new idea, and past champ, Citius Pharamceuticals, Inc. CTXR.

Previously, I brought this profile to your attention on June 3rd at approximately 930AM 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%.

I'm not lying. Take a look at CTXR's 6-month chart

As you can see, this profile has been on steady ascension up the charts since mid-March.

Even better, over the past week or so, CTXR has maintained the same general levels between $1.23 - $1.36.

With CTXR holding strong at this level, this could be important support for its next major move up the chart

Could That Move Be Right Around The Corner

Well, according to , CTXR is displaying several bullish technical indicators that could be signalling a potential breakout in the near future.

Additionally, the website is reporting CTXR to be an 88% BUY based on overall technical indicators.

Indicators Are Useful, But Here's The Thick Of It...

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 stock 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.

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 - Positive FDA Feedback

Citius Receives Positive FDA Feedback on Its Submitted Plan to Study Catheter Compatibility for Mino-Lok Therapy

- Compatibility plan includes testing representative samples of all commercially available CVCs and PICCs

- Plan is designed to be conducted in parallel with the completion of the Phase 3 pivotal trial

- Targeted worldwide market for Mino-Lok is expected to reach $1.84Bn by 2028

CRANFORD, N.J., June 2, 2020 PRNewswire -- Citius Pharmaceuticals, Inc. Citius or the Company Nasdaq CTXR, a specialty pharmaceutical company focused on developing and commercializing critical care drug products, today announced that it has received positive feedback from the Food and Drug Administration FDA on its proposed catheter compatibility studies for the Company's Mino-Lok therapy. The studies, if and when successfully completed, should allow Mino-Lok to be labeled for use with all commercially available central venous catheters CVCs and peripherally inserted central catheters PICCs on the U.S. market. It is further assumed that these studies will meet European and world standards.

The ability to be labeled without restrictions with respect to catheter type would allow Mino-Lok unrestricted access to the full U.S. and world markets for an effective antibiotic lock therapy for central line-associated bloodstream infections CLABSIs, which are estimated to be over $1.5Bn per year worldwide. The catheter compatibility studies will be conducted in parallel with the completion of the ongoing Phase 3 clinical study. The Company announced in early February 2020 that this pivotal trial had reached the halfway point for enrollment. The next milestone in the trial is the result of an interim efficacy analysis, which is expected to occur in the second half of 2020.

We believe we continue to check all the boxes required for an NDA submission, commented Myron Holubiak, Chief Executive Officer of Citius. According to our planned dosing recommendations, the Mino-Lok solution dwells in the catheter for two hours per day for 5 to 7 days. This would be between 10 to 14 hours of aggregate, but intermittent, exposure time of the catheter to Mino-Lok. We believe that this exposure is far lower than what is recommended for home-brewed antibiotic lock solutions, which should lead to less intrusive therapy and fewer days on therapy for patients.

The shorter dwell time for Mino-Lok also means that the catheter is available for its intended purpose, allowing treatment for the underlying disease to continue. Additionally, and more importantly, our pivotal trial is designed to show the superiority of Mino-Lok to standard antibiotic locks in time-to-catheter-failure. If all these studies prove to be successful, we believe ready-to-use Mino-Lok will be superior to home-brewed antibiotic locks in both efficacy and dosing schedules, Mr. Holubiak concluded.

Mino-Lok is an antibiotic lock solution used to treat patients with CLABSIs and catheter-related bloodstream infections CRBSIs in combination with an appropriate systemic antibiotics to preserve central venous access and to avoid the complications and morbidities associated with catheter removal and reinsertion procedures. It has the potential to change the standard of care, which currently calls for a procedure to remove and replace the infected catheter. Each year, up to 500,000 CVCs of the 7 million used become infected and lead to CLABSIs, increasing both patient morbidity risk and costs to the medical system. It has been shown that antibiotics alone are unable to penetrate the biofilm caused by bacteria, and there are currently no approved therapies for salvaging infected central venous catheters. According to DelveInsight, the market size of CLABSIs and closely associated CRBSIs in the global market is expected to reach $1.84Bn in 2028, up from $1.24Bn in 2017.

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Potential CTXR Catalyst -

Here are some of the highlights from the Dawson James Securities updated October 2019 analyst report

First Interim Reached Citius announced that the first interim analysis point 37 catheter failures, which represents 40% of the anticipated events at 58 patients has been reached. The DSMB will now review the data and come back with analysis in about six weeks. We see the most likely recommendation being that the trial continues, unchanged. The DSMB could recommend increasing the trial add statistical power to see the signal with a p-value. The trial is designed with 80% power for an assumed 17 day difference between active and standard of care SOC. We typically expect the SOC arm to fail in 5-14 days.

Second Interim Analysis Superiority. At 69 events, or 75% of the total events anticipated at 108 patients, the DSMB will again review the trial. In this second analysis efficacy will be evaluated.

The FDA says Go For it. The FDA responded to the Company's proposal to refine the endpoints in the current Phase 3 pivotal trial for Mino-Lok. As a reminder, the current Phase 3 trial being conducted compares Mino-Lok therapy MLT to the standard of care, which is antibiotic lock therapy ALT. This is used to disinfect colonized catheters causing bacteremia and keep the treated catheters functioning and infection-free for eight weeks post-therapy.

New Endpoint Saves Time and Money. The new proposed primary endpoint is planned to demonstrate a significant difference in the time to catheter failure when comparing MLT to ALT. This is clinically important because eliminating the source of infection enables antibiotic treatment of the bacteremia to work more effectively and expeditiously. Additionally, if a catheter can be maintained for the time that it is needed, the patient does not need to be subjected to the procedures for removing and replacing the catheter that are associated with some serious adverse events. Citius believes that the change to the primary endpoint will result in fewer than 150 total subjects in Phase 3 trial and significant cost savings up to $10M.

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.

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Potential CTXR Catalyst -

Back On January 24th, H.C. Wainwright analyst Vernon Bernardino raised the price target on Citius Pharmaceuticals to $4.00 from $1.65 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 around approximately $1.31 Tuesday 1200PM EST, that gives the stock approximately 319% potential upside.
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Before Wednesday's opening bell, make sure to get CTXR on your radar.

Sincerely,
Fierce Analyst Jaks Swift
Editorial Writer

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 andor reading Fierce's email or text newsletter you are agreeing to -

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Pursuant to an agreement between Fierce Investor FI and StockWireNews LLC, FI was hired for a period beginning on 72619 and ending on 72919 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 72619 and ending on 72919 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 9319 and ending on 9419 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 9319 and ending on 9419 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 121819 and ending on 121919 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 121819 and ending on 121919 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 2420 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 2420 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 31120 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 4220 and ending on 4320 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 4220 and ending on 4320 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 42820 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 42820 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 51320 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 6220 and ending on 6320 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 6220 and ending on 6320 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 7720 and ending on 7820 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 7720 and ending on 7820 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.

Fierce Investor FI has not been compensated for the 8420 to 8520 profile of CTXR. 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 8420 and ending on 8520 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. To date, we have now been compensated two hundred and three thousand USD via bank wire transfer to disseminate information about CTXR.

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