Today's big breaking news could be a huge potential catalyst. Here's why...

SmallCapFirm

Past Champ Nasdaq Profile (CTXR) Could Be Be Gaining Breakout Steam After Today's Breaking News

Dawson James Securities - $8.00 Price Target

April 29th

SCF Members,

Today's big breaking news could be a huge potential catalyst. Here's why...

Right now, CTXR is trading around the $2.00 level which could have a bunch of potential resistance.

With this major news, if that level begins to breakdown, CTXR could be in line for a possible vertical surge back up the charts.

In case you haven't read it yet, here's the big press release:

Citius Pharmaceuticals Reports Strong Clinical Community Engagement During Mino-Lok® Phase 3 Trial-Related Webinar

Citius Pharmaceuticals leads discussion of Mino-Lok's potential to address biofilm and CLABSI challenges

Third webinar was the most well-attended in the Mino-Lok Series, drawing strong attendee interest from investigators, clinical trial staff and referring physicians

CRANFORD, N.J., April 29, 2021 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a specialty pharmaceutical company dedicated to the development and commercialization of critical care products with a focus on anti-infective products in adjunct cancer care, unique prescription products and stem cell therapy, today announced updates delivered during its third Mino-Lok® Phase 3 trial-related webinar. Mino-Lok®, the Company's lead product candidate, is an antibiotic lock therapy designed to salvage central venous catheters (CVCs) in patients with catheter related bloodstream infections (CRBSIs) or central line associated blood stream infections (CLABSIs). The webinar, led by Dr. Alan Lader, PhD, Vice President of Clinical Operations at Citius Pharmaceuticals was attended by investigators, clinical trial staff and referring physicians from trial sites participating in the Mino-Lok Phase 3 clinical trial.

[...]

"We believe Mino-Lok has the potential to become the gold standard in CRBSI/CLABSI care, and the first and only FDA approved treatment option for salvaging catheters in patients with CRBSI/CLABSI," added Myron Holubiak, President and Chief Executive Officer.

[...]

Read the full article here.

Between the bullish technicals CTXR is sporting right now and this news, it will be a profile to watch closely.

If you haven't read my initial report on this past champ, do so now and get it on your radar.

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Let's jump to it because the markets are open and you need to focus in now.

Previously, this profile churned out a mind-blowing move of over 150% (approx.) in the matter of a couple months.

Now, do to several potential driver indicators, this Nasdaq idea could be on the verge of its next possible breakout.

Citius Pharmaceuticals, Inc. (CTXR)

Citius is a late-stage specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives and cancer care.

Now, here's why CTXR should be your main focus today...

Citius Pharmaceuticals Is Addressing Several Unmet Needs In The Medical Field

Despite current medical advances, there are still many medical conditions with unmet needs. For example, long-term patients with Central Venous Catheters (CVCs) for dialysis or cancer treatment are still at risk for complications related to bloodstream infections that might be fatal.

Complications associated with CVC placement can present a 12%-25% morbidity and mortality, resulting in burdening hospitals and healthcare institutions with costs, hospital days, and patient quality of life. Thus, management and prevention should be the ultimate goal for positive treatment outcomes.

A company that understands the importance of unmet needs is Citius Pharmaceuticals, Inc. (NASDAQ: CTXR). The company is a specialty pharmaceutical company dedicated to developing and commercializing novel critical care drug products.

Citius is currently advancing three proprietary product candidates: Mino-Lok, CITI-002 (Halo Lido) and CITI-101 (Mino-Wrap). They also have therapy for treating ARDS, including ARDS associated with CV-19. This is what you need to know.

Citius In The Prevention Of Catheter-Related Bloodstream Infections (CRBSI) And Central Line-Associated Bloodstream Infections (CLABSI)

Infected catheters can become fatal, presenting patients with a host of new health problems, especially in cancer patients receiving therapy through central venous catheters (CVCs) and in hemodialysis patients where venous access presents a challenge.

Currently, there are no approved therapies to salvage infected CVCs, the standard treatment is removing and replacing (R&R) infected catheters. From the 7,000,000 CVCs used annually in the U.S., up to 472,000 become infected, leading to severe, life-threatening infections called CRBSI/CLABSI. Besides, it is important to acknowledge that hospitals are penalized for reporting high infection rates. The cost to R&R is around $10k. However, if the patients get an infection, the costs and potential patient harm increases significantly.

Through Citius novel therapy Mino-Lok solution, catheters can be disinfected and salvaged to prevent the need to replace and restart a deadly and costly process. Additionally, the market opp. for this therapy treatment is estimated at $750Mn per year in the U.S. and is projected to reach $1.84Bn globally in 2028.

Clinicians and technologists developed Mino-Lok at M.D. Anderson Cancer Center. Mino-Lok is currently being tested in a Phase 3 trial with the primary endpoint being catheter failures, and it has the potential to change the standard of care for the management of these severe infections.

Stem-Cell Therapy For Acute Respiratory Distress Syndrome (ARDS)

Another treatment being developed by Citius is stem-cell therapy for acute respiratory distress syndrome (ARDS) under the name Novellus. Matt Angel, Ph.D., CSO of the company, is working with mesenchymal stem cells (MSCs), which have been shown to be safe in over 900 clinical trials and in treating several inflammatory diseases, including ARDS.

ARDS is the most common cause of respiratory failure and mortality in CV-19 patients. Its symptoms include shortness of breath, rapid breathing, and bluish skin coloration. For those who survive, a decreased quality of life is common.

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Now that you have an idea of what's cooking with CTXR, here are its immediate potential driver indicators you need to know this moment:

Your No. 1 CTXR Potential Driver Indicator - Analyst Coverage With Major P.T.

Dawson James Securities - $8.00 Price Target

Here are the major highlights from the March Dawson James Securities updated analyst report:

Management is Focused and Understands. Now is the time to spend money on resources, FDA consultants and the like to ensure that all elements of the rolling NDA are up to par, from the culmination of component studies to CMC details, record keeping and, of course, a focus on the potential for the pivotal trial to be stopped early for efficacy.

What is Mino-Lok? Three active drug substances (minocycline, ethanol, and EDTA), which are combined into two vials, MLT01 (minocycline) and MLT02 (ethanol and EDTA). Citius has manufactured three registration lots of Mino-Lok using the commercial manufacturing process, part of the planned New Drug Application (NDA). Citius has placed all registration lots on stability at the appropriate ICH (The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) conditions to support the NDA filing. Citius has also developed a new exclusive synthesis process for disodium edetate, a chelating agent that supplants heparin as the anti-clotting agent in Mino-Lok.

Trial Background. 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. The current primary endpoint in the study 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 catheters that are associated with some serious adverse events.

Could the DMC halt the study early for Efficacy? We think so. This past September, the DMC recommended continuing the trial without any modifications. The DMC further requested to have an ad hoc meeting in the near future. Recall that the trial (Sept. 2019) reached the first interim analysis point of 37 catheter failures representing 40% of the anticipated events at ~58 patients. Recall that 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.

Valuation. Our valuation is based on our therapeutic models and associated assumptions projected to 2028. The lead product, MiniLok, is now in a Phase 3 trial. We conservatively assume just 50% probability of success in our therapeutic model. 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 $8.00 price target.

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From Wednesday's close, this $8.00 price target provides upside potential over 300%.

Now, I'm not saying CTXR is going to go soaring to $8.00 today, but you need to be aware of this analyst provided potential upside.

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Your No. 2 CTXR Potential Driver Indicator - Bullish Technicals

According to Barchart at close Wednesday, CTXR is packing some seriously bullish technical indicators.

These are currently triggered as bullish:

Short Term Indicators

  • 20 Day Moving Average
  • 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
  • 100 - 200 Day MACD Oscillator

With all of these bullish technical indicators, Barchart is reporting CTXR to be an "88% BUY" based on overall technicals with a "100% BUY" in the medium and long term.

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Your No. 3 CTXR Potential Driver Indicator - Chart Could Be Heating Up / Trading From Possible Support

Take a look at CTXR's 6-month chart:

image

Can you see how hot CTXR has been over the past week? Could this be the start of a major move?

In recent days, CTXR has has been on a heater and testing $2.00 resistance.

At this moment, CTXR is trading above 4 key lines of potential support:

  • 5-Day Exponential Moving Average (EMA)
  • 13-Day Exponential Moving Average
  • 50-Day Simple Moving Average (SMA)
  • 200-Day Simple Moving Average

Why is this important? When a profile trades above these 4 lines, people may gain confidence from these levels holding as potential support for a continued vertical surge.

Plus, CTXR's 5-Day EMA is trading above its 13-Day EMA which signals a profile trending in the right direction.

Could we see a continuation of this recent burst today?

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Your No. 4 CTXR Potential Driver Indicator - Shareholder Letter/Corporate Update

Citius Pharmaceuticals Issues Shareholder Letter with Corporate Update on Recent Achievements and Anticipated Milestones for 2021

-2021 Expected to be a Banner Year for Advancing Three Product Platforms in the Clinic:

-Mino-Lok® Interim Efficacy Analysis

-Halo-Lido filing IND and in Phase 2b trial

-Mino-Wrap™ in Pre-Clinical Development, targeting IND by end of year

-NoveCite subsidiary progressing with: continued data collection from an ongoing proof-of-concept sheep ARDS model; initiating the manufacture of clinical-grade induced-mesenchymal stem cells (i-MSCs); and implementation of FDA

-required animal GLP toxicology studies

CRANFORD, N.J., Feb. 16, 2021 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a specialty pharmaceutical company developing and commercializing critical care drug products, today issued a shareholder letter providing a corporate update on the Company's recent achievements and anticipated milestones for 2021.

Highlights from the letter include:

  • Mino-Lok® pivotal trial interim analysis and review by the Data Monitoring Committee (DMC) expected in the second quarter
  • Halo-Lido IND (second quarter) and Phase 2b protocol to be filed afterwards
  • Mino-Wrap™ in pre-clinical development with plans to submit IND to the FDA by the end of the year
  • NoveCite i-MSCs development is progressing with: ongoing data generation from our proof-of-concept sheep acute respiratory distress syndrome (ARDS) model demonstrating impressive interim results (studies to be completed in second quarter); FDA-required GLP animal toxicology studies have been implemented; and development of an i-MSC master cell bank (MCB) followed by cGMP manufacturing is underway
  • Private placement for gross proceeds of $20Mn and investors' exercise of warrants generating $4.5Mn in gross proceeds completed in January 2021 and February 2021, respectively

"Our important achievements against the CV-19 headwinds last year give us great confidence that 2021 will be a banner year for advancing our three product platforms in the clinic, and our corporate decision to commence the development of NoveCite next-generation cellular therapies further expands our goal as a specialty pharmaceutical company dedicated to the development and commercialization of therapeutic products for significant unmet medical needs," said Myron Holubiak, President and CEO of Citius Pharmaceuticals.

Read the full article here.

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Recap: Top 4 Potential CTXR Driver Indicators

#1. Analyst Coverage With Major P.T.

#2. Bullish Technicals

#3. Chart Could Be Heating Up / Trading From Possible Support

#4. Shareholder Letter/Corporate Update

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Coverage is officially initiated on CTXR. Also, when you have a moment later on, do this:

image

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If there are any more updates today, I'll get them out to you quickly.

Sincerely,

Axel Adams

Editor, SCF


Source


(Always Remember The Stock Prices Could Be Significantly Lower Now From The Dates I Provided.)​

Disclosure: Make sure to always do your own research and due diligence on any day and swing trade profile I bring to your attention. I am not a license d finan.cial advise r. All potential percentage gains are based on from the low to the high of day. SmallCapFirm's full disclosure is to be read and fully understood before using SmallCapFirm's website, or joining SmallCapFirm's email or text list. By viewing SmallCapFirm's website and/or reading SmallCapFirm's email or text newsletter you are agreeing to SmallCapFirm's full disclosure which can be read at: smallcapfirm.com/disclosure StockWireNews (stockwirenews . com) is owned by StockNewsWire LLC, a limited liability company. 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Pursuant to an agreement between StockNewsWire 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 SmallCapFirm and StockNewsWire LLC, SmallCapFirm was 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 bank wire transfer. We own zero shares of (CTXR). An owner of StockNewsWire LLC owns an interest in SmallCapFirm. Pursuant to an agreement between StockNewsWire 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 SmallCapFirm and StockNewsWire LLC, SmallCapFirm was 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 bank wire transfer. We own zero shares of (CTXR). An owner of StockNewsWire LLC owns an interest in SmallCapFirm. Pursuant to an agreement between StockNewsWire 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). An owner of StockNewsWire LLC owns an interest in SmallCapFirm. Pursuant to an agreement between StockNewsWire 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 SmallCapFirm and StockNewsWire LLC, SmallCapFirm was 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 bank wire transfer. We own zero shares of (CTXR). An owner of StockNewsWire LLC owns an interest in SmallCapFirm. 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 SmallCapFirm and StockNewsWire LLC, SmallCapFirm 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 five thousand USD via bank wire transfer. We own zero shares of (CTXR). An owner of StockNewsWire LLC owns an interest in SmallCapFirm. 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) An owner of StockNewsWire LLC owns an interest in SmallCapFirm. 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 SmallCapFirm and StockNewsWire LLC, SmallCapFirm 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 bank wire transfer. We own zero shares of (CTXR). An owner of StockNewsWire LLC owns an interest in SmallCapFirm. 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 SmallCapFirm and StockNewsWire LLC , SmallCapFirm 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 bank wire transfer. We own zero shares of (CTXR). An owner of StockNewsWire LLC owns an interest in SmallCapFirm (SCF). 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). An owner of StockNewsWire LLC owns an interest in SmallCapFirm (SCF). 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. We own zero shares of (CTXR). Pursuant to an agreement between SmallCapFirm and StockNewsWire LLC, SmallCapFirm 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 bank wire transfer. We own zero shares of (CTXR). An owner of StockNewsWire LLC owns an interest in SmallCapFirm (SCF). Pursuant to an agreement between StockNewsWire 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). An owner of StockNewsWire LLC owns an interest in SmallCapFirm (SCF). Pursuant to an agreement between StockNewsWire LLC and Legends Media, LLC, StockWireNews has been hired for a one day period beginning on 10/6/20 to publicly disseminate information about (CTXR) via Website, Email and SMS. We have been paid ten thousand USD via bank wire transfer. We own zero shares of (CTXR). An owner of StockNewsWire LLC owns an interest in SmallCapFirm (SCF). Pursuant to an agreement between StockNewsWire LLC and Legends Media, LLC, StockWireNews has been hired for an additional one day period beginning on 10/8/20 to publicly disseminate information about (CTXR) via Website, Email and SMS. We have been paid two thousand five hundred USD via bank wire transfer. We own zero shares of (CTXR). Pursuant to an agreement between SmallCapFirm and StockNewsWire LLC, SmallCapFirm has been hired for a one day period beginning on 12/8/20 to publicly disseminate information about (CTXR) via Website, Email and SMS. We have been paid ten thousand USD via bank wire transfer. We own zero shares of (CTXR). An owner of StockNewsWire LLC owns an interest in SmallCapFirm (SCF). Pursuant to an agreement between StockNewsWire LLC and Legends Media, LLC, StockWireNews has been hired for an additional one day period beginning on 12/8/20 to publicly disseminate information about (CTXR) via Website, Email and SMS. We have been paid sixty-seven thousand five hundred USD via bank wire transfer. We own zero shares of (CTXR). An owner of StockNewsWire LLC owns an interest in SmallCapFirm (SCF). Pursuant to an agreement between StockNewsWire LLC and Legends Media, LLC, StockWireNews has been hired for a period beginning on 2/16/21 and ending on 2/17/21 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 SmallCapFirm and StockNewsWire LLC, SmallCapFirm has been hired for a period beginning on 4/29/21 and ending on 4/30/21 to publicly disseminate information about (CTXR) via Website, Email and SMS. We have been paid twenty thousand USD via bank wire transfer. We own zero shares of (CTXR). To date, we have been compensated seventy-three thousand five hundred USD via bank check and bank wire transfer to disseminate information about (CTXR). This twenty thousand USD has been used for past marketing and advertising and will be used for future marketing and advertising on companies listed below and new companies on an ongoing basis. All companies will be disclosed. An owner of StockNewsWire LLC owns an interest in SmallCapFirm (SCF). Pursuant to an agreement between StockNewsWire LLC and Legends Media, LLC, StockWireNews has been hired for a period beginning on 4/29/21 and ending on 4/30/21 to publicly disseminate information about (CTXR) via Website, Email and SMS. We have been paid ninety-five thousand USD via bank wire transfer. We own zero shares of (CTXR). To date, we have now been compensated four hundred and twenty-three thousand USD via bank wire transfer to disseminate information about (CTXR). This ninety-five thousand USD has been used for past marketing and advertising and will be used for future marketing and advertising on companies listed below and new companies on an ongoing basis. All companies will be disclosed. Pursuant to an agreement between SmallCapFirm (SCF) and StockNewsWire LLC, SCF has been hired for a period beginning on 4/26/21 and ending on 4/27/21 to publicly disseminate information about (XXII) via Website, Email and SMS. We have been paid twenty thousand USD via bank wire transfer. We own zero shares of (XXII). An owner of StockNewsWire LLC owns an interest in SmallCapFirm (SCF). Pursuant to an agreement between StockNewsWire LLC and Legends Media LLC, StockWireNews has been hired for a period beginning on 4/26/21 and ending on 4/27/21 to publicly disseminate information about (XXII) via Website, Email and SMS. StockNewsWire LLC was paid ninety-five thousand USD via bank wire transfer. StockWireNews owns zero shares of (XXII).