StockWireNews
(CTXR) Continues To Heat Up, Hits New Day High And Could Be Entering Breakout Mode
Dawson James Securities - $8.00 Price Target
June 16th
Good Morning,
Have you kept CTXR on your radar?
Hitting a high of $3.34 just moments ago, CTXR could be lining up for a major 2nd half to this hump day.
With a swing from a low of $2.95 to this $3.34 high, CTXR has now made a move of approximately 13% intraday.
Trading at the top right of its chart and making a new 52-week high, CTXR will be one to watch closely the rest of the day.
Drop what you're doing to read my initial report below and get CTXR on your screen now.
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The opening bell is now behind us so there's absolutely no time to waste.
Back at the end of April, I brought this profile to you on the 29th at 9:30AM EST. That day it opened at $1.99.
Fast forward just over a month and a half later and here it is on Tuesday hitting a new 52-week high of $3.29.
Overall, that surge resulted in a move of approximately 65%.
Now, do to several potential driver indicators, this Nasdaq idea could be on the verge of its next possible breakout.
Here's why Citius Pharmaceuticals, Inc. (CTXR) needs immediate attention again...
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, pay close attention...
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 - Company Being Added To Russell 2000® Index
Citius Pharmaceuticals to be Added to Russell 2000® Index
CRANFORD, N.J., June 7, 2021 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products with a focus on anti-infective products in adjunct cancer care, unique prescription products and stem cell therapy, today announced that it is set to be added to the Russell 2000® Index at the conclusion of the Russell US Indexes annual reconstitution, effective at the opening of the U.S. equity markets on June 28, 2021.
"Our inclusion in the Russell index is an important milestone for Citius that reflects the continued progress we are making to develop and commercialize first-in-class treatment options for patients around the world. We welcome the enhanced visibility of our diversified pipeline and long-term growth potential, and look forward to sharing our future milestones with a broader investment community," said Myron Holubiak, President and Chief Executive Officer of Citius.
FTSE Russell determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes. Membership in the small-cap Russell 2000® Index, which remains in place for one year, is based on membership in the broad-market Russell 3000® Index. Citius st-ock will also be automatically added to the appropriate growth and value indexes.
Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $9Tn in assets are benchmarked against Russell's US indexes. Russell indexes are part of FTSE Russell, a leading global index provider.
Read the full article here.
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Your No. 2 CTXR Potential Driver Indicator - Achieving Key Mino-Lok Phase 3 Trial Milestone
Citius Pharmaceuticals Achieves Next Interim Analysis Milestone in its Mino-Lok® Phase 3 Trial
- Independent Data Monitoring Committee (DMC) to review Mino-Lok® safety, superiority, and futility data at upcoming meeting scheduled for June 29, 2021
CRANFORD, N.J., June 8, 2021 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products with a focus on anti-infective products in adjunct cancer care, unique prescription products and stem cell therapy, today announced that the next planned interim analysis in its Phase 3 trial of Mino-Lok®, an antibiotic lock solution for the treatment of patients with catheter-related blood stream infections (CRBSIs/CLABSIs) has been scheduled for the end of June 2021. In accordance with the independent Data Monitoring Committee (DMC) charter, the DMC will hold a meeting to review the trial data for safety, superiority and futility.
"We look forward to feedback from the DMC following their review of the trial data," stated Myron Holubiak, President and Chief Executive Officer of Citius.
According to the Mino-Lok® Phase 3 study protocol, the DMC is responsible for conducting interim analyses when 40%, 50% and 65% of the total number of anticipated events have been observed. The first two interim analyses were conducted by the DMC in 2019 and 2020, respectively. The next interim analysis meeting of the DMC will be held on June 29, 2021. At that time, the DMC will review unblinded study data and subsequently provide written recommendations to Citius within five business days.
The Mino-Lok® Phase 3 pivotal superiority trial is a multi-center, randomized, open-label, blinded study to determine the efficacy and safety of Mino-Lok® (MLT), a novel antibiotic lock therapy that combines minocycline with edetate disodium. The primary endpoint for this study is the time (in days following randomization) to a catheter failure event between randomization and TOC (Week 6) in the Intent-to-Treat (ITT) Population.
Approximately 144 subjects diagnosed with CRBSI/CLABSI and who meet all necessary criteria for the study are randomized in a 1:1 ratio to receive either Mino-Lok® therapy or standard of care antibiotic lock therapy. To date, the Company has achieved more than 80% of the expected enrollment.
Subjects in the Mino-Lok® arm receive one MLT dose daily with a dwell time of two to four hours for a total of seven doses. For subjects in the Control arm, the investigator determines the antibiotic used in the lock, dose, dwell time, and number of days of administration based on institutional standards or Infectious Diseases Society of America (IDSA) guidelines.
Read the full article here.
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Your No. 3 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 Tuesday's close, this $8.00 price target provides upside potential over 150%.
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. 4 CTXR Potential Driver Indicator - Bullish Technicals
According to Barchart at close Tuesday, CTXR is packing some seriously bullish technical indicators.
These are currently triggered as bullish:
Short Term Indicators
- 20 Day Moving Average
- 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
- 100 - 200 Day MACD Oscillator
With all of these bullish technical indicators, Barchart is reporting CTXR to be an "100% BUY" based on overall technicals with a "100% BUY" in the short, medium, and long term.
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Your No. 5 CTXR Potential Driver Indicator - Red Hot Chart / Trading Above Possible Strong Support
Take a look at CTXR's 6-month chart:
