Breaking News Today Could Bring Serious Attention To Nasdaq Past Champ (CTXR), Key Details Now
Dawson James Securities - $8.00 Price Target
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.
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.
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.
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.
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.
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: