Big Breaking News Has Today's Profile (Inside) Trending Green, Read Immediately
Analyst Price Targets For (CTXR) - $5.50 Weighted Target
Wow. Huge news out of the CTXR camp has this past champ trending green. Read Now:
Citius Pharmaceuticals Subsidiary NoveCite Announces Data from a Study of Induced Mesenchymal Stem Cell ("i-MSC") Therapy in an in vivo Model of Acute Respiratory Distress Syndrome ("ARDS")
--Interim results indicate i-MSC therapy improves oxygenation and reduces lung injury
--Efficiently manufactured higher potency mesenchymal stem cells offer promising therapeutic approach
CRANFORD, N.J., Dec. 8, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a specialty pharmaceutical company developing and commercializing critical care drug products, today announced interim data from a proof-of-concept ("POC") large animal study of its proprietary induced mesenchymal stem cell ("i-MSC") therapy for acute inflammatory respiratory conditions including CV-19 related Acute Respiratory Distress Syndrome ("ARDS"). The available results of i-MSC therapy in the study show improvement in critical parameters, such as improved oxygenation, less systemic shock, and reduced lung injury, compared to the control group. The study was conducted in a widely accepted large animal model.
Read The Full Article Here.
If you haven't read my initial report below, do so now and get CTXR on your radar before it's too late.
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%.
CTXR could be on the verge of a new major breakout due to this huge potential driver indicator news that dropped last week:
Citius Pharmaceuticals to Present Corporate Update at Benzinga Global Small Cap Conference on December 8
Now, at first glance this may not seem like big news, but here are the key takeaways from the article:
[The company is] currently advancing four proprietary product candidates: Mino-Lok®, CITI-002 (halobetasol-lidocaine formulation or Halo-Lido), CITI-101 (Mino-Wrap), and CITI-401 (iMSC). Mr. Mazur will discuss recent Company developments for these product candidates including:
- Mino-Lok® is advancing in its Phase 3 trial
- A positive second interim analysis report from the independent Drug Monitoring Committee (DMC) for the Mino-Lok pivotal Phase 3 trial
- The signing of an exclusive worldwide license agreement with Novellus Therapeutics, Limited for a cellular therapy to treat acute respiratory distress syndrome (ARDS), a leading complication of CV-19; and the formation of our Novecite, Inc. subsidiary.
- Submission of a pre-investigational new drug (PIND) consultation request for Mino-Wrap with written response and guidance is expected
- Update on Halo-Lido which is anticipated to begin Phase 2b trial in the first quarter of 2021
Could this corporate update today bring serious buzz to CTXR?
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.
CTXR Potential Driver Indicator - Mino-Lok Study
Citius Announces Results of Study that Mino-Lok Eradicates S. aureus Biofilm More Effectively and Expeditiously than Components
-- Mino-Lok superior to EDTA and Ethanol in eradicating most worrisome pathogen
-- Two strains of resistant Staphylococcus aureus tested
-- Study reinforces previous studies that all three components needed for some biofilm forming pathogens
CRANFORD, N.J., Nov. 30, 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 the completion of a Boston Analytical study "Silicone Disk Method for In Vitro Assessment of Antimicrobial Activity Against Resistant Staphylococcal Biofilms by Minocycline-EDTA-Ethanol and EDTA-Ethanol Lock Solutions." This study demonstrated that all three components of Mino-Lok (30 mg/mL EDTA, 19.5% ethanol and 1 mg/mL minocycline) were superior to EDTA/ethanol (30 mg/mL EDTA and 19.5% ethanol). There were two strains of Staphylococcus aureus used for the inocula and two samples of each strain were tested as four reference groups. The test solutions were examined following incubation for the following three time points: 60 minutes; 90 minutes; and 120 minutes. The Colony Forming Units (CFU)/Disk value was assessed from 10 disks at each time-point for each group. The results indicate that when the exposure time is 60 minutes, the number of CFU/Disk under the MLT group is significantly smaller than the number of CFU/Disk under the EDTA/ethanol group in one strain and very close to significance (p-value = 0.0598) in the second strain. For all exposure times, the number of CFU/Disk was always lower in the MLT treated disks compared to the EDTA/ethanol treated disks.
The researchers concluded that "… taken together, the results suggest that MLT can eradicate the biofilm quicker than EDTA/ethanol."
"Staph aureus is one of the most worrisome pathogens in catheter related bloodstream infections (CRBSI). This pathogen receives special consideration even in the IDSA guidelines for treating CRBSI. We are very pleased to show that Mino-Lok appears to be more effective, and work more expeditiously, than even ethanol," commented Myron Holubiak, Chief Executive Officer of Citius. "It has been demonstrated in earlier studies and reports that all three components of Mino-Lok are necessary to eradicate MRSA and Candida parapsilosis. More recently we showed that MLT was effective in vitro against 10 strains of Candida Auris. All of these pathogens are of great concern in cancer patients with central lines. As we approach the final stages of our pivotal trial, we are very excited to be able to report new findings about Mino-Lok. 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 local pharmacy mixed antibiotic locks in both efficacy and dosing schedules."
Mino-Lok 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 catheter-related bloodstream infections (CRBSIs) in the global market is expected to reach $1.84Bn in 2028, up from $1.24Bn in 2017.
CTXR Potential Driver Indicator - October Shareholder Update
Citius Pharmaceuticals Issues October 2020 Letter to Shareholders
-- Company recently licensed cellular therapy for potential treatment of ARDS associated with CV-19
-- Mino-Lok, Company's lead product, is progressing through Phase 3 trials and, if approved, is positioned for market entry into an estimated $1.5Bn market
-- Phase 2b trial for Halo-Lido hemorrhoid treatment expected to begin Q1 2021
CRANFORD, N.J., Oct. 27, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ: CTXR), a specialty pharmaceutical company developing and commercializing critical care drug products, announced that it has issued an October 2020 Letter to Shareholders. The letter addresses recent updates on the Company's business and clinical developments and news for its pipeline of products.
Recent highlights include:
- The signing of an exclusive worldwide license agreement with Novellus Therapeutics, Limited for a cellular therapy to treat acute respiratory distress syndrome (ARDS), a leading complication of C-19
- Received positive second interim analysis report from the independent Drug Monitoring Committee (DMC) for the Mino-Lok pivotal Phase 3 trial
- Submission of a pre-investigational new drug (PIND) consultation request for Mino-Wrap with written response and guidance from the FDA expected in November of 2020
- Completed patient survey for Halo-Lido to develop a patient reported outcome (PRO) instrument with plans set to begin Phase 2b trial in the first quarter of 2021
"While the C-19 pandemic has affected patient recruitment in almost all clinical trials, including our own, I'm proud that the Company has continued to make significant progress across our entire pipeline," said Myron Holubiak, Chief Executive Officer of Citius. "Our focus and movement with these projects demonstrate the value we're intent on building for shareholders, and I look forward to sharing more developments in the future."
CTXR Potential Driver Indicator - Positive News From New Subsidiary
Novellus Therapeutics Exclusively Licenses Induced Mesenchymal Stem Cells (iMSCs) to NoveCite for CV-19 Related Acute Respiratory Distress Syndrome (ARDS) and Other Acute Respiratory Conditions
-Novellus's iMSCs are derived from a single donor using its patented mRNA-based, footprint-free cell reprogramming technology
- iMSCs overcome the significant challenges of limited supply and low potency associated with donor-derived MSCs
CAMBRIDGE, Mass., Oct. 13, 2020 /PRNewswire/ -- Novellus Therapeutics ("Novellus"), an engineered cellular medicines company, announced today that it has licensed its induced mesenchymal stem cells (iMSCs) on a worldwide basis to NoveCite, Inc., a newly formed subsidiary of Citius Pharmaceuticals, Inc. ("Citius") (Nasdaq: CTXR), a specialty pharmaceutical company focused on developing and commercializing critical care drug products. NoveCite will develop and commercialize Novellus's iMSCs to treat acute respiratory conditions with a near term focus on Acute Respiratory Distress Syndrome ("ARDS") associated with C19. Novellus is a 25% equity holder in NoveCite. Novellus received a $5Mn upfront payment, and is eligible to receive up to $51Mn in development milestone payments, as well as low double-digit royalties.
Novellus Therapeutics Exclusively Licenses Induced Mesenchymal Stem Cells (iMSCs) to NoveCite
iMSCs are a next-generation cell therapy product created from induced pluripotent stem cells (iPSCs) with the following advantages:
- Created using a patented non-immunogenic mRNA cell reprogramming process
- Derived from a single donor and produced from a clonal, perpetual master cell bank
- Streamlined manufacturing process enables near-unlimited supply
- Superior immunomodulatory protein secretion compared to donor-derived MSCs
"Novellus's iMSCs have the potential to be a breakthrough in the field of cellular therapy for acute respiratory conditions because of their high potency as demonstrated in our pre-clinical studies, as well as our ability to cost-effectively provide high doses and repeat doses." said Myron Holubiak, CEO of Citius.
"We are excited to be developing iMSCs because of their promise to save lives and reduce long term sequelae in patients with devastating respiratory diseases such as ARDS caused by C-19," said Matt Angel, Chief Science Officer of Novellus. He continued, "Our iMSCs have multimodal immunomodulatory mechanisms of action that make them promising for treatment of acute respiratory diseases."
CTXR Potential Driver Indicator - Technical Indicators
According to Barchart's website, this profile has multiple technical indicators that have been triggered as bullish (as of close Monday):
Short Term Indicators
- 20 Day Moving Average
- 20 - 200 Day MACD Oscillator
Medium Term Indicators
- 50 Day Moving Average
- 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 the addition of Barchart's "TrendSpotter" composite technical indicator, could this be the signal of a major vertical move for CTXR right around the corner?
CTXR Potential Driver Indicator - $7 Dawson James P.T.
Here is the major highlight from the November Dawson James Securities updated analyst report:
Valuation. Our valuation is based on our therapeutic models and associated assumptions projected to 2028. Our model assumes multiple financial raises, and as such, our share count is based on a fully diluted out year basis. The lead product, Mini-Lok, is now in a Phase 3 trial. We conservatively assume just 50% 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.
CTXR Potential Driver Indicator - H.C. Wainwright $4 P.T.
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 Monday ($1.15), that gives the stock approximately 378% potential upside to that weighted target.
CTXR Recap - Key Potential Driver Indicators
#1. Today's Corporate Update Presentation
#2. Results Of Recent Mino-Lok Study
#3. October's Shareholder Update
#4. Positive News From New Subsidiary, NoveCite
#5. Bullish Technical Indicators
#6. Consensus $5.50 Analyst Price Target