New NASDAQ Pharma Stock Profile (CTXR) Just Dropped Major Game-Changing News
Dawson James Securities Provides $7.00 Analyst Price Target
DJS Analyst Report
There's no time to waste today. My last NASDAQ stock profile ran approximately 105% intraday. Now it's time to pay close attention...
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 new NASDAQ profile, Citius Pharmaceuticals, Inc. (CTXR), such an exciting stock in the short-term.
Check Out Yesterday's Major CTXR News Release
Citius Signs Exclusive Option with Novellus to License Novel Stem-Cell Therapy for Acute Respiratory Distress Syndrome (ARDS) Associated with CV-19
- Novellus's patented mRNA-based cell-reprogramming technology creates unique mesenchymal stem cells (MSCs) with superior immunomodulatory properties and manufacturing advantages over primary adult donor-derived MSCs - much greater supply and faster scale-up
- MSCs prevent and suppress cytokine storm believed to be the cause of the severe inflammation of ARDS and now seen in CV-19 patients
CRANFORD, N.J., April 1, 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 signed an exclusive six-month option agreement to in-license a stem-cell therapy for acute respiratory distress syndrome (ARDS) from a subsidiary of Novellus, Inc., a preclinical-stage biotechnology company based in Cambridge, MA.
Novellus's patented process uses its exclusive non-immunogenic synthetic messenger ribonucleic acid (mRNA) molecules to create induced pluripotent stem cells (iPSCs) that, in turn, generate mesenchymal stem cells (MSCs) with superior immunomodulatory properties. MSCs have been shown to be safe in over 900 clinical trials and to be safe and effective in treating a number of inflammatory diseases, including ARDS.
"ARDS is the most common cause of respiratory failure and mortality in CV-19 patients. Currently, there is no proven treatment for ARDS. Literature supports the use of counter-inflammatory MSCs for ARDS, and papers published in China have shown that at least seven CV-19 patients with ARDS responded to MSC therapy. Clearly this is an avenue that shows promise and should be pursued as a potential treatment for ARDS. We believe Novellus is at the forefront of creating allogeneic, iPSC-derived MSCs. These cells have the potential to overcome the limitations of MSCs derived from adult donors, which are telomere shortened and introduce variability into the manufacturing process," said Citius Chief Executive Officer Myron Holubiak.
Novellus Chief Science Officer Matt Angel, PhD, stated, "Using our mRNA-based cell-reprogramming technology, Novellus can provide a near-unlimited supply of MSCs for treating patients with ARDS, including those critically ill from CV-19. These will be allogeneic ('off-the-shelf') cells that in vitro have demonstrated much greater expansion potential and much higher immunomodulatory protein expression than donor-derived MSCs. We are excited to employ our technology to such an urgent medical crisis and believe that our MSCs represent an ideal source of cells to be used in this extremely important development effort."
Holubiak added, "No effective pharmacotherapy for ARDS exists, and ARDS-related morbidity and mortality are high. MSCs have been studied in the treatment of lung injury, and we aim to build upon this work with Novellus's iPSC-derived MSCs to improve the immunomodulatory response in humans. We have assembled a team of experts who are dedicated to advancing this project to an Investigational New Drug (IND) application as quickly as possible."
Read The Full Article Here.
After this news dropped yesterday morning, CTXR witnessed a tremendous volume breakout as the stock climbed to a day high of $.84.
Now, that could just be the beginning of potential move up the charts as several other potential catalysts could come into play in the short-term.
CTXR Potential Catalyst - $7.00 Dawson James Price Target
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 say’s “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.
Link To Analyst Report.
A $7.00 Price Target Gives CTXR Serious Potential Upside
A rough calculation from CTXR's Tuesday high per share (approximately $.84 at the time of writing), gives this stock profile a ton of upside potential.
If CTXR is able to find enough momentum to push through its 52-week high of $1.50 in the short-term, this stock could really start making moves.
Another Potential CTXR Catalyst - Positive Clinical Results
Citius Pharmaceuticals Announces Publication in Antimicrobial Agents and Chemotherapy Journal of Positive Preclinical Results for Mino-Lok® in Rapidly Eradicating Candida Auris
March 2020 issue of AAC journal highlights in vitro study at MD Anderson Cancer Center Labs that shows Mino-Lok to be effective in completely eradicating all ten strains of Candida auris tested
CRANFORD, N.J., March 26, 2020 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, announced today the publication of an in vitro study for Mino-Lok®, the Company's antibiotic lock solution used to treat patients with central line associated blood stream infections (CLABSIs) and catheter-related bloodstream infections (CRBSIs), in the March 2020 issue of Antimicrobial Agents and Chemotherapy. The article, titled "Minocycline-EDTA-Ethanol Antimicrobial Catheter Lock Solution Is Highly Effective In Vitro for Eradication of Candida auris Biofilms," highlights the in vitro efficacy of Mino-Lok against various strains of Candida auris ("C. auris") from studies conducted at MD Anderson Cancer Center Labs.
Mr. Myron Holubiak, Chief Executive Officer of Citius, said, "We're happy to have the positive preclinical results of Mino-Lok published in the AAC Journal. Candida auris is a very problematic type of fungus, but the results from these in vitro studies showed that complete eradication of all strains of C. auris occurred within an hour of exposure to Mino-Lok. We anticipate completing our Phase 3 trial with Mino-Lok by the end of 2020, which will bring us one step closer to treating patients with infected catheters from any number of fungi or bacteria."
C. auris is a fungus that can cause serious bloodstream infections or death, particularly in hospital and nursing home patients with serious medical problems. More than one in three patients with invasive C. auris infection die. The fungus is often resistant to most antifungal agents commonly used to treat Candida infections. Although C. auris was just recently discovered in 2009, it has spread quickly and caused infections in more than a dozen countries. Patients who have been hospitalized in a healthcare facility a long time, have a central venous catheter or other lines or tubes entering their body, or have previously received antibiotics or antifungal medications, appear to be at highest risk of infection with this yeast.
Read The Full Article Here.
Final Potential CTXR Catalyst - Low Float Stock Profile
Yahoo Finance reports CTXR to have just over 15Mn shares in its float. With such few shares available for trading, you need to pay attention to volatility.
If momentum floods into this profile, its share price could see some serious spiking in the short-term.
Make sure CTXR is on your screen this second.