StockWireNews
New NASDAQ Profile (CTXR) Displays Breakout Potential After A Major News Release
Two Analysts' Deliver $7 And $4 Targets, Providing Weighted Average Of $5.50 And Approx. 500%+ Upside Potential
DJS Analyst Report
April 28th
Good Morning,
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.
#1 CTXR Potential Catalyst - Yesterday's Major News Release
Citius Announces Pre-IND Submission to FDA Under the CV Treatment Acceleration Program for a Novel Stem Cell Therapy for Acute Respiratory Distress Syndrome (ARDS) in CV-19
- Company's goal to initiate clinical trial in patients in 2020
- Innovative therapy candidate uses next generation mesenchymal stem cells (MSCs) derived from a master cell bank of induced pluripotent stem cells (iPSCs)
CRANFORD, N.J., April 27, 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 that it submitted a pre-IND meeting request and supporting briefing documents to the Center for Biologics Evaluation and Research ("CBER") of the FDA under the CV Treatment Acceleration Program (CTAP) on April 24. The Company has requested the Division's feedback to support the most expeditious pathway into the clinic to evaluate a novel cell therapy in patients suffering from CV-19-related ARDS.
The cells, called NoveCite Cells or NC-MSCs, are made by Novellus, Inc. ("Novellus"), a Cambridge-based biotechnology company, using its patented mRNA-based cell-reprogramming process. NC-MSCs are mesenchymal stem cells derived from a single donor's fibroblasts that have been dedifferentiated into an induced pluripotent stem cell (iPSC) master cell bank, thereby avoiding the need to source additional donor cells. The iPSCs are then further differentiated into a mesenchymal stem cell (MSC) therapy. Citius and Novellus plan to develop NC-MSCs for the treatment of ARDS, and last month the companies signed an exclusive option agreement.
The Company plans a multi-center randomized placebo-controlled dose-finding study followed by an expansion phase to assess the safety, tolerability, and efficacy of NC-MSCs in patients with moderate to severe ARDS due to CV-19. The proposed trial, a Phase 1b/2 clinical trial, is titled "A Randomized Placebo-Controlled Dose-Finding Study Followed by a Dose Level Expansion to Assess the Safety and Efficacy of NoveCite MSCs in Subjects with Acute Respiratory Distress Syndrome (ARDS) Due to [...] Disease (CV-19)," or "MARCO". The primary objectives of this study are to evaluate the safety and efficacy of NoveCite cells as a treatment for subjects with moderate-to-severe ARDS due to CV-19 and to identify therapeutic doses.
"MSCs have an established track-record of clinical safety, and have shown promise in the treatment of inflammatory lung disease," said Matt Angel, PhD, co-founder and Chief Science Officer at Novellus, Inc. "Our research has shown that the NoveCite cells, being derived from mRNA-reprogrammed iPSCs, secrete higher levels of immunomodulatory proteins than donor-derived MSCs, and have unique manufacturing advantages."
"We believe we have the key elements in place from a clinical design and manufacturing point of view to evaluate this novel cell therapy approach to deal with the current pandemic," said Myron Holubiak, Chief Executive Officer of Citius. "ARDS is a very serious complication for many patients suffering from CV-19, and is believed to account for about 80% of the deaths in ventilated patients. There is no proven or FDA-approved treatment for it, other than oxygen therapy, including use of mechanical ventilation, and fluid management. Literature from previous investigational studies with MSCs in the treatment of lung injuries support the idea that MSCs could prove effective in treating CV-19-related ARDS. We look forward to our FDA discussions and are excited to be at the cusp of what could be a novel and effective therapy for ARDS."
Read The Full Article Here.
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#2 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.
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#3 CTXR Potential Catalyst - $4 Target From H.C. Wainwright
Back On January 24th, H.C. Wainwright analyst Vernon Bernardino raised the price target on Citius Pharmaceuticals to $4.00 (from $1.65) while maintaining a Buy rating.
When you combined both the H.C. Wainwright target with the Dawson James Securities target, and you get a weighted average target of $5.50.
From CTXR's current trading levels, that gives the stock over 450% potential upside.
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#4 CTXR Potential Catalyst - Low Float Stock Profile
Yahoo Finance reports CTXR to have just over 17Mn 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.
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