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New NASDAQ Profile (CTXR) Has Major Breaking News This AM
"Positive Outcome" In Phase 3 Trial - Read The PR Below
Dawson James Securities Analyst Report
December 19th
Good morning,
Here's your surprise stock profile for today's trading session:
Citius Pharmaceuticals, Inc. (CTXR)
Citius Pharmaceuticals is a specialty pharmaceutical company dedicated to the development and commercialization of critical care products, with a focus on anti-infectives, cancer care, and unique prescription products that use innovative, patented, or proprietary formulations of previously-approved active pharmaceutical ingredients.
Now, this is why you need to pay attention to this stock profile closely...
#1 Key Catalyst For CTXR - Today's Positive Outcome News
Dropping this AM, CTXR could see serious interest as this news may turn major catalyst:
Citius Announces Positive Outcome of Interim Futility Analysis for its Phase 3 Mino-Lok® Pivotal Trial
- Data Monitoring Committee recommends continuation of the trial with no changes
CRANFORD, N.J., Dec. 19, 2019 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (NASDAQ: CTXR), a specialty pharmaceutical company focused on adjunctive cancer care and critical care drug products, today announced a positive outcome of the pre-specified interim futility analysis for the Phase 3 clinical trial of Mino-Lok® vs. standard-of-care antibiotic locks. The analysis was conducted by the Mino-Lok trial Data Monitoring Committee ("DMC"), an independent panel of experts charged with periodically monitoring the safety and efficacy of the progress of the pivotal trial. The Company reached and completed the prespecified 40% enrollment required for the interim futility analysis in late September and, based on the analysis of the data and recommendations of the DMC, will proceed with the current trial as planned. Topline data from the superior efficacy interim analysis, the next major milestone in the Mino-Lok trial, is expected in the first half of 2020. 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.
"We are extremely happy and proud that the first independent expert review of the patient data in our Mino-Lok trial concludes that our study is on track. Enrollment has continued since finalizing the 40% level futility report, and we have now reached the midpoint of our study. The DMC will evaluate clinical data at the 75% level of enrollment to see if Mino-Lok demonstrates superior efficacy versus standard-of-care antibiotic locks," said Myron Holubiak, the Chief Executive Officer of Citius. "We would also like to thank all of the patients, study investigators, and support personnel at the 32 clinical sites that are participating in our trial. Lastly, we also want to acknowledge the research and guidance of Dr. Issam Raad and his team at MD Anderson Cancer Center in advancing this novel therapy."
#2 Key Catalyst For CTXR - $7.00 Analyst Price Target
Here are some of the highlights from the Dawson James Securities updated October 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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A $7.00 price target gives CTXR Serious Potential Upside
A rough calculation of CTXR's current price per share ($.60 at the time of writing), gives this stock profile a ton of upside potential.
Even if CTXR only climbs back to its 52-Week high of $1.79, it would still provide traders with significant potential upside from current levels.
#3 Key Catalyst For CTXR - November's Corporate Update
Released last month, the company sent out an update to all of its shareholders with recent developments pointing towards positive outcomes moving forward for CTXR.
Here are some of the highlights:
- Closing on a recent $7Mn capital raise to advance ongoing research
- A recent modification to the primary endpoint of the pivotal Phase III trial for Mino-Lok that substantially reduced the required trial sample size from 700 to approximately 144 subjects, significantly reducing the trial's expense and accelerating its completion
- An expanded relationship with MD Anderson Cancer Center for a worldwide license for Mino-Wrap and the preparation for a pre-IND meeting with the FDA
- Reformulating the topical formulation (now Halo-Lido) for the treatment of hemorrhoids based on results from an initial Phase II study. A toxicology study will be initiated by year-end ahead of an expanded Phase II study to start in 2020
- Other corporate initiatives that include industry events and more
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#4 Key Catalyst For CTXR - Bullish 6-Month Chart & Technicals
CTXR has been building momentum in the short-term which is represented in its 6-Month chart. See below:
