CTXR News Update: Released Today, This "Positive FDA Feedback" Could Turn Into A Major Catalyst

Technical Bull Pattern On CTXR Chart Right Now CTXR News Update: Released Today, This "Positive FDA Feedback" Could Turn Into A Major Catalyst CTXR Consensus Target Price Is $5.50/share Representing Over 450% Potential Upside [Go Here To See Analyst Price Target & Report]( June 2nd, 2020 FierceAnalyst Reader, Huge news this AM out of the CTXR camp. Read it here: Citius Receives Positive FDA Feedback on Its Submitted Plan to Study Catheter Compatibility for Mino-Lok® Therapy - Compatibility plan includes testing representative samples of all commercially available CVCs and PICCs - Plan is designed to be conducted in parallel with the completion of the Phase 3 pivotal trial - Targeted worldwide market for Mino-Lok® is expected to reach $1.84Bn by 2028 CRANFORD, N.J., June 2, 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 has received positive feedback from the Food and Drug Administration (FDA) on its proposed catheter compatibility studies for the Company's Mino-Lok® therapy. The studies, if and when successfully completed, should allow Mino-Lok to be labeled for use with all commercially available central venous catheters (CVCs) and peripherally inserted central catheters (PICCs) on the U.S. market. It is further assumed that these studies will meet European and world standards. The ability to be labeled without restrictions with respect to catheter type would allow Mino-Lok unrestricted access to the full U.S. and world markets for an effective antibiotic lock therapy for central line-associated bloodstream infections (CLABSIs), which are estimated to be over $1.5Bn per year worldwide. The catheter compatibility studies will be conducted in parallel with the completion of the ongoing Phase 3 clinical study. The Company announced in early February 2020 that this pivotal trial had reached the halfway point for enrollment. The next milestone in the trial is the result of an interim efficacy analysis, which is expected to occur in the second half of 2020. "We believe we continue to check all the boxes required for an NDA submission," commented Myron Holubiak, Chief Executive Officer of Citius. "According to our planned dosing recommendations, the Mino-Lok solution dwells in the catheter for two hours per day for 5 to 7 days. This would be between 10 to 14 hours of aggregate, but intermittent, exposure time of the catheter to Mino-Lok. We believe that this exposure is far lower than what is recommended for home-brewed antibiotic lock solutions, which should lead to less intrusive therapy and fewer days on therapy for patients." "The shorter dwell time for Mino-Lok also means that the catheter is available for its intended purpose, allowing treatment for the underlying disease to continue. Additionally, and more importantly, 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 home-brewed antibiotic locks in both efficacy and dosing schedules," Mr. Holubiak concluded. [Read The Full Article Here.]( Could this major news help propel this stock through $1.00 resistance? If you haven't, make sure to read my CTXR report and get it on your radar quickly today. ----- Turn your full attention to my favorite biotech stock: Citius Pharmaceuticals, Inc. (ticker symbol: CTXR). The very first time I profiled CTXR was December 19th, 2019 at approximately $.60/share. The stock then sky-rocketed to $1.45/share on January 17th, 2020. That move represented an approximate 145% gain. Then on April 28th I profiled CTXR again. CTXR opened up at approx. $.93/share and hit a high of approximately $1.30/share. That move represented an approximate 39.78% gain... Take a look at the chart below. Notice how the lows are getting higher, and the highs are getting higher as well. Between the very bullish chart, and the huge recent major news acting as potential catalysts, I anticipate multiple eyes on CTXR today! Additionally, the company released shareholder update on May 13th, 2020. Citius Pharmaceuticals Issues May 2020 Shareholder Letter PR Newswire • May 12, 2020 - Company highlights exclusive option to license novel stem-cell therapy for ARDS related to CV-19 from Novellus, Inc. - Status of pivotal Ph. 3 trial evaluating Company's lead-product Mino-Lok® as an antibiotic lock solution used to treat catheter-related bloodstream infections (CRBSIs) is emphasized - Regulatory and clinical updates on Mino-Wrap™ and Halo-Lido also discussed CRANFORD, N.J., May 12, 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 the Company has issued its May 2020 Shareholder Letter. The letter highlights the Company's exclusive option to license a novel stem-cell therapy to treat acute respiratory distress syndrome (ARDS) associated with CV-19, and the clinical progress of the Company's core products: Mino-Lok®, Mino-Wrap™, and Halo-Lido. Recent Company Highlights include: - Submitting a pre-IND to the FDA under the CV Treatment Acceleration Program (CTAP) for a novel stem-cell therapy to treat ARDS associated with CV-19 - Obtaining an exclusive option from Novellus, Inc. to license a stem-cell therapy to treat ARDS associated with CV-19 - Achieving 50% patient enrollment in the Phase 3 Mino-Lok® pivotal trial - Passing the interim futility analysis successfully in the ongoing Phase 3 trial of Mino-Lok vs. standard-of-care antibiotic locks - "Despite the challenges presented by CV-19, we are in the midst of an exciting time for Citius," said Myron Holubiak, Chief Executive Officer of Citius. "We're hard at work on a potentially groundbreaking treatment for ARDS associated with CV-19, and our core therapies are making steady progress through their respective clinical development timelines. I look forward to sharing the future developments with our shareholders as we move forward with our pipeline and achieve clinical and regulatory milestones." ----- CTXR Consensus Target Price Is $5.50/share Representing Over 450% Potential Upside [Go Here To See Analyst Price Target & Report]( -----  Major CTXR News Released On 5/26 Citius Announces Expanded Access Program for Investigational Phase 3 Mino-Lok® -The CV-19 pandemic has highlighted the need to provide Mino-Lok on a compassionate case basis -Many patients in hospitals receive medication, chemotherapy and nutrition via central venous catheters that can become infected and may require a removal and replacement procedure -These catheter replacement procedures are risky for the patients, further tax the healthcare system capacity, and compound the nurse and doctor labor shortage -The company's Mino-Lok® solution could salvage such infected catheters and eliminate the removal and replacement procedure, thus easing the burden on patients, healthcare professionals and systems CRANFORD, N.J., May 26, 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 is providing free access to Mino-Lok® for healthcare providers under an Expanded Access protocol to ease the burden associated with the CV-19 pandemic. Through the Expanded Access protocol, an infected central venous catheter can now be treated with Citius' Mino-Lok, potentially avoiding the need for the removal and replacement procedure. Given the challenges at today's hospitals, the patients, the hospital staff, and the hospital system at large stand to benefit greatly from free access to the Mino-Lok solution. "Some of our investigators have told us that if Mino-Lok were approved by the FDA, they would already be using it – particularly in today's environment," commented Myron Holubiak, Chief Executive Officer of Citius. "We clearly must wait for the results of our clinical trial to fully market Mino-Lok, but we do believe that it can benefit patients and help ease the burden on the health care system. In these challenging times, we welcome the opportunity to help in any way we can." Mino-Lok is an antibiotic lock solution used to treat patients with catheter-related bloodstream infections (CRBSIs) in combination with an appropriate systemic antibiotic(s) to preserve central venous access and to avoid the complications and morbidities associated with catheter removal and reinsertion. Mino-Lok is currently in a Phase 3 clinical trial for the treatment of central line-associated bloodstream infections (CLABSIs). In early February 2020, the Company announced that the trial had reached the halfway point of enrollment. 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 News From April, 2020 Citius Signs Exclusive Option with Novellus to License Novel Stem-Cell Therapy for Acute Respiratory Distress Syndrome (ARDS) Associated with CV-19 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. [Full News Release Found Here For You]( Below Look At Both Analyst Price Targets And Commentary H.C. Wainwright Analyst Raised CTXR Target Price Of $4.00/share H.C. Wainwright analyst Vernon Bernardino raised the price target on Citius Pharmaceuticals (NASDAQ: CTXR) to $4.00/share (from $1.65) while maintaining a Buy rating. [See The Raised Price Target Here]( Vernon Bernardino commented, "In September 2019, the Mino-Lok Phase 3 study Data Monitoring Committee (DMC), which is comprised of a panel of experts on bloodstream infections, conducted its first review of unblinded data after completion of enrollment of the first 40% patients in the study.  One of the initial tasks of the DMC is to conduct a pre-specified interim analysis for futility in the Phase 3 study, or in other words, review study results to determine whether the primary endpoint (i.e., a significant difference between Mino-Lok therapy [MLT] versus conventional antibiotic lock therapy [ALT] in the time to catheter failure) is likely to be achieved.  We believe the recent review of the Mino-Lok Phase 3 study by its DMC, which advised Citius to proceed without any protocol changes and suggested the study remains on track to achieve its primary endpoint, was positive. We also found insights we gained regarding the catheter-related bloodstream infections (CRBSIs) market make us more optimistic regarding Mino-Lok. Therefore we reiterate our Buy rating with a price target of $4.00 versus our prior price target of $1.65. We think Citius shares are underappreciated ahead of a top-line Phase 3 data readout that we expect could be a positive catalyst in mid-2020." 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 develops Mino-Lok, which is in Phase III clinical trials for the treatment and salvage of infected central venous catheters in patients with catheter related bloodstream infections; Mino-Wrap, a liquifying gel-based wrap for reduction tissue expander infections following breast reconstructive surgeries; and Hydro-Lido, a topical formulation of hydrocortisone and lidocaine that is intended for the treatment of hemorrhoids. Citius Pharmaceuticals, Inc. was founded in 2007 and is headquartered in Cranford, New Jersey. Dawson James Securities Price Target Revised 2/25/20 To $7.00/share By Analyst Jason Kolbert Dawson James analyst Jason Kolbert revised the price target on Citius Pharmaceuticals (NASDAQ: CTXR) to $7.00/share maintaining a Buy rating. [See The Raised Price Target Here]( Investment Highlights: Back in October, Citius announced that the first interim analysis point (37 catheter failures, which represents 40% of the anticipated events at ~ 58 patients) had been reached. The DSMB has reviewed the data and, as we expected, advised that the trial continues, unchanged. We view the DSMB’s update as positive. It tells us that the trial has been properly powered. The DSMB could have recommended increasing the trial (add statistical power to see the signal with a p-value). 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. Citius Pharmaceuticals, Inc. --> [Shareholder Letter For Corporate Update]( <- Insider Buying On Citius Pharmaceuticals, Inc. (CTXR) Over the last year, we can see that the biggest insider purchase was by Executive Chairman & Secretary Leonard Mazur for approximately US$4.0m worth of shares, at about US$1.28 per share. That is double the price of the stock today. Over the last year, we can see that insiders have bought 6.5m shares worth US$7.0m. While Citius Pharmaceuticals insiders bought shares last year, they didn't sell. The average buy price was around US$1.08. Citius Pharmaceuticals insiders own 46% of the company. $7Mln. Capital Raise With H.C. Wainwright On September 27, 2019, CTXR closed a $7 million capital raise with H.C. Wainwright (“HCW”) to position our Company better for growth and advance our ongoing research. We have worked with HCW in the past, and, to date, management has invested nearly $27 million in the Company. This significant investment, when compared to many other biotech microcap companies, is a testimony to the commitment we have made to the success of the company and the unwavering belief we share in the potential and value of the assets we are developing.  CTXR Consensus Target Price Is $5.50/share Representing Over 450% Potential Upside [Go Here To See Analyst Price Target & Report]( Coverage initiated once again on Citius Pharmaceuticals Inc. (CTXR) effective immediately. Sincerely, Fierce Analyst | Jaks Swift Editorial Writer I am not a licensed financial adviser. All potential percentage gains are based on from the low to the high of day. Fierce full disclosure is to be read and fully understood before using Fierce's website, or joining Fierce's email or text list. By viewing Fierce's website and/or reading Fierce's email or text newsletter you are agreeing to -> [( Stock Wire News (stock wire news . com) is owned by Stock News Wire LLC, a limited liability company. 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