Biotech Breakout Citius Pharmaceuticals’ (NSDQ: CTXR) Phase 3 Results Could Transform the $3.5 Billion Fight Against this Deadly Affliction … and that’s Just the Beginning …
Get the latest stock ideas direct to your inbox. 100% free and your information stays with us.
Citius Pharmaceuticals United States NASDAQ: (CTXR) is cutting-edge and stands at the forefront of revolutionary breakthroughs within the 3.5 billion dollar fight for life in the cancer crusade. CTXR focuses on late stage biopharmaceutical development and application of critical care products aligned in oncology, adjunct cancer care, stem cell therapy, and unique prescription products.
With five different Candidates that CTXR has in their pipeline, CTXR is driven by these three principles in their mission to deliver top of the line therapies for patients with critical unmet needs in adjunct cancer care, gastrointestinal disease, and infectious disease:
Non-Hodgkin’s Lymphoma is one of the deadliest forms of cancer.
Targeting your body’s germ-fighting immune system, it invades your body’s lymph nodes. Left unchecked, it can kill more than 1-in-3 of those diagnosed, with over a half-million new cases each year.
But one company could be set to change all that …
Flying well under the radar, Citius Pharmaceuticals (NSDQ: CTXR) has quietly acquired the rights to the experimental compound “E-7777,” a direct improvement to a previously FDA-approved medication that directly attacks infected cancer cells inside the human body.
And this new cancer-fighting remedy could be mere months away from its own approval.
If and when it hits the market, this new treatment could provide a whole new proven alternative to the harsh side effects of chemotherapy or aggressive radiation treatment.
Directly targeting and attacking infected cells, E-7777 could transform the $3.5 Billion market for Non-Hodgkin’s Lymphoma treatment. The anticipated PDUFA action date is July 28, 2023.
The best part of this whole story? This is just one of several potentially game-changing new therapies in the company’s pipeline …
Bullish Divergence on the 4 hour chart
Strong support above 1.00/share
Recent break over the 200 SMA on the 4 hour chart
Golden Cross MACD on daily chart just last week
Similar setup to our recent explosive stock breakouts of $CLMD, $ATNX, $APCX, and $COSM, as the market is shifting into biotech stocks expected to outperform the market in quarter one and two of 2023!
With a break and hold of $1.08 we have broken through a major point of confluence, paired with breaking the 200SMA on the daily. A break and hold above 1.20 early this week, and a hold above that 200SMA and the next leg up should test the 1.35 to 1.40 area within a couple days.
If we hold and the 200SMA becomes a support zone, the next leg up should be a strong and impulsive move that usually gives some strong gains.
Mino-Lok is an antibiotic designed to treat patients with catheter-related bloodstream infections (CRBSIs). At present, these infections are treated by removing the catheter and prescribing antibiotics.
This is a costly medical process with potential complications. In fact, studies show that removal and reinsertion of CVCs have a 15% to 20% complication rate, including pneumothorax, misplacement, and arterial puncture.
Mino-Lok allows doctors to treat the infection without needing to remove the catheter, avoiding both costs and complications. It’s a simple, prescription solution to another $3.5 Billion problem.
Currently, in Phase 3 pivotal trials, it could be approved in a matter of months …
According to CEO Myron Holubiak:
“Data from the Mino-Lok® (M-L) Phase 3 program was reviewed by our independent Data Monitoring Committee (DMC) for safety and efficacy and found to be progressing as planned with no recommended changes to trial design.”
Mino-Lok has reportedly performed well to date
Citius’ Mino-Wrap could help reduce post-operative infections associated with surgical implants. Its gel-containing film is used primarily to wrap the tissue expander used in breast reconstructive surgeries.
As also noted by CEO Holubiak:
“We believe that this serious condition impacts about 100,000 women in the U.S. and many more in the rest of the world. Mino-Wrap is a bio-absorbable, antimicrobial semi-solid film that is wrapped around a tissue expander and placed in the surgical pocket following a mastectomy to prevent post-surgical infections. Once implanted, Mino-Wrap slowly dissolves in situ for a specified period of time, providing extended protection against infection.”
Shockingly, there are no FDA-approved prescription products for hemorrhoids at the moment.
However, that could soon change with Citius’ halobetasol and lidocaine formulations.
Hemorrhoids are an uncomfortable and often recurring condition. However, despite the numerous prescription and over-the-counter (OTC) products commonly used to treat hemorrhoids, none possess the necessary safety and efficacy data generated from rigorously conducted clinical trials.
Citius believes its halobetasol-lidocaine product could one day become that go-to treatment for physicians wanting to provide patients with a therapy demonstrating safety and efficacy.
• There are about three million cases of Acute Respiratory Distress Syndrome (ARDS) globally, with approximately 200,000 instances just in the U.S.
• The health crisis significantly added to the amount of ARDS cases, with death rates among patients on ventilators as high as 50%.
• Worse, at the moment, there are no approved treatments for ARDS.
According to Citius CEO Holubiak:
“Currently, there is no FDA-approved drug therapy for ARDS. We plan to submit an IND to the FDA and initiate our Phase 1 study by the end of the second quarter of 2022. Our first-in-human clinical trial is entitled “i-MSCs in Subjects with Acute Respiratory Distress Syndrome (ARDS) Due to [the health predicament]: i-MARCO.” Following the completion of a multi-center Phase 1 pilot study, we would expect to proceed on to a double-blinded, randomized Phase 2/3 trial to demonstrate the safety, efficacy, and multimodal healing capabilities of our i-MSCs in patients with moderate to severe ARDS due to [the health predicament].”
• Novel stem cell therapy for the treatment of acute inflammatory respiratory disorders including acute respiratory distress syndrome (ARDS)
• i-MSCs derived from induced pluripotent stem cell reprogrammed using proprietary mRNA process
• No FDA-approved treatment for ARDS exists today
• Preclinical activities are underway
As you’ve seen today, some of the treatments in Citius Pharmaceuticals’ portfolio go far beyond the definition of “Cutting Edge” …
Mino-Lock could potentially erase the need to operate on those suffering from Catheter-Related Bloodstream Infections (CRBIs), revolutionizing treatment of a $1.5 Billion medical problem overnight. E-7777 could offer a powerful new alternative to those suffering from Non-Hodgkin’s Lymphoma.
Combined with a full pipeline of other treatments, Citius Pharmaceuticals could be sitting on top of $5.5 Billion in cumulative pharmaceutical market disruption…
With over 5 years of “cash runway” left to complete critical Research & Development, along with the outrageous profit potential if even one of these treatments makes it to market, Citius Pharmaceuticals (NSDQ:CTXR) is a company that should definitely be on your radar.
Source 1: https://www.prnewswire.com/news-releases/citius-receives-positive-fda-feedback-on-its-submitted-plan-to-study-catheter-compatibility-for-mino-lok-therapy-301069349.html
Source 2: https://www.prnewswire.com/news-releases/citius-pharmaceuticals-to-highlight-its-phase-3-clinical-trial-product-mino-lok-at-benzinga-biotech-small-cap-conference-on-march-25-301253709.html
Source 3: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4093967/
Source 4: https://www.citiuspharma.com/opportunity/crbsis/
Source 5: https://www.everydayhealth.com/things-your-doctor-wont-tell-about-hospital-infections/
Source 6: https://www.gurufocus.com/news/697235/citius-announces-united-states-patent-trademark-office-registered-the-companys-minolok-trademark
Source 7: https://www.citiuspharma.com/mino-lok/
Source 8: https://www.citiuspharma.com/wp-content/uploads/2021/02/CTXR_Shareholder_Letter_Feb2021.pdf
Source 9: https://www.citiuspharma.com/mino-wrap/
Source 10: https://stockcharts.com/h-sc/ui?s=ctxr
Source 11: https://www.barchart.com/stocks/quotes/CTXR/opinion
Source 12: https://www.citiuspharma.com
Source 13: https://d1io3yog0oux5.cloudfront.net/_335875ea4142d81b5406df99d97e4cdf/citiuspharma/db/249/1064/pdf/3.19.2021.WEB.Presentation_Final.pdf
Source 14: https://www.citiuspharma.com/wp-content/uploads/2021/02/CTXR_Shareholder_Letter_Feb2021.pdf
Source 15: https://www.citiuspharma.com/mino-wrap/
Source 16: https://www.citiuspharma.com/halo-lido/
Source 17: https://ir.citiuspharma.com/press-releases/detail/122/citius-pharmaceuticals-signs-an-exclusive-worldwide
Source 18: https://citiuspharma.com/pipeline/mino-lok/default.aspx
Source 19: https://citiuspharma.com/pipeline/mino-wrap/default.aspx
Source 20: https://www.citiuspharma.com/halo-lido/#:~:text=There%20are%20no%20FDA%2Dapproved,hemorrhoids%20in%20the%20United%20States
Source 21: https://citiuspharma.com/pipeline/stem-cell-platform/default.aspx
Source 22: https://www.cancer.net/cancer-types/lymphoma-non-hodgkin/statistics#:~:text=The%20overall%205%2Dyear%20survival,survival%20rate%20is%20around%2063%25.
Source 23: https://pubmed.ncbi.nlm.nih.gov/30895415/
Source 24: https://www.nuventra.com/resources/blog/why-do-clinical-trials-fail/#:~:text=This%20means%20that%20around%202,3%20fail%20to%20reach%20approval.
Source 25: https://www.google.com/search?rlz=1C1CHBF_enUS977US977&q=NASDAQ:+CTXR&stick=H4sIAAAAAAAAAONgecRowS3w8sc9YSn9SWtOXmPU5OIKzsgvd80rySypFJLmYoOyBKX4uXj10_UNDZOSzSxLDLIzeBax8vg5Brs4BlopOIdEBAEAzts1gUwAAAA&sa=X&ved=2ahUKEwi9i77gz8r0AhV1SzABHY-TBrkQsRV6BAg0EAM&biw=1536&bih=792&dpr=1.25
Source 26: https://simplywall.st/stocks/us/pharmaceuticals-biotech/nasdaq-ctxr/citius-pharmaceuticals/news/we-think-citius-pharmaceuticals-nasdaqctxr-can-afford-to-dri-1
Stock Research Today is a project of Dadmin Capital LLC and intended solely for entertainment and informational purposes. Consult your financial, investment and tax advisors to determine what financial and tax strategies may be right for you. Investor protection and other important information is available at https://www.sec.gov/. This website / media webpage is owned, operated and edited by Dadmin Capital LLC. Any wording found on this website / media webpage or disclaimer referencing “I” or “we” or “our” or “Dadmin Capital” refers to Dadmin Capital LLC. This website / media webpage is a paid advertisement, not a recommendation nor an offer to buy or sell securities. Our business model is to be financially compensated to market and promote small public companies. By reading our website / media webpage you agree to the terms of our disclaimer, which are subject to change at any time. We are not registered or licensed in any jurisdiction whatsoever to provide investing advice or anything of an advisory or consultancy nature and therefore are unqualified to give investment recommendations. Always do your own research and consult with a licensed investment professional before investing. This communication is never to be used as the basis for making investment decisions and is for entertainment purposes only. At most, this communication should serve only as a starting point to do your own research and consult with a licensed professional regarding the companies profiled and discussed. Conduct your own research. Companies with low price per share are speculative and carry a high degree of risk, so only invest what you can afford to lose. By using our service you agree not to hold our site, its editor’s, owners, or staff liable for any damages, financial or otherwise, that may occur due to any action you may take based on the information contained within our website / media webpage .We do not advise any reader take any specific action. Losses can be larger than expected if the company experiences any problems with liquidity or wide spreads. Our website / media webpage are for entertainment purposes only. Never invest purely based on our alerts. Gains mentioned in our website / media webpage may be based on end-of-day or intraday data. This publication and their owners and affiliates may hold positions in the securities mentioned in our alerts, which we may sell at any time without notice to our subscribers, which may have a negative impact on share prices. If we own any shares we will list the information relevant to the stock and number of shares here. Dadmin Capital business model is to receive financial compensation to promote public companies. To conduct investor relations advertising, marketing and publicly disseminate information not limited to our websites, email, sms, push notifications, influencers, social media postings, ticker tags, press releases, online interviews, podcasts, videos, audio ads, banner ads, native ads, responsive ads. This compensation is a major conflict of interest in our ability to be unbiased regarding. Therefore, this communication should be viewed as a commercial advertisement only. We have not investigated the background of the hiring third party or parties. The third party, profiled company, or their affiliates likely wish to liquidate shares of the profiled company at or near the time you receive this communication, which has the potential to hurt share prices. Any non-compensated alerts are purely for the purpose of expanding our database for the benefit of our future financially compensated investor relations efforts. Frequently companies profiled in our alerts may experience a large increase in volume and share price during the course of investor relations marketing, which may end as soon as the investor relations marketing ceases. Our emails may contain forward-looking statements, which are not guaranteed to materialize due to a variety of factors. We do not guarantee the timeliness, accuracy, or completeness of the information on our website / media webpage. The information in our website / media webpage is believed to be accurate and correct, but has not been independently verified and is not guaranteed to be correct. The information is collected from public sources, such as the profiled company’s website and press releases, but is not researched or verified in any way whatsoever to ensure the publicly available information is correct. Furthermore, Dadmin Capital. often employs independent contractor writers who may make errors when researching information and preparing these communications regarding profiled companies. Independent writers’ works are double-checked and verified before publication, but it is certainly possible for errors or omissions to take place during editing of independent contractor writer’s communications regarding the profiled company(s). You should assume all information in all of our communications is incorrect until you personally verify the information, and again are encouraged to never invest based on the information contained in our written communications. The information in our disclaimers is subject to change at any time without notice. Compensation – Pursuant to an agreement between Dadmin Capital LLC and TD Media LLC, Dadmin Capital LLC has been hired for a period beginning on 12/08/21 and ending after 3 business days to publicly disseminate information about (NASDAQ: CTXR) via digital communications. We have been paid seven thousand five hundred USD via ACH Bank Transfer. Pursuant to an agreement between Dadmin Capital LLC and TD Media LLC, Dadmin Capital LLC has been hired for a period beginning on 5/4/22 and ending after 2 business days to publicly disseminate information about (NASDAQ: CTXR) via digital communications. We have been paid eleven thousand five hundred USD via ACH Bank Transfer.