What Could Potential FDA Approval Mean for This Little-Known Biotech Stock in Early 2024?

Dawson James Analyst Jason Kolberts’ $10.00 target could mean potential upside of 1,198% for Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) right after bouncing off its 52-week low of $.77 cents on 12/30/22 according to Barchart.com’s price history.

Price Targets





Potential support zone: 0.6020

7 Reasons why Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) could witness unstoppable growth in 2024.

Analyst Target: Dawson James Analyst Jason Kolberts’ $10.00 target could mean potential upside of 1,198% for Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) right after bouncing off its 52-week low of $.77 cents on 12/30/22 according to Barchart.com’s price history.

Active Chart: Since bottoming out and hitting its 52-week low of $.77 cents on 12/30/22, shares of Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) have climbed to $1.13 for a solid 46.75% move in less than 10 days.

FDA Confirmation: Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) has reported that the FDA confirmed Prescription Drug User Fee Act (PDUFA) target action date of July 28, 2023.

Phase 3 Trial: Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) completed Pivotal Phase 3 trial of I/ONTAK (E7777) and submitted biologics license application (BLA) to the U.S. Food and Drug Administration (FDA).

Biotech Cluster With 70 New FDA Approvals: The company is headquartered in a hotbed and breeding ground for successful Biotechs, which were responsible for a staggering 70 new FDA dr-ug approvals between 2020 and 2021.

Accelerated Advancement: Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) expanded and accelerated its Phase 3 Mino-Lok trial to additional sites outside the United States. If approved, Mino-Lok would be the first-and-only antibiotic lock solution FDA-approved to salvage infected central venous catheters (CVCs) causing catheter-related bloodstream infections (CRBSIs).

Clinical Collaboration: Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) initiated a clinical collaboration with the University of Pittsburgh to evaluate regulatory T-cell (T-reg) depletion with I/ONTAK (E7777) in combination with pembrolizumab in recurrent or metastatic solid cancer tumors in a Phase 1 investigator-initiated trial, with first patient enrolled in November 2022.

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR)

Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) Gets $10.00 Target From Dawson James Analyst Jason Kolberts.

Jason Kolberts is no stranger to the biotech and pharmaceutical industries.

He’s actually the Director of Research at Dawson James Securities, Inc.

And for those who don’t know, Dawson James is a full-service boutique investment banking firm focused on emerging growth companies since 2004 and committed to helping clients navigate the healthcare, biotechnology and technology markets.

Jason Kolberts’ career began as a chemist in the pharmaceutical industry and evolved into a product and marketing manager with Schering-Plough in Japan. Upon returning from Japan, Jason joined Salomon Smith Barney, as a research associate which has now evolved into a 20-year career on Wall Street as a leader in the Healthcare space.

Kolberts’ coverage expands across multiple therapeutic areas in biotechnology, specialty pharmaceuticals, and medical devices. As an analyst Jason has developed a high level of expertise in oncology, virology and cell-based medicine such as CAR (Chimeric Antigen Receptor)-T cells and regenerative medicine (stem cells).

Prior to joining Dawson James, Mr. Kolbert spent the prior year as a senior biotechnology analyst at HC Wainwright and spent the previous seven years at the Maxim group, where he was an Executive Managing Director and the Head of Healthcare Research at the firm. During this period Jason and his team covered 80 names across the healthcare vertical. Jason’s Wall Street career began with seven years at Citi Group followed by several years on the buy side as a portfolio manager with the Susquehanna International Group.

One company that seems to have caught the eye of Jason Kolbert is Citius Pharmaceuticals, Inc. (Nasdaq: CTXR).

Mr. Kolbert has a $10.00 target on Citius Pharmaceuticals, Inc. (Nasdaq: CTXR).

This could mean a potential upside of 1,198% for Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) after a recent bounce off its 52-week low of $.77 cents on 12/30/22 according to Barchart.com’s price history.

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 …


$CTXR is sitting at a technical breakout point on the lower timeframe, and held support on the higher timeframes.

This could potentially result in a triple-digit reversal with volume and sustained trend bias.

If support holds here at $0.602, we can see potential upside to test $0.80 > $1.00+.

RSI holding strong at 40, needs to hold for reversal to the upside.

Here’s How Mino-Lok Could Help With Another $1.5 Billion Medical Crisis:

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

  • Mino-Lok is the first and only therapy under investigation to salvage infected CVCs.
  • In a Phase 2b trial, the Mino-Lok product demonstrated a 100% efficacy rate in salvaging colonized CVCs.
  • Mino-Lok had no significant adverse events compared to an 18% serious adverse event rate when infected CVCs were removed and replaced.
  • FDA Fast Track with QIDP designation and patent protection until June 2024. Formulation patent protection until November 2036.
  • Currently in a Phase 3 pivotal superiority trial.

Meanwhile, Citius’ “Mino-Wrap” Could Revolutionize $400 Million Post-Mastectomy Infection Prevention Market

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.”

Program Highlights

  • Potential to be first and only FDA-approved product to prevent infections associated with post-mastectomy breast implants
  • Currently in pre-clinical development
  • Development in partnership with The University of Texas MD Anderson Cancer Center and support from medical thought leaders

Offering Relief in an $80 Million Hemorrhoids Market

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.

Program Highlights

  • There are no FDA-approved prescription products on the market for hemorrhoids
  • Citius’ halobetasol and lidocaine formulation could become the first FDA-approved prescription product to treat hemorrhoids in the United States
  • According to IMS, over 25 million units of topical combination prescription products for are sold in the US

Citius Pharmaceuticals (NSDQ: CTXR) Could Even Help Treat ARDS, Too

• 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].”

Program Highlights

• 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

$5.5 Billion in Potential Market Disruption (From a $220 Million Company)

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.



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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.pdfEditSign

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

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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

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Source 52: https://finance.yahoo.com/news/citius-pharmaceuticals-inc-reports-fiscal-200500315.html


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