CTXR keeps chugging right along today.

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In A Sea Of Red, Nasdaq Past Champ (CTXR) Just Hit A New 2023 High (Watching Yet?)

January 19th

Greetings Readers,

CTXR keeps chugging right along today.

With the overall markets taking a punch in the gut today, CTXR has little signs of slowing down.

Hitting a new $1.38 high of day, it has also achieved its highest valuation of 2023.

Could this be a sign of things to come?

Remember, it is trading above its 50-Day Simple Moving Average (SMA), its 200-Day SMA, and its 13-Day Exponential Moving Average.

Make sure CTXR is high on your watch-list the remainder of this week.

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Strap in. This could get wild. But first, a quick recap:

My first profile this week has now made a two day max move of approximately 59% from an open of $5.25 to Tuesday's $8.35 high.

That was followed with Wednesday's profile that surged approximately 27% intraday from its open to its high of day.

Now, I want to reintroduce another Nasdaq past champ to your immediate focus.

On April 19th, 2021, I brought this profile to your attention only to watch it run from an open that day of $1.99 to a high of $4.56 by June 22nd.

Overall, that approximate $2.00+ surge resulted in this breakout idea running approximately 129%.

And guess what? It's time to get it back on radar. Here's why...

Based on a significant analyst target providing over 650% potential upside, currently trading above 3 key lines of potential support, and the potential for FDA approval on the horizon, this past champ could be set for a breakthrough year in 2023.

For Thursday, January 19th, there is only one Nasdaq biopharma idea to have on your watch-list:

*Citius Pharmaceuticals, Inc. (CTXR)*

Citius is a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products, with a focus on oncology, anti-infectives in adjunct cancer care, unique prescription products, and stem cell therapies.

And right now, this profile has 4 potential catalysts to be fully aware of. They include:

No. 1 - A $10 Analyst Target Paints The Possibility For An Exceptionally Bright Future

No. 2 - Corporate Update Provides Glimpse Of How Big 2023 Could Be For CTXR

No. 3 - FDA Accepts Company's BLA For E7777, Target Action Date For PDUFA In September

No. 4 - Trading Above Key Support Lines Could Mean Big Things Ahead Near Term

But more on those in a second...

Citius Pharmaceuticals, Inc. (CTXR) Could Be A BioPharma Powerhouse Hiding In Plain Sight

Citius Pharmaceuticals is what’s called a “late-stage biopharmaceutical" company, where a highly-experienced management team purchases rights to the most promising new therapies and then either brings them to market or licenses rights to bigger pharma companies like Pfizer or Johnson & Johnson.

It should go without saying that “late-stage” development is the most difficult, most expensive part of the process for any new kind of treatment. Because even after years of in-vest-ment, research and development, some 2 out of 5 drugs still fail to secure final FDA approval.

But with a “Dream Team” of top industry insiders, Citius is turning the odds in their favor—with two treatments now in Phase 3.

Citius Pharmaceuticals 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 potential $12.57Bn future market for Non-Hodgkin’s Lymphoma treatment.

The best part of this whole story? This is just one of several potentially game-changing new therapies in the company’s pipeline…

image

(Source)

In addition to E-7777, it’s currently advancing three proprietary product candidates in total:

  • CITI-002 (Halo-Lido), a topical formulation of halobetasol, a corticosteroid, and lidocaine to provide anti-inflammatory and anesthetic symptomatic relief to hemorrhoids victims. It is currently gearing up for a Phase IIb trial.
  • CITI-101 (Mino-Wrap), a liquefying gel-based wrap containing minocycline and rifampin designed to provide inflammatory tissue protection and prevent infection and biofilm formation in tissue expanders and breast implants post-mastectomy. In December 2020, Citius received a written response and guidance from the USFDA for Mino-Wrap development. Citius expects to file for an IND by the end of this year.
  • Mino-Lok, an antibiotic lock solution developed as adjunctive therapy for patients with central line-associated bloodstream infections (CLABSIs) or catheter-related bloodstream infections (CRBSIs). If approved, Citius believes that Mino-Lok could enter a $1.5Bn worth market and prove to be a blockbuster without any immediate competition.

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And right now, CTXR has 4 potential catalysts to soak in this second. Following along...

No. 1 CTXR Potential Catalyst - A $10 Analyst Target Paints The Possibility For An Exceptionally Bright Future

Back in December, Jason Kolbert, an analyst with Dawson James Securities, tagged CTXR with a $10.00 target.

That provides CTXR with a mind-blowing potential upside over 650% from Wednesday's close.

Here's some key highlights from the report:

Mino-Lok is approaching the finish line: Management stated in the press release: “we expected to achieve 92 catheter failure events with 144 patients by the end of 2022”, and “We have now exceeded our targeted enrollment and have achieved 72 of the required catheter failure events”, “we anticipate that the 92-event threshold required to complete the trial is achievable in the coming months." We view this as positive and representing the key catalyst for the stock to appreciate.

ONTAK Too. We also take note that management highlighted a July PDUFA date for ONTAK. We believe this sets the stage for the company to spin-out and then raise capital for NEWCO to support the drug's commercialization. This should translate into the company unlocking the value around the product's original acquisition (Citius paid $40M upfront and has an obligation for $40M in milestones, and we assume a 10% royalty).

Valuation. Our valuation is based on our therapeutic models and associated assumptions projected to 2028. The lead product, Mini-Lok, is now in a Phase 3 trial, as is E7777. We 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 on top of a 15% risk rate in our therapeutic models for both products. We equal weight and average these metrics and then round to the nearest whole number to derive our $10.00 price target.

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No. 2 CTXR Potential Catalyst - Corporate Update Provides Glimpse Of How Big 2023 Could Be For CTXR

Citius Pharmaceuticals, Inc. Reports Fiscal Full Year 2022 Fi-nan-cial Results and Provides Business Update

$41.7Mn in cash and cash equivalents as of September 30, 2022; extends runway through December 2023

Mino-Lok® Phase 3 trial closer to completion with 169 patients recruited, 72 failure events and 17 patients in active treatment or pending data review

I/ONTAK BLA accepted for filing by the FDA; updated PDUFA target action date is July 28, 2023

Halo-Lido Phase 2b trial progressed; data readout expected 2H 2023

Multiple value-driving catalysts anticipated in 2023, including a potential drug approval and two trial completions

CRANFORD, N.J., Dec. 22, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company dedicated to the development and commercialization of first-in-class critical care products today reported business and fi-nan-cial results for the fiscal full year ended September 30, 2022.

Fiscal Full Year 2022 Business Highlights and Subsequent Developments

  • Completed Pivotal Phase 3 trial of I/ONTAK (E7777) and submitted biologics license application (BLA) to the U.S. Food and Drug Administration (FDA);
  • FDA confirmed Prescription Drug User Fee Act (PDUFA) target action date of July 28, 2023;
  • Advanced Mino-Lok® Phase 3 trial;
  • Initiated Phase 2b trial of Halo-Lido for the treatment of hemorrhoids in April 2022; patient enrollment ongoing with data readout expected 2H 2023;
  • Initiated 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; and,
  • Approved for $3.6Mn in non-dilutive capital through the New Jersey Economic Development Program to support ongoing research and development efforts.

...

Read the full article here.

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No. 3 CTXR Potential Catalyst - FDA Accepts Company's BLA For E7777, Target Action Date For PDUFA In September

Citius Pharmaceuticals, Inc. Announces U.S. Food and Drug Administration Acceptance of Biologics License Application of Denileukin Diftitox for the Treatment of Patients with Persistent or Recurrent Cutaneous T-Cell Lymphoma

Prescription Drug User Fee Act (PDUFA) target action date is September 28, 2023

CRANFORD, N.J., Dec. 1, 2022 /PRNewswire/ -- Citius Pharmaceuticals, Inc. ("Citius" or the "Company") (Nasdaq: CTXR), a late-stage biopharmaceutical company developing and commercializing first-in-class critical care products, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company's Biologics License Application (BLA) for denileukin diftitox ("I/ONTAK" or "E7777"), an engineered IL-2-diphtheria toxin fusion protein for the treatment of patients with persistent or recurrent cutaneous T-cell lymphoma (CTCL). I/ONTAK is a purified and more bioactive formulation of previously FDA-approved ONTAK®. The PDUFA target action date is September 28, 2023. The BLA is supported by a pivotal Phase 3 study (NCT01871727).

"The acceptance of the previously announced BLA submission for I/ONTAK is another important regulatory milestone for our oncology program. With an anticipated PDUFA date of September 28, 2023, we look forward to the potential approval of this therapeutic for patients with persistent or recurrent cutaneous T-cell lymphoma, a rare disease for which patients with advanced disease have limited treatment options," stated Leonard Mazur, Chairman and CEO of Citius.

Read the full article here.

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No. 4 CTXR Potential Catalyst - Trading Above Key Support Lines Could Mean Big Things Ahead Near Term

Take a look at CTXR's 6-month chart real quick:

image

Since the year kicked off, CTXR has been on a tear and that could mean important things in the near term.

With this recent surge that has seen CTXR climb approximately 78% from its low of 2023 to its high Wednesday, this Nasdaq idea has moved above 3 key lines of potential support.

Those are its:

  • 50-Day Simple Moving Average (SMA)
  • 200-Day SMA
  • 13-Day Exponential Moving Average (EMA)

If potential support continues to grow at those levels, it could help CTXR to run down previous highs it set over the past 12-month stretch when it traded as high as $2.00.

Now, I'm not saying CTXR is going to surge to $2.00 this week, but the potential upside needs to be noted along with this current hot start to the year.

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CTXR Recap - 4 Key Potential Catalysts For This Nasdaq Past Champ

No. 1 - A $10 Analyst Target Paints The Possibility For An Exceptionally Bright Future

No. 2 - Corporate Update Provides Glimpse Of How Big 2023 Could Be For CTXR

No. 3 - FDA Accepts Company's BLA For E7777, Target Action Date For PDUFA In September

No. 4 - Trading Above Key Support Lines Could Mean Big Things Ahead Near Term

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Coverage is officially reinitiated on CTXR. When you have time later, do this:

image

Get CTXR on your radar now.

Sincerely,

Kai Parker

StockWireNews


(Always Remember The Stock Prices Could Be Significantly Lower Now From The Dates I Provided.)

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Pursuant to an agreement between StockNewsWire LLC and Venado Media LLC, StockWireNews was hired for a period beginning on 7/26/19 and ending on 7/29/19 to publicly disseminate information about (CTXR) via Website, Email and SMS. We were paid twenty thousand USD via bank wire transfer. We own zero shares of (CTXR). Pursuant to an agreement between StockNewsWire LLC and Venado Media LLC, StockWireNews has been hired for a period beginning on 9/3/19 and ending on 9/4/19 to publicly disseminate information about (CTXR) via Website, Email and SMS. We were paid twenty thousand USD via bank wire transfer. We own zero shares of (CTXR). Pursuant to an agreement between StockNewsWire LLC and Venado Media LLC, StockWireNews has been hired for a period beginning on 12/18/19 and ending on 12/19/19 to publicly disseminate information about (CTXR) via Website, Email and SMS. We were paid twenty thousand USD via bank wire transfer. We own zero shares of (CTXR). Pursuant to an agreement between StockNesWire LLC and Venado Media LLC, StockWireNews has been hired for a one day period on 2/4/20 to publicly disseminate information about (CTXR) via Website, Email and SMS. We were paid twenty thousand USD via bank wire transfer. We own zero shares of (CTXR). Pursuant to an agreement between StockNewsWire LLC and Venado Media LLC, StockWireNews has been hired for a one day period on 3/11/20 to publicly disseminate information about (CTXR) via Website, Email and SMS. We were paid seven thousand five hundred USD via bank wire transfer. We own zero shares of (CTXR). Pursuant to an agreement between StockNewsWire LLC and Venado Media LLC, StockWireNews has been hired for a period beginning on 4/2/20 and ending on 4/3/20 to publicly disseminate information about (CTXR) via Website, Email and SMS. We were paid twenty-five thousand five hundred USD via bank wire transfer. We own zero shares of (CTXR). 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