Monday, September 23, 2024

On Immediate Alert: Nasdaq Biopharma (CTOR) Is A Low Float Profile Riding A Recent FDA Approval

Hitting my desk, an under-the-radar biopharma company caught my attention over the weekend.

StockWireNews

On Immediate Alert: Nasdaq Biopharma (CTOR) Is A Low Float Profile Riding A Recent FDA Approval

A Low Float (Approx. 350k Shares) Means Strong Volatility Potential!

September 23rd

Greetings Readers,

Hitting my desk, an under-the-radar biopharma company caught my attention over the weekend.

Why is this one special? Simple. FDA approval.

This company's lead product recently received FDA approval for treating relapsed or refractory CTCL, addressing a critical gap in patient care.

Positioned to shake up an untapped industry, this breakthrough targets a market potentially valued at more than $400Mn (and growing).

Strong intellectual property protections and plans to expand into immuno-oncology combination therapies should enhance this company's competitive edge.

Now may be the perfect time to dive deeper and explore what this emerging leader in oncology has to offer.

Oh. By the way, if you like low float profiles, this one could blow your mind.

Right now, Finviz is reporting a float of roughly 350k shares!

That means that volatility could become an explosive dynamic when tracking this newly minted Nasdaq profile.

Listen. Time's ticking to pull up:

Citius Oncology, Inc. (Nasdaq: CTOR)

Citius Oncology, Inc. is a biopharmaceutical company focused on developing and commercializing innovative targeted oncology therapies.

In August 2024, the U.S. Food and Drug Administration (FDA) approved LYMPHIR™ (denileukin diftitox-cxdl), their targeted immune therapy for patients with relapsed or refractory cutaneous T-cell lymphoma (CTCL).

(Nasdaq: CTOR) - The Game-Changing Announcement

Last month, this huge news appears to have flown under-the-radar. Check it out:

Citius Pharmaceuticals* Receives FDA Approval for LYMPHIR™ Immunotherapy for the Treatment of Adults with Relapsed or Refractory Cutaneous T-Cell Lymphoma

  • Only systemic treatment for relapsed or refractory (r/r) CTCL to target the IL-2 receptor on malignant T-cells and Tregs
  • LYMPHIR is expected to launch within the next five months
  • LYMPHIR's approval marks the first novel targeted systemic therapy approved by the FDA r/r CTCL since 2018
  • Approval based on Phase 3 Pivotal Study 302 results that demonstrated 36% ORR, reduction in skin disease in 84% of patients, clinically significant pruritis improvement, and no cumulative toxicity

CRANFORD, N.J., Aug. 8, 2024 /PRNewswire/ -- Citius Pharmaceuticals, Inc. (NASDAQ: CTXR) ("Citius", "Citius Pharma"), announced today that the U.S. Food and Drug Administration (FDA) has approved LYMPHIR™ (denileukin diftitox-cxdl), a novel immunotherapy for the treatment of r/r cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy. LYMPHIR is the only CTCL therapy that targets the interleukin-2 (IL-2) receptor found on malignant T-cells and Tregs. This is the first indication for LYMPHIR and the first FDA-approved product for Citius Pharma.

image

"LYMPHIR offers new hope for patients suffering from cutaneous T-cell lymphoma, a rare and chronic cancer characterized by debilitating skin lesions and severe itching. This approval is a significant milestone for CTCL patients. The introduction of LYMPHIR, with its potential to rapidly reduce skin disease and control symptomatic itching without cumulative toxicity, is expected to expand the CTCL treatment landscape and grow the overall market, currently estimated to be $300-$400Mn," stated Leonard Mazur, Chief Executive Officer of Citius Pharmaceuticals.

"We are grateful to the clinicians, patients, and researchers who contributed to the development of LYMPHIR. We believe LYMPHIR's unique IL-2 receptor-targeted treatment, which kills tumor cells directly, and concurrently depletes host Tregs in order to boost the body's immune response, is an important differentiator and offers clinically meaningful benefits to a significant percentage of r/r patients. As the only IL-2 receptor-targeted immunotherapy for CTCL, LYMPHIR provides a novel and non-cross-resistant treatment option without cumulative toxicity for Stage I-III r/r patients for whom symptomatic skin involvement interferes with their daily quality of life. LYMPHIR's median time-to-response of only 1.4 months (min, max: 0.7, 5.6) offers many patients rapid skin relief," added Dr. Myron Czuczman, Chief Medical Officer of Citius Pharmaceuticals.

...

"As a treating oncologist, I have seen the profound negative effect on the quality of life in patients with r/r CTCL. Given the long-term nature of the disease, pruritus, ulceration of the tumors, and secondary pyogenic skin infection, it is vital to get this skin involvement under control. LYMPHIR is the first therapeutic option in many years to offer hope of reducing skin disease, bringing us one step closer to filling the need for CTCL patients, particularly those that are not able to complete or continue prior therapies," stated Dr. Francine Foss, Professor of Hematology and Director of the Multidisciplinary T-cell Lymphoma Program at Yale Cancer Center, New Haven, CT.

...

Read the full article here.

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The Citius Oncology, Inc. (Nasdaq: CTOR) Pipeline

Citius Oncology is focused on developing and commercializing LYMPHIR™ (denileukin diftitox-cxdl), a targeted immune therapy for an initial indication in the treatment of persistent or recurrent cutaneous T-cell lymphoma (CTCL), a rare form of non-Hodgkin lymphoma. LYMPHIR is a specially engineered IL-2-diphtheria toxin fusion protein made using recombinant DNA technology. It works by targeting cells that have IL-2 receptors with a toxin derived from diphtheria bacteria. Once inside the cell, this toxin stops the cell from making proteins, which leads to the cell's death. LYMPHIR has two main effects:

  • Directly kills tumor cells: It binds to IL-2 receptors and internalizes the diphtheria toxin directly into the tumor cells, causing them to die.
  • Boosts the immune response: It reduces the number of regulatory T cells (Tregs) that suppress the immune system, thereby enhancing the body's ability to fight the tumor.

How It Works

Cutaneous T-cell Lymphoma (CTCL)

CTCL is a subset of non-Hodgkin lymphomas predominantly affecting the skin. The most common types include Mycosis Fungoides (MF) and Sézary Syndrome (SS). Approximately 30,000 to 40,000 patients live with CTCL in the U.S., with an estimated annual incidence rate of 0.5/100,000 according to the National Cancer Institute.

CTCL is a chronic disease. Despite existing therapeutic options to treat the disease, there remains a significant unmet medical need due to limitations in current treatments, such as toxicity and resistance. Available systemic agents are not curative, and the primary focus of treatment is to induce and maintain remission.

LYMPHIR is a novel targeted oncology asset with an attractive near-term revenue opp. LYMPHIR is now FDA approved. It is the only recombinant fusion protein in the CTCL treatment landscape.

Program Highlights

  • Phase 3 Pivotal trial completed December 2021.
  • The FDA approved LYMPHIR on August 7, 2024.

Important safety information and LYMPHIR's full prescribing information may be accessed here.

Citius Oncology plans to further explore the potential of LYMPHIR to treat larger patient populations with additional indications in peripheral T-cell lymphoma (PTCL) and immuno-oncology.

Find Key Source Details Here: CTOR Website.

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(Nasdaq: CTOR) A Tiny Float Idea (Explosive Potential On Notice)

The subject above says it all. CTOR's float is minuscule.

Finviz is reporting a float in the neighborhood of 350k shares!

What does this mean? Good question. It means volatility will need to be watched-for incredibly closely.

When a profile has a float in this incredibly small range, a potential catalyst, like company news (whether good or bad), can have a dramatic impact on chart movements.

Take a look at August 13th on CTOR's chart. There was a $1.00+ surge from its open to its high of day that session.

Volatility can create the type of an environment for such chart moves.

Now, that's not to say CTOR is going to go surging this coming week, but with recent FDA approval and this major news announcement from early September, it may just be a matter of time until Wall Street starts taking Citius Oncology, Inc. seriously.

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(Nasdaq: CTOR) is now on high alert! Get it on your radar quickly.

Sincerely,

Kai Parker

StockWireNews

*Citius Pharmaceuticals, Inc. (CTXR:US) was previously profiled by SWN Media LLC, where SWN Media LLC was compensated to publicly disseminate information about (CTXR:US) via digital communications.


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

StockWireNews (stockwirenews . com) is owned by SWN Media LLC, a limited liability company. Data is provided from third-party sources and SWN is not responsible for its accuracy. Make sure to always do your own research and due diligence on any day and swing profile I bring to your attention. Any emojis used do not have a specific defined meaning, and may be used inconsistently. We do not provide personalized fin.ancial advice, are not finan.cial advisors, and our opinions are not suitable for all in.vest.ors. Please review our full disc-laim-er here: www.stockwirenews.net/disclosure An owner of SWN Media LLC owns and operates smallcapfirm . com ("SCF"), owns and operates fierceinvestor . com ("FI"), and owns and operates stockstreetwire . com ("SSW"). From time to time, StockWireNews, SCF, FI, and/or SSW will publicly disseminate information about a company via website, email, SMS and other points of media. Pursuant to an agreement between SWN Media LLC and TD Media LLC, StockWireNews was hired for a period beginning on 9/22/24 and ending on 9/23/24 to publicly disseminate information about (CTOR:US) via Website, Email and SMS. SWN Media LLC was paid fifteen thousand USD via bank wire transfer. We own zero shares of (CTOR:US). A member of SWN Media LLC is also a member of TD Media LLC. Citius Oncology, Inc. (CTOR:US) is a subsidiary of Citius Pharmaceuticals, Inc. (CTXR:US). Citius Pharmaceuticals, Inc. (CTXR:US) was previously profiled by TD Media LLC, where TD Media LLC was compensated to publicly disseminate information about (CTXR:US) via digital communications. Pursuant to an agreement between TD Media LLC and Sica Media LLC, TD Media LLC has been hired for a period beginning on 09/22/2024 and ending on 09/23/2024 to publicly disseminate information about (CTOR:US) via digital communications. We have been paid thirty thousand USD via bank wire transfer. We own zero shares of (CTOR:US). https://lifewatermedia.com/ctor-disclosure-8976/

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