Jumat, 19 Desember 2025

(Nasdaq: CTOR) Climbs Our Watchlist As Commercialization Efforts Accelerate (5 Potential Catalysts)

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(Nasdaq: CTOR) Climbs Our Watchlist As Commercialization Efforts Accelerate (5 Potential Catalysts)


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December 19th

Greetings Readers,


Potentially flying under-the-radar, a leading pharma company has just closed an $18Mn concurrent registered direct offering and private placement, a strategic move aligned under Nasdaq rules.


This infusion of proceeds will help accelerate the commercial launch of its recently approved therapy, LYMPHIR, aimed at addressing critical needs in patient care.


The timing of this announcement underscores the company’s commitment to bringing innovative treatments to market efficiently and effectively.


With commercialization now well underway, this financing marks an important milestone for a team clearly focused on execution and long-term growth in the immunotherapy space.


And with a low float meaning volatility potential could be significantly heightened on a daily basis and an analyst target pointing to triple-digit potential upside, this little-known Nasdaq idea tops my watchlist:


Citius Oncology, Inc. (Nasdaq: CTOR)


Citius Oncology, Inc. is a platform to develop and commercialize novel targeted oncology therapies.


In August 2024, its primary asset, LYMPHIR, was approved by the FDA for the treatment of adults with relapsed or refractory Stage I–III CTCL who had had at least one prior systemic therapy.


Management estimates the initial market for LYMPHIR currently exceeds $400Mn, is growing, and is underserved by existing therapies. (1)


And based on several potential catalysts, (Nasdaq: CTOR) has catapulted to the top of our watchlist. Check them out:


#1. Could A Very Low Float Create An Environment For Heightened Volatility Potential?


#2. The Company Announces $18Mn Closing Of Registered Direct Offering And Private Placement (Net Proceeds To Support LYMPHIR Commercial Launch).


#3. A Major Milestone Notched As Company Announces Launch Of LYMPHIR.


#4. A Key Agreement Represents A Significant Milestone In The Company's Global Expansion Strategy.


#5. A Maxim Group Analyst Tags CTOR With A $6 Target.


But more on those in a second...


About Citius Oncology, Inc.


Company focused on developing and commercializing innovative targeted oncology therapies 


1.) Lead product, LYMPHIR, FDA approved August 2024


  • Orphan Indication: treatment of adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy


  • 12-year BLA exclusivity


  • First new systemic CTCL therapy since 2018 


2.) Commercialization has officially launched as of December 2025


3.) Estimated $400Mn+ addressable U.S. market with growth opp's(1)


4.) Publicly traded on NASDAQ since August 2024 (Ticker: CTOR)

Lymphir Is Now Commercially Available In The United States

What Is Cutaneous T-Cell Lymphoma (CTCL)?


Considered to be incurable, CTCL is a Subgroup of Non-Hodgkin Lymphomas (NHL) that can be Indolent or Aggressive and is Driven by Malignant T Cells

Patients with persistent or recurrent CTCL require systemic therapy.


1. Dummer R, et al. Nat Rev Dis Primers. 2021;7(1):61. 2. Rangoonwala, HI and Cascella M. 2022, StatPearls Publishing: Treasure Island, FL. 3. Cleveland Clinic. Cutaneous T-Cell Lymphoma. 2023. Available from: https0://my.clevelandclinic.org/health/diseases/17940-cutaneous-t-cell-lymphoma 4. Hristov AC, et al. Am J Hematol. 2019;94(9):1027-1041

Compelling Clinical Data


LYMPHIR addresses CTCL’s heavy Quality of Life burden

1. Objective Response is Complete Response and Partial Response according to the ISCL/EORTC Global Response Score. 2. In the Primary Efficacy Analysis set, 84.4% (54/64) of skin evaluable subjects had a decrease in skin tumor burden, with 48.4% subjects with ≥50% reduction in skin tumor burden. Complete clearing of skin disease (skin CR) was observed in 12.5% (8/64)subjects. 3. The duration of response (DOR) was at least 6 months for 52% of responders and at least 12 months for 20% of responders (25/69 patients).

Opp's For Growth Beyond Cutaneous T-cell Lymphoma (CTCL)


University of Pittsburgh: an investigator-initiated trial is underway to evaluate LYMPHIR for potential use as an immuno-oncology therapy in combination with KEYTRUDA® in patients with recurrent or metastatic solid tumors (NCT05200559)


Encouraging preliminary results of interim analysis:


  • 15 evaluable patients showed 27% ORR; 33% Clinical Benefit Rate; median Progression Free Survival of 57 weeks (for patients that achieved a clinical benefit).


The data supports further evaluation of this combination across a broader range of solid tumor types.


Phase 1 Preliminary study data (n=25) anticipated Q4 2025/Q1 2026.


University of Minnesota: LYMPHIR in combination with CAR T therapies (NCT04855253)


Phase 1 study to evaluate the potential benefit of LYMPHIR given prior to CAR T therapy in patients with high risk relapsed/refractory B-cell lymphomas.


Preliminary study results anticipated Q1 2026.


Logical label expansion potential in PTCL where there is a high unmet need and no curative therapies.

1. KEYTRUDA is a registered trademark of Merck & Co., Inc. KYMRIAH is a registered trademark of Novartis Pharmaceuticals Corporation.


Grab Sources And More Here: CTOR Presentation.

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And as I mentioned previously, (Nasdaq: CTOR) has several potential catalysts helping catapult it to the top of our watchlist. Take a look:


#1. CTOR Potential Catalyst - Could A Very Low Float Create An Environment For Heightened Volatility Potential?


According to the Yahoo Finance website, CTOR has a very low float.


In fact, the website reports this profile to have approximately 3.44Mn shares in its float.


Why is that important? It's important on one crucial level. Volatility potential.


Could even more positive company news at the end of 2025 provide a breakout spark when paired with this volatility potential?

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#2. CTOR Potential Catalyst - The Company Announces $18Mn Closing Of Registered Direct Offering And Private Placement (Net Proceeds To Support LYMPHIR Commercial Launch).


Citius Oncology Announces Closing of $18Mn Concurrent Registered Direct Offering and Private Placement Priced At-The-Market Under Nasdaq Rules


CRANFORD, N.J., Dec. 10, 2025 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology" or the "Company") (Nasdaq: CTOR), ..., today announced the closing of its previously announced registered direct offering with a single healthcare-focused in-vest-or, priced at-the-market under Nasdaq rules, for the purchase and sale of 1,284,404 shares of its common st-ock at a purchase price of $1.09 per share. In addition, the Company issued to the in-vest-or unregistered warrants to purchase up to 1,284,404 shares of common st-ock at an exercise price of $1.09 per share, which will be exercisable beginning on the effective date of st-ockholder approval of the issuance of the shares of common st-ock upon exercise of the warrants and will expire five years from the date of st-ockholder approval.


The Company also closed its previously announced private placement, priced at-the-market under Nasdaq rules, for the purchase and sale of 15,229,358 shares of common st-ock (or pre-funded warrants in lieu thereof) and warrants to purchase up to 15,229,358 shares of the Company's common st-ock at a purchase price of $1.09 per share and accompanying warrant. The warrants issued in the private placement have an exercise price of $1.09 per share, will be exercisable beginning on the effective date of st-ockholder approval of the issuance of the shares of common st-ock upon exercise of the warrants, and will expire five years from the date of st-ockholder approval.


H.C. Wainwright & Co. acted as the exclusive placement agent for the offerings.


The gross proceeds from the offerings, before deducting the placement agent's fees and other offering expenses payable by the Company, were approximately $18Mn. The Company intends to use the net proceeds from the offerings to support the commercial launch of LYMPHIR and for working capital and general corporate purposes.


...


Read the full article here.

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#3. CTOR Potential Catalyst - A Major Milestone Notched As Company Announces Launch Of LYMPHIR.


Citius Oncology Announces U.S. Commercial Launch of LYMPHIR™, a Novel Cancer Immunotherapy for Cutaneous T-Cell Lymphoma (CTCL)


LYMPHIR now available nationwide


CRANFORD, N.J., Dec. 1, 2025 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), ..., today announced the commercial launch of LYMPHIR™ (denileukin diftitox-cxdl). LYMPHIR is a novel IL-2 receptor-directed fusion protein approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory (r/r) Stage I–III cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.


"LYMPHIR is an important new treatment option for the CTCL community, and its launch marks the beginning of a new chapter for Citius Oncology. With a median time to response of 1.4 months in the Phase 3 trial, we believe LYMPHIR may offer rapid skin relief, among other benefits, to patients suffering from severe and debilitating itching common with the disease," said Leonard Mazur, Chairman and CEO of Citius Oncology... "This is our first marketed product and the culmination of years of development work and commercial preparation. LYMPHIR addresses a clear clinical need in a disease with limited treatment options. Ultimately, we expect LYMPHIR to be a meaningful addition to the treatment paradigm for CTCL and a value-driving catalyst for Citius Oncology shareholders. We estimate that LYMPHIR is entering a growing U.S. market valued at over $400Mn, with further upside opp's through international market access and potential expanded indications in the future. Our focus now is on execution to ensure that LYMPHIR reaches the patients who need it," added Mazur.


The FDA approval of LYMPHIR was based on data from Pivotal Study 302 (NCT01871727), which evaluated the efficacy and safety of LYMPHIR in patients with Stage I–III CTCL who had received at least one prior systemic treatment. The study demonstrated an Objective Response Rate (ORR) of 36.2%, with 84% of evaluable patients experiencing a reduction in skin tumor burden. Moreover, LYMPHIR demonstrated meaningful activity on severe pruritus (itchiness), a significant quality of life issue for CTCL patients. Median time to response was 1.4 months. Importantly, LYMPHIR was not associated with cumulative toxicity.


"LYMPHIR is an important new tool in the fight against CTCL. It is the only FDA-approved systemic therapy for CTCL in more than seven years," said Dr. Myron Czuczman, Executive Vice President and Chief Medical Officer of Citius Oncology... . "LYMPHIR's direct tumoricidal activity and transient T-regulatory cell depletion offer a powerful new approach to disease control without cumulative toxicity. As such, LYMPHIR's clinical profile makes it a compelling treatment option for physicians and patients facing the burden of relapsed or refractory CTCL."


...


Read the full article here.

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#4. CTOR Potential Catalyst - A Key Agreement Represents A Significant Milestone In The Company's Global Expansion Strategy.


Citius Oncology Expands LYMPHIR™ Distribution to Turkey and Middle East Countries Through Exclusive Agreement with Er-Kim


Partnership expands access to LYMPHIR for patients with cutaneous T-cell lymphoma across Turkey, Bahrain, Qatar, Oman, Kuwait, Saudi Arabia, and the UAE


LYMPHIR international availability extends to 19 markets outside the U.S.


CRANFORD, N.J., Dec. 4, 2025 /PRNewswire/ -- Citius Oncology, Inc. ("Citius Oncology") (Nasdaq: CTOR), ..., today announced that it has entered into an exclusive distribution agreement with Er-Kim İlaç Sanayi ve Ticaret A.Ş. ("Er-Kim"), a leading pharmaceutical distributor based in Turkey, for LYMPHIR (denileukin diftitox-cxdl), a novel IL-2 receptor-directed cytotoxin, approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory Stage I-III cutaneous T-cell lymphoma after at least one prior systemic therapy. Under the terms of the agreement, Er-Kim will be the exclusive distributor of LYMPHIR in Turkey and key Gulf Cooperation Council (GCC) countries, including Bahrain, Qatar, Oman, Kuwait, Saudi Arabia, and the United Arab Emirates.


The agreement expands Citius Oncology's international strategy to a total of 19 markets outside the U.S. leveraging Named Patient Programs. These programs provide access, where permitted by local law, and do not constitute commercial approval of LYMPHIR outside the United States. In October 2025, Citius Oncology announced access to LYMPHIR in Greece, Cyprus, Malta, Bulgaria, Romania, Croatia, Serbia, Albania, Bosnia Herzegovina, Kosovo, Montenegro and North Macedonia.


"This agreement represents a significant milestone in our global expansion strategy," said Leonard Mazur, Chairman and CEO of Citius Oncology... . "Er-Kim has deep industry experience and a strong track record of providing access to oncology therapies in complex international markets. Their local expertise and regulatory capabilities make them an ideal partner as we work to expand access to LYMPHIR in support of patients and providers across Turkey and the GCC."


...


Read the full article here.

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#5. CTOR Potential Catalyst - A Maxim Group Analyst Tags CTOR With A $6 Target.


The Maxim Group has built one of the premier proprietary research platforms on Wall Street, with an emphasis on small-cap, micro-cap, and emerging growth companies.


Michael Okunewitch, an analyst at Maxim Group covering the biotechnology sector, has suggested a $6.00 target for Citius Oncology as of 12/18/25 according to published info on the company’s website.


With this $6.00 target, there could be upside potential of over 400% for CTOR from its closing valuation Thursday.

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(Nasdaq: CTOR) Recap - These 5 Potential Catalysts Could Draw Serious Buzz


#1. Could A Very Low Float Create An Environment For Heightened Volatility Potential?


#2. The Company Announces $18Mn Closing Of Registered Direct Offering And Private Placement (Net Proceeds To Support LYMPHIR Commercial Launch).


#3. A Major Milestone Notched As Company Announces Launch Of LYMPHIR.


#4. A Key Agreement Represents A Significant Milestone In The Company's Global Expansion Strategy.


#5. A Maxim Group Analyst Tags CTOR With A $6 Target.

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We're officially kicking-off coverage on Citius Oncology, Inc. (Nasdaq: CTOR).


Be on the lookout for updates coming your way shortly. Talk soon.


Sincerely,

Kai Parker

StockWireNews


Sources: 1.) Internal CTOR estimates based on IQVIA market research


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


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