Hot Off the Press: Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) Trial Shows Promising Results in Cancer Treatment

* Sponsored  Kicking off a new week, we’re shifting focus from Friday’s 672% (approx) pre-market move to a biotech with recent FDA approval for a breakthrough cancer therapy! Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is #1 on Our Watchlist Today! Here’s Why… Recent Market Recognition: leading to an approximate 42% move in under three days last week, could indicate the potential for bullish momentum for Citius Pharmaceuticals, Inc. (Nasdaq: CTXR)! Analyst Coverage: EF Hutton (now D. Boral Capital) initiated coverage on Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) with a $6.00 target, suggesting over 1,358% potential upside! FDA-Approved Cancer Therapy: Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) recently secured FDA approval for LYMPHIR™ as a treatment for CTCL, enhancing its presence in oncology. Consider adding Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) to the top of your watchlist today! November 11, 2024 Dear Reader, We have some hot off the press news out of Citius Pharmaceuticals, Inc. (Nasdaq: CTXR). Citius Pharmaceuticals (Nasdaq: CTXR) has unveiled promising preliminary findings from a Phase I clinical trial investigating a combination treatment using pembrolizumab and LYMPHIR™ in patients with recurrent solid tumors.  Early data from this trial show encouraging results, with a 27% Objective Response Rate (ORR) and a 33% Clinical Benefit Rate (CBR), alongside a median progression-free survival of 57 weeks.  These results highlight LYMPHIR’s potential in enhancing the anti-tumor effects of immune checkpoint inhibitors, especially in patients who have previously undergone checkpoint therapy.  Importantly, the regimen has been well tolerated with minimal immune-related adverse events, supporting the combination's potential for future expanded research in treating solid tumors.  These findings were presented at the Society for Immunotherapy of Cancer’s (SITC) 2024 Annual Meeting. Biopharma is one of the rare sectors where a small company can become a big name almost overnight. With a newly “FDA Approved” therapy ready to potentially disrupt the field and a robust pipeline of treatments, Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is one Biopharma to keep an eye on. Since receiving FDA approval, Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) has been moving quickly to launch LYMPHIR™—a promising therapy for lymphoma that offers a new approach for patients.  This unique therapy is gaining recognition for its potential to address an underserved area in oncology. Citius Pharmaceuticals, Inc. (Nasdaq: CTXR)’s dedication to advancing other late-stage treatments only strengthens their standing as an emerging player in biotech.  Last week, Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) moved approximately 42% in under 3 days. In doing so, (CTXR) surpassed several key moving averages including the following: 5-Day : $.3679 20-Day: $.3750 After Friday’s close, (CTXR) ticked up approximately 2% after hours.   Not to mention, EF Hutton (now D. Boral Capital), a firm with a track record of over 500 global transactions and $250B in public and private market financing, has initiated coverage on Citius Pharmaceuticals (NASDAQ: CTXR) with a bullish target of $6.00—suggesting a potential upside of over 1,358%. Keep reading to see why Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is #1 on our watchlist today… Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is a biopharmaceutical company innovating in critical care, with a focus on developing first-in-class therapeutics for cancer, infectious diseases, and hemorrhoidal relief.  The company has made significant strides in 2024, marked by the FDA approval of LYMPHIR™ (denileukin diftitox-cxdl), a targeted immunotherapy for cutaneous T-cell lymphoma (CTCL), and the completion of late-stage clinical trials for their leading products: Mino-Lok® and CITI-002 (Halo-Lido).  LYMPHIR™, which uniquely targets the interleukin-2 (IL-2) receptor on malignant T-cells, provides a new treatment for CTCL, an underserved area with a growing market projected to exceed $400M .  Citius’s subsidiary, focused on targeted oncology therapies, will also commercialize LYMPHIR™, expanding its reach and impact in cancer treatment. LYMPHIR™ and the Oncology Landscape Citius Oncology achieved a breakthrough when LYMPHIR™ received FDA approval in August 2024, specifically for relapsed or refractory CTCL patients.  LYMPHIR’s mechanism of action, targeting the IL-2 receptor on malignant T-cells and immunosuppressive regulatory T cells, enhances its efficacy by both eliminating malignant cells and modulating immune responses. Its addition to the National Comprehensive Cancer Network (NCCN) Guidelines represents a validation of its clinical value and expands its adoption in treatment protocols, especially for patients eligible for Medicare and Medicaid. Beyond CTCL, Citius Oncology is exploring LYMPHIR’s potential in combination with immune checkpoint inhibitors. Preclinical studies have demonstrated that LYMPHIR, when combined with anti-PD-1 therapies, improves survival in solid tumor models.  Clinical trials at the University of Minnesota and the University of Pittsburgh aim to investigate these combinations further, setting the stage for LYMPHIR’s expansion into broader oncology applications. Pipeline Highlights Mino-Lok® (Antibiotic Lock Solution): Mino-Lok® addresses catheter-related bloodstream infections (CRBSIs), a life-threatening complication associated with central venous catheters (CVCs). CRBSIs affect over 500K patients annually in the U.S., with no current FDA-approved solutions for catheter salvage.  Mino-Lok® met primary and secondary endpoints in its Phase 3 trial, demonstrating a superior median time to catheter failure compared to standard antibiotic lock solutions.  Given its ability to sterilize CVCs without removal, Mino-Lok® has the potential to become the standard of care for CRBSIs, with an estimated $2B global market. CITI-002 (Halo-Lido) for Hemorrhoidal Relief: CITI-002, combining halobetasol and lidocaine, is undergoing Phase 2 trials and shows promise as a topical treatment for hemorrhoidal symptoms, which affects mil-lions globally. Should it proceed to Phase 3, CITI-002 could become the first FDA-approved prescription product in this market, capturing a share of the $2B U.S. hemorrhoid treatment market. Fiscal and Growth Potential Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) continued its robust momentum into the third quarter of 2024, achieving significant clinical and corporate milestones.  The FDA approved LYMPHIR™ (denileukin diftitox-cxdl) as a treatment for cutaneous T-cell lymphoma (CTCL), setting the stage for Citius's shift from development to commercialization.  Additionally, Citius completed a merger with TenX Keane Acquisition, launching its oncology subsidiary as a separate, publicly traded entity.  This strategic move enables both companies to pursue specialized growth paths, with LYMPHIR’s anticipated Q4 launch already in preparation. Alongside these developments, Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) also saw success with Mino-Lok®, which met primary and secondary endpoints in its Phase 3 Pivotal Trial. Designed to salvage central venous catheters in patients with bloodstream infections, Mino-Lok® offers a potential breakthrough in infection management.  The company has continued discussions with the FDA to advance Halo-Lido, a treatment for hemorrhoids, into the next stages of development. Strength and Operational Preparedness Citius strengthened its position with a $15M offering completed in April, bringing its cash and cash equivalents to $17.9M as of June 30, 2024.  These funds are projected to sustain operations through December 2024, with the company actively exploring further capital sources to extend its financial runway beyond this period. For the quarter ended June 30, 2024, research and development expenses were $2.8M , down from $3.8M the previous year, due to reduced costs following the completion of the Mino-Lok® trial.  General and administrative expenses rose to $4.8M , reflecting increased investments in pre-launch activities for LYMPHIR.  As Citius Pharmaceuticals, Inc. (Nasdaq: CTXR)  prepares for LYMPHIR’s market entry and the continued development of Mino-Lok® and Halo-Lido, the company remains strategically focused on resource optimization and operational readiness. With these achievements, Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is positioned for a transformative period as it advances its late-stage therapies and prepares for commercialization, making it a compelling company to monitor in the biopharma sector. Market Growth Strategy Citius Pharmaceuticals is targeting multi-bill-ion-dollar global markets with high unmet needs: CRBSI/CLABSI Market: Projected at over $1.8B globally. CTCL Market: Estimated at $300-$400M in the U.S., with potential for further expansion into PTCL and immuno-oncology. Hemorrhoidal Treatment Market: Estimated over $2B in the U.S. The experienced management team, led by Chairman, CEO, and Co-Founder Leonard Mazur, includes notable figures in biopharma and healthcare.  The leadership team brings decades of experience and a proven track record, further supporting the company’s clinical and commercial endeavors. With LYMPHIR™ on the brink of reshaping CTCL care and a range of critical therapies in development, Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) has the potential to gain ground in the biopharma arena. The company’s forward-looking strategy, robust R&D pipeline, and commitment to advancing patient care uniquely position it for long-term growth in the biopharmaceutical industry. 5 reasons why Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is #1 on our watchlist today… 1. Recent Market Recognition: Last week, Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) saw an approximate 42% move over three days. This sharp increase reflects growing market interest in the company’s achievements and upcoming product launches. 2. Analyst Coverage: Analysts at EF Hutton (now D. Boral Capital) have initiated coverage on Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) with a $6.00 target, which suggests over 1,358% in potential upside. 3. FDA-Approved Cancer Therapy: Just a few months ago, Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) secured FDA approval for LYMPHIR™ as a treatment for CTCL. This achievement marks a relatively recent milestone, solidifying the company’s growing role in oncology. 4. Strategic Spin-Off: Citius successfully spun off its oncology division through a merger, creating another company of which they own 90%. This restructuring allows each division to focus on distinct paths, amplifying growth potential in both critical care and oncology. 5. Pipeline with Diverse Market Reach: Beyond LYMPHIR™, Citius’s late-stage assets like Mino-Lok® and CITI-002 (Halo-Lido) target other high-need areas, including infections and hemorrhoidal relief, tapping into markets valued at over $1.8B and $2B, respectively. Consider adding Citius Pharmaceuticals, Inc. (Nasdaq: CTXR)  to your radar this week… With recent market recognition driving an approximate 42% move in under three days last week, along with an analyst’s $6 target suggesting over 1,358% potential upside, Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is one little-known biotech to have on your radar. The company’s FDA approval for LYMPHIR™ as a CTCL treatment only a few months ago underscores its commitment to oncology, while the recent spin-off amplifies its focus on high-impact treatments across both critical care and cancer. Backed by a diverse pipeline addressing bill-ion-dollar markets, Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is making strategic moves to maximize growth in infectious disease and hemorrhoidal relief therapies, with Mino-Lok® and Halo-Lido expected to follow LYMPHIR™ in upcoming commercialization efforts.  With the anticipated Q4 launch of LYMPHIR™, Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is positioning itself for a transformative phase in the biopharma sector. Make no mistake! Citius Pharmaceuticals, Inc. (Nasdaq: CTXR) is #1 on our watchlist today.  And don’t miss the hot off the press news about how Citius Pharmaceuticals, Inc. (Nasdaq: CTXR)’s early cancer trial results show significant promise. I’ll check back in with you shortly. Sincerely, Gary Silver Managing Editor, MarketCrux MarketCrux.com (“MarketCrux” or “MC” ) is owned by Headline Media LLC, a multi member limited liability company. Data is provided from third-party sources and MarketCrux is not responsible for its accuracy. 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