Latest news with #CelldexTherapeutics
Business Upturn
7 days ago
- Health
- Business Upturn
Celldex Presents Data Demonstrating Profound Long Term Improvement in Angioedema in Barzolvolimab Phase 2 Study in Chronic Spontaneous Urticaria at EAACI 2025
77% of patients (150 mg Q4W) treated with barzolvolimab who had angioedema at baseline were angioedema free at Week 52 (150 mg Q4W) Data further support barzolvolimab clinical benefit to patients with CSU HAMPTON, N.J., June 14, 2025 (GLOBE NEWSWIRE) — Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced data demonstrating that barzolvolimab profoundly improves angioedema at 52 weeks in the Company's Phase 2 clinical trial in chronic spontaneous urticaria (CSU). Angioedema, characterized by swelling of the deeper dermal layers of the skin and mucous membranes, is a painful, debilitating symptom of CSU that has significant impact on quality of life. It commonly affects the face (lips and eyelids), hands, feet, and genitalia but can also involve the tongue, uvula, soft palate, and pharynx1. The data were presented today by Dr. Martin Metz, Professor, Department of Dermatology and Allergy, Head of Translational Research and Deputy Head of Clinical Trials at Charité – Universitätsmedizin in Berlin, in an oral presentation at the European Academy of Allergy and Clinical Immunology (EAACI) Congress 2025. Celldex previously announced that the Phase 2 study in CSU met its primary and secondary endpoints at 12 weeks with clinically meaningful and statistically significant decreases in UAS7 (weekly urticaria activity score) compared to placebo across multiple dose groups, including improvements in quality of life and angioedema measurements, and demonstrated a favorable safety profile. The data presented today further support these results by demonstrating improvements in AAS7 (weekly angioedema activity score) and additional measures of angioedema control over the 52 week treatment period. AAS7 measures the frequency and intensity of angioedema episodes, where higher scores indicate increased angioedema activity. 'The majority of patients with severe CSU suffer with angioedema, which is often extremely painful and causes disfigurement, dramatically impacting quality of life,' said Diane C. Young, MD, Senior Vice President and Chief Medical Officer of Celldex Therapeutics. 'Consistent with previously reported clinical outcomes, we observed rapid, profound angioedema relief with barzolvolimab treatment and this benefit continued to improve over 52 weeks of therapy for patients. These data add to the unprecedented 76 week efficacy and safety data we presented yesterday at EAACI and continue to support barzolvolimab's potential to redefine the treatment landscape and meet the goals of CSU therapy—rapid, profound, durable complete response and improved quality of life across a broad patient population.' Summary of Key Findings: Patients on study had severe CSU. Over 70% of patients had a weekly urticaria activity score (UAS7) greater than 28 at baseline and reported very high rates of angioedema at baseline. Barzolvolimab demonstrated rapid, robust and durable improvements in angioedema symptoms over the treatment period. At Week 52, an 86% mean reduction from baseline was reported for 150 mg Q4W arm and an 82% reduction was reported for the 300 mg Q8W. Up to 77% of patients treated with barzolvolimab who had angioedema at baseline were angioedema free (AAS7=0) at Week 52. Patients treated with barzolvolimab were angioedema free up to 72% of the time over the 52 week treatment period. Up to 87% of patients reported clinically meaningful improvement ( > 8 point) in AAS7 at Week 52. 1 DermNet . About Barzolvolimab Barzolvolimab is a humanized monoclonal antibody that binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity. KIT is expressed in a variety of cells, including mast cells, which mediate inflammatory responses such as hypersensitivity and allergic reactions. KIT signaling controls the differentiation, tissue recruitment, survival and activity of mast cells. In certain inflammatory diseases, such as chronic urticaria, mast cell activation plays a central role in the onset and progression of the disease. Barzolvolimab is currently being studied in chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU), prurigo nodularis (PN), eosinophilic esophagitis (EOE) and atopic dermatitis (AD), with additional indications planned for the future. About the Phase 2 CSU Study The randomized, double-blind, placebo-controlled, parallel group Phase 2 study evaluated the efficacy and safety profile of multiple dose regimens of barzolvolimab in patients with CSU who remain symptomatic despite antihistamine therapy, to determine the optimal dosing strategy. 208 patients were randomly assigned on a 1:1:1:1 ratio to receive subcutaneous injections of barzolvolimab at 75 mg every 4 weeks, 150 mg every 4 weeks, 300 mg every 8 weeks or placebo during a 16-week placebo-controlled treatment period. After 16 weeks, patients then entered a 36-week active treatment period, in which patients receiving placebo or the 75 mg dose were randomized to receive barzolvolimab 150 mg every 4 weeks or 300 mg every 8 weeks; patients already randomized to the 150 mg and 300 mg treatment arms remained on the same regimen as during the placebo-controlled treatment period. After 52 weeks, patients entered a follow-up period for an additional 24 weeks. Barzolvolimab achieved the primary efficacy endpoint of the study—a statistically significant mean change from baseline to Week 12 in UAS7 (weekly urticaria activity score) compared to placebo at all dose levels. For additional information on this trial (NCT05368285), please visit About the Phase 3 Program Celldex is currently conducting a global Phase 3 Program for barzolvolimab in CSU, consisting of two Phase 3 trials (EMBARQ-CSU1; NCT06445023 and EMBARQ-CSU2; NCT06455202) designed to establish the efficacy and safety of barzolvolimab in adult patients with CSU who remain symptomatic despite H1 antihistamine treatment. The studies also include patients who remain symptomatic after treatment with biologics. Enrollment is underway. About Chronic Spontaneous Urticaria (CSU) CSU is characterized by the occurrence of hives or wheals for 6 weeks or longer without identifiable specific triggers or causes. The activation of the mast cells in the skin (release of histamines, leukotrienes, chemokines) results in episodes of itchy hives, swelling and inflammation of the skin that can go on for years or even decades. Current therapies provide symptomatic relief only in some patients. About Celldex Celldex is pioneering new horizons in immunology to deliver life-changing therapies. We are relentless in our pursuit of novel antibody-based treatments that engage the human immune system and directly affect critical pathways to improve the lives of patients with allergic, inflammatory and autoimmune disorders. Visit Forward Looking Statement This release contains 'forward-looking statements' made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as 'believes,' 'expects,' 'anticipates,' 'intends,' 'will,' 'may,' 'should,' or similar expressions. These forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of Company drug candidates, including barzolvolimab (also referred to as CDX-0159), in current or future indications; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the availability, cost, delivery and quality of clinical materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company's programs to continue to develop; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; our ability to continue to obtain capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; and other factors listed under 'Risk Factors' in our annual report on Form 10-K and quarterly reports on Form 10-Q. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise. Company ContactSarah CavanaughSenior Vice President, Corporate Affairs & Administration(508) 864-8337 [email protected]
Yahoo
09-05-2025
- Business
- Yahoo
Celldex Therapeutics, Inc. (CLDX): Among the Best Cancer Stocks to Invest in for Long-Term Gain
We recently published a list of . In this article, we are going to take a look at where Celldex Therapeutics, Inc. (NASDAQ:CLDX) stands against other best cancer stocks to invest in for long-term gain. After cardiovascular disease, cancer is the second most common cause of mortality worldwide. In January 2023, the American Cancer Society released figures indicating that by the end of 2023 alone, there would be approximately 1,958,310 cancer patients in the United States. Compared to 2010, this is a 28% increase. In the United States, it was anticipated that over 600,000 people would die from cancer in 2024, and over 2 million new cases would be diagnosed. Cancer treatment expenses are rising in tandem with the growing number of cancer sufferers. In 2020, cancer treatment in the United States cost about $200 billion, but by 2030, the total cost is expected to surpass $245 billion. Over the past 20 years, global funding for cancer research has increased dramatically, according to the 'Oncology Pharmaceuticals Market 2024' report. Between 2017 and 2022, the FDA authorized 161 new cancer medicines, demonstrating the rapid advancement of cancer treatment. According to these figures, oncology is among the most extensive fields within the field of biological sciences. From diagnosis to therapy, the whole cancer care process is covered by the oncology industry. Global biotech and pharmaceutical businesses are always working to create more potent cancer treatments. Fortune Business Insights predicts that the scope of this undertaking will only grow shortly. In 2023, the global market for cancer medications was estimated to be worth $201.75 billion. It is projected to increase from $220.80 billion in 2024 to $518.25 billion by 2032 at a compound annual growth rate (CAGR) of 11.3%. The development of tailored immunotherapies for cancer treatment and the rising incidence of cancer worldwide are some of the main reasons propelling the market for oncology medications. Investing in businesses related to oncology is a profitable venture due to this growth rate. The global market for oncology medications is dominated by North America. In 2023, its market share was 45.92%. The market for precision oncology exhibits comparable patterns. Precision oncology, according to the National Institutes of Health (NIH), is a type of treatment in which doctors select therapies while taking into account each patient's unique tumor's DNA signature. In 2024, the global precision oncology market was estimated to be worth $115.8 billion, according to data from Grand View Research. A compound annual growth rate (CAGR) of 8.05% is projected between 2025 and 2030. The rising need for diagnostic products, technical advancements, avoiding specific medication resistance, and the growing reduction of adverse effects of cancer treatments are all factors contributing to this growth. AI usage is rapidly growing in the field of cancer. A study by Mordor Intelligence projects that the size of the AI in the cancer industry will be approximately $1.98 billion in 2025 and will grow to approximately $9.04 billion by 2030. This represents growth from 2025 to 2030 at a CAGR of 35.51%. AI's growing use in the diagnosis, analysis, and treatment of complicated oncology datasets is simplifying the process and lessening the strain on medical staff and hospital infrastructure. Although North America is the largest market for AI in oncology, the Asia-Pacific area is the one with the quickest rate of growth. Given this, we will take a look at some of the best cancer stocks for long term gains. In our methodology, we first filtered cancer stocks based on their 5-year average returns. From this pool, we identified the top 10 stocks with the highest number of hedge fund holders as of Q4 2024, according to the Insider Monkey database. In cases where multiple stocks had the same number of hedge fund holders, we used their 5-year total returns as a tiebreaker, ranking the stock with the higher return above the others. Why are we interested in the stocks that hedge funds pile into? The reason is simple: our research has shown that we can outperform the market by imitating the top stock picks of the best hedge funds. Our quarterly newsletter's strategy selects 14 small-cap and large-cap stocks every quarter and has returned 373.4% since May 2014, beating its benchmark by 218 percentage points (see more details here). A closeup of a scientist conducting research in a clinical lab setting. Number of Hedge Fund Holders: 29 Total 5-Year Return: 691.21% Celldex Therapeutics, Inc. (NASDAQ:CLDX) is a biopharmaceutical company focused on developing innovative antibody-based therapies for cancer and inflammatory diseases. It creates monoclonal and bispecific antibodies to boost the immune system's response. Celldex Therapeutics, Inc. (NASDAQ:CLDX) is advancing its lead candidate, barzolvolimab, which is a first-in-class humanized monoclonal antibody targeting KIT, aimed at treating mast cell-driven disorders like chronic urticaria and eosinophilic esophagitis (EoE). Barzolvolimab is currently in Phase 3 trials for chronic spontaneous urticaria (CSU), with Phase 3 trials for chronic inducible urticaria (CIndU) expected in 2025. It's also in Phase 2 for EoE, prurigo nodularis (PN), and atopic dermatitis (AD). Another pipeline asset, CDX-622, a bispecific antibody targeting SCF and TSLP, is in Phase 1 for inflammatory conditions. While the company is currently focused on inflammation, its antibody platform still holds oncology potential. Financially, Celldex Therapeutics, Inc. (NASDAQ:CLDX) reported $7 million in full-year 2024 revenue, flat year-over-year, with Q4 revenue at $1.2 million, down from $4.1 million due to fewer services provided to Rockefeller University. Their R&D expenses rose to $163.6 million in 2024, which reflected deeper investment in clinical programs. The net loss was $157.9 million, which was up from $141.4 million in 2023, consistent with late-stage biotech spending trends. Celldex Therapeutics, Inc. (NASDAQ:CLDX) also maintains a strong balance sheet with $725.3 million in cash and securities as of December 31, 2024—enough to fund operations through 2027. There is no reported debt, and Q4 cash burn was $32.5 million. The company's recent developments include the launch of the Phase 3 CIndU trial, pipeline expansion into atopic dermatitis, and the first-in-human trial for CDX-622. Overall, CLDX ranks 8th on our list of best cancer stocks to invest in for long-term gain. While we acknowledge the potential of cancer companies, our conviction lies in the belief that some AI stocks hold greater promise for delivering higher returns, and doing so within a shorter time frame. There is an AI stock that went up since the beginning of 2025, while popular AI stocks lost around 25%. If you are looking for an AI stock that is more promising than CLDX but that trades at less than 5 times its earnings, check out our report about this cheapest AI stock. READ NEXT: 20 Best AI Stocks To Buy Now and 30 Best Stocks to Buy Now According to Billionaires. Disclosure: None. This article is originally published at Insider Monkey. Sign in to access your portfolio
Yahoo
01-03-2025
- Business
- Yahoo
Celldex Therapeutics Full Year 2024 Earnings: Revenues Beat Expectations, EPS In Line
Net loss: US$157.9m (loss widened by 12% from FY 2023). US$2.45 loss per share. All figures shown in the chart above are for the trailing 12 month (TTM) period Revenue exceeded analyst estimates by 2.3%. Earnings per share (EPS) was mostly in line with analyst estimates. Looking ahead, revenue is forecast to grow 70% p.a. on average during the next 3 years, compared to a 20% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's shares are down 8.4% from a week ago. Be aware that Celldex Therapeutics is showing 2 warning signs in our investment analysis that you should know about... Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Sign in to access your portfolio
