Latest news with #barzolvolimab
Yahoo
2 days ago
- Health
- Yahoo
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 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. 1DermNet. About BarzolvolimabBarzolvolimab 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 StudyThe 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 ProgramCelldex 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) 864-8337scavanaugh@ Patrick TillMeru Advisors(484) 788-8560ptill@ in to access your portfolio
Globe and Mail
12-05-2025
- Business
- Globe and Mail
2 'Strong Buy' Biotech Growth Stocks With Over 200% Upside Potential
Growth stocks, particularly those in the biotech sector, can be lucrative long-term investments. The biotech sector often develops cutting-edge treatments (like gene therapy, immuno-oncology, and obesity drugs) that have the potential to redefine the healthcare industry. Shares of companies in the clinical stage can skyrocket in a short period of time following the success of a clinical trial or FDA approval. However, these stocks also carry high risk, as their performance is heavily reliant on innovation, clinical trial success, and regulatory approval. Here are two 'Strong Buy'-rated biotech growth stocks with potential upside of more than 200% that Wall Street believes are worth the risk. Growth Stock #1: Celldex Therapeutics With a market cap of $1.2 billion, Celldex Therapeutics (CLDX) is a clinical-stage biopharmaceutical company focused on developing monoclonal and bispecific antibody therapies to treat severe inflammatory, allergic, autoimmune, and other life-threatening diseases. The company has several promising candidates in its pipeline, the most advanced of which is barzolvolimab. Celldex stock has fallen 21.3% so far this year. Nonetheless, analysts believe the stock has the potential to rally as much as 213% over the next 12 months, based on the average price target of $62.38. Celldex's lead candidate is barzolvolimab, a monoclonal antibody that targets KIT, a receptor tyrosine kinase found in a variety of inflammatory diseases. The drug is currently undergoing Phase 3 clinical trials for chronic spontaneous urticaria (CSU). This year, the drug will be tested in a separate Phase 3 trial for chronic inducible urticaria (CIndU). It is currently being tested in phase 2 clinical trials for prurigo nodularis (PN), eosinophilic esophagitis, and atopic dermatitis. The biotech's other notable candidate is CDX-622, which is Celldex's first bispecific antibody candidate targeting inflammatory pathways, and is currently in a Phase 1 trial. The company had $673.3 million in cash, cash equivalents, and marketable securities at the end of the first quarter, which it believes will be sufficient to fund its operations until 2027. As a clinical-stage company, the company reported a net loss of $0.81 per share, which exceeded analysts' expectations for a $0.74 loss per share in Q1. The increased net loss was primarily caused by higher research and development (R&D) costs associated with the advancement of its lead candidate, barzolvolimab. Celldex's lead candidate aims to treat a variety of inflammatory conditions. While the company faces challenges, including clinical and regulatory hurdles, its strong cash position and diverse pipeline position it for future growth, which is probably why analysts are so bullish about the stock. Recently, Morgan Stanley and TD Cowen analysts reiterated their 'Buy' ratings on the stock, citing its strong financial position and promising clinical developments. Overall, on Wall Street, Celldex stock is a ' Strong Buy.' Out of the 15 analysts covering CLDX, 13 rate it a 'Strong Buy,' and two rate it a 'Hold.' The average target price of $62.38 suggests the stock has an upside potential of 213% above current levels. The high target price of $90 implies a potential upside of 351% over the next 12 months. Growth Stock #2: Viking Therapeutics Valued at $3.09 billion, Viking Therapeutics (VKTX) is a clinical-stage biopharmaceutical company that develops therapies for metabolic and endocrine disorders. Viking stock has been highly volatile. After a massive 116% gain last year, the stock has fallen 29.3% year-to-date, compared to the broader market's 0.9% pullback. Viking's most notable program is VK2735 for obesity, a dual GLP-1/GIP receptor agonist designed to mimic hormones that regulate appetite and blood sugar levels. The drug is being developed in both injectable and oral forms to address the growing obesity treatment market. VK2735 demonstrated positive results in Phase 2 trials, and Phase 3 trials are scheduled for the second quarter of 2025. Furthermore, to support the commercialization of VK2735, Viking has signed a manufacturing agreement with CordenPharma. This agreement secures the supply of both the active pharmaceutical ingredient and the finished product, addressing concerns about ramping up production if and when the drug is approved. Its pipeline also includes VK2809, an orally available thyroid hormone receptor beta agonist that is currently in Phase 2b clinical trials for the treatment of non-alcoholic steatohepatitis (NASH) and non-alcoholic fatty liver disease. Additionally, VK0214, an investigational drug for X-linked adrenoleukodystrophy (X-ALD), is in Phase 1b clinical trials. In the obesity market, Viking faces stiff competition from two pharmaceutical behemoths, Novo Nordisk (NVO) and Eli Lilly (LLY). These companies have established obesity treatments on the market. However, Viking's candidate VK2735 offers a potential advantage with its oral formulation, which may appeal to patients who prefer pills over injections. According to a MarketWatch report, William Blair analysts believe that this agreement could result in 6.5 million patient doses per year, potentially generating $39 billion in revenue. Analysts also believe that its financial stability supports a strong pipeline with numerous growth opportunities. At the end of the most recent quarter, the company had $852 million in cash, cash equivalents, and short-term investments to fund its strong pipeline. Viking Therapeutics is currently in the clinical stage, which means that it does not yet generate revenue from product sales. In the first quarter of 2025, the company reported a net loss of $0.41 per share, which was wider than the previous year's loss of $0.26 per share and the estimated loss of $0.31 per share. The increase in net losses was due to a $17.3 million increase in R&D expenses during the quarter. Overall, on Wall Street, Viking stock is a ' Strong Buy.' Of the 18 analysts covering the stock, 16 rate it a 'Strong Buy,' and two say it is a 'Hold.' The average target price of $90.12 suggests the stock has an upside potential of 213.5% above current levels. VKTX's high target price of $125 implies a potential upside of 334.8% over the next 12 months. Viking stock more than doubled in 2024, driven by positive clinical outcomes, so these upsides don't seem unattainable.
