CLDX

CDX-622 is a novel, bispecific antibody combining mast cell depletion and TSLP inhibition, two independent pathways contributing to multiple I&I diseases CDX-622 targets the soluble form of stem cell factor (SCF), depleting mast cells without measurably impacting other KIT functions Rapid, profound, dose-dependent, and durable reductions in serum tryptase observed Well-tolerated at all dose levels First company to demonstrate that neutralizing soluble SCF can selectively inhibit KIT signaling in mast cells HAMPTON, N.J., June 14, 2026 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) today presented positive results from the Phase 1 healthy participant study of CDX-622, a novel, bispecific antibody that targets soluble SCF and TSLP, at the European Academy of Allergy and Clinical Immunology (EAACI) Annual Meeting in Istanbul, Türkiye. Data demonstrated that CDX-622 induced rapid, durable, dose-dependent reductions in serum tryptase, indicative of mast cell depletion, and was well-tolerated at all dose levels. Building on Celldex’s leadership in mast cell science, the data also demonstrated that neutralizing soluble stem cell factor (SCF) enables the potential for meaningful mast cell inhibition and depletion without impacting other KIT-dependent functions. CDX-622 is currently being studied in a Phase 1b proof of mechanism study in mild to moderate asthma to assess the impact of dual neutralization of SCF and TSLP. “Celldex continues to drive groundbreaking science and is the first company to directly demonstrate that neutralizing soluble stem cell factor can selectively inhibit KIT signaling in mast cells, a historically challenging target,” said Tibor Keler, Ph.D., Co-founder, Executive Vice President and Chief Scientific Officer at Celldex. “Importantly, the approach of targeting soluble SCF provides a promising anchor mechanism enabling the development of a robust portfolio of bispecific candidates designed to overcome the heterogeneity inherent in the pathophysiology of many inflammatory diseases. Today’s results from CDX-622 highlight the potential of this approach and we look forward to initiating additional proof of concept studies in multiple indications where both mast cells and TSLP play a pathogenic role, focusing next on allergic rhinitis and food allergy.” “Mast cell targeting strategies are rapidly emerging as powerful therapeutic approaches in inflam...

Treatment with barzolvolimab resulted in rapid, significant, and durable improvements in angioedema in patients with moderate to severe CSU Seven months after the completion of dosing (Week 76), up to 64% of patients treated with barzolvolimab who had angioedema at baseline remained angioedema-free Barzolvolimab has potential to shift treatment goals from symptom control to disease modification Results continue to support ongoing Phase 3 trials of barzolvolimab in CSU; topline data expected in Q4 2026 HAMPTON, N.J., June 14, 2026 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) announced today the presentation of long-term results from the Phase 2 study of barzolvolimab in a flash talk session at the European Academy of Allergy and Clinical Immunology (EAACI) Annual Meeting in Istanbul, Türkiye. The data presented demonstrated that barzolvolimab treatment results in rapid, significant, and durable improvements in angioedema in patients with chronic spontaneous urticaria (CSU) refractory to antihistamines. These results were sustained off-treatment, seven months after completion of barzolvolimab dosing (Week 76). The data continue to demonstrate barzolvolimab’s potential to shift the goal of CSU treatment from symptom control to disease modification and further support the ongoing Phase 3 trials of barzolvolimab in CSU. “Angioedema plays a major role in the physical and mental health of the majority of people living with CSU, causing extremely painful swelling and disfigurement that dramatically impacts quality of life,” said Diane C. Young, MD, Senior Vice President and Chief Medical Officer of Celldex Therapeutics. “Barzolvolimab has consistently shown profound, lasting results including high rates of complete response, defined as complete absence of itch and hives, and dramatic improvements in quality of life and angioedema control through 52 weeks of therapy and now seven months after the last dose, demonstrating its potential for disease modification and the ability to change how CSU patients live their lives.” Angioedema occurs in 55% of people with CSU1 and patients report a mean of 7.7 angioedema episodes annually.2 Patients with CSU-related angioedema report significantly worse physical and mental health outcomes, lower health related quality of life, a higher percentage of anxiety and depression, along with significantly increased emergency room visits and...

HAMPTON, N.J. (AP) — HAMPTON, N.J. (AP) — Celldex Therapeutics Inc. (CLDX) on Thursday reported a loss of $78.7 million in its first quarter. On a per-share basis, the Hampton, New Jersey-based company said it had a loss of $1.18. The results fell short of Wall Street expectations. The average estimate of five analysts surveyed by Zacks Investment Research was for a loss of $1.10 per share. The biopharmaceutical company posted revenue of $15,000 in the period, also missing Street forecasts. Three analysts surveyed by Zacks expected $1.3 million. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on CLDX at https://www.zacks.com/ap/CLDX

Enrollment completed six months ahead of guidance in both barzolvolimab Phase 3 chronic spontaneous urticaria studies (EMBARQ-CSU 1 and 2); Topline data expected in Q4 26; BLA submission planned for 2027 Phase 3 barzolvolimab cold urticaria and symptomatic dermographism study (EMBARQ-ColdU and -SD) actively enrolling Phase 1 CDX-622 proof of mechanism study in asthma ongoing 2026 expected to deliver multiple key data readouts across the pipeline Raised $345 million in gross proceeds from a follow-on public offering, closed in April 2026 HAMPTON, N.J., May 07, 2026 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) today reported financial results for the first quarter ended March 31, 2026 and provided a corporate update. "We began the year with a significant milestone - the early completion of enrollment in our Phase 3 CSU studies - and we have continued to build on that momentum over the quarter,” said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex. “This spring, barzolvolimab was featured in five presentations at leading medical meetings, further reinforcing its potential as a first-in-class, best-in-disease therapy with the ability to transform the treatment landscape for patients in need of better options. This progress enabled the successful completion of a $345 million financing in early April, strengthening our balance sheet and supporting continued investments in our commercialization preparations and growing pipeline.” “As we look ahead, our focus remains on execution—driving strong enrollment across our Phase 3 study in ColdU and SD and advancing towards multiple important data readouts this year,” Mr. Marucci continued. “These include topline data from our Phase 3 barzolvolimab CSU studies, results from Phase 2 studies in prurigo nodularis and atopic dermatitis, and additional data from our novel bispecific program, CDX-622.” Recent Program Highlights Barzolvolimab - KIT Inhibitor Program Barzolvolimab is a humanized monoclonal antibody with a novel mechanism of action that targets mast cells by binding with high specificity to a unique part of the KIT receptor and potently inhibiting its activity. The KIT receptor is abundantly expressed by mast cells and critical for their function and survival. Mast cells are drivers of inflammatory responses such as hypersensitivity and allergic reactions and, in certain inflammatory dise...

Innoviva (INVA) came out with quarterly earnings of $0.44 per share, beating the Zacks Consensus Estimate of $0.43 per share. This compares to earnings of $0.25 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +3.53%. A quarter ago, it was expected that this biopharmaceutical company would post earnings of $0.34 per share when it actually produced earnings of $1.94, delivering a surprise of +470.59%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Innoviva, which belongs to the Zacks Large Cap Pharmaceuticals industry, posted revenues of $97.99 million for the quarter ended March 2026, missing the Zacks Consensus Estimate by 1.83%. This compares to year-ago revenues of $88.63 million. The company has topped consensus revenue estimates three times over the last four quarters. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Innoviva shares have added about 13.3% since the beginning of the year versus the S&P 500's gain of 6%. While Innoviva has outperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Innoviva was mixed. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #3 (Hold) for the stock. So, the shares are expected to perform in line with the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Bu...

HAMPTON, N.J. (AP) — HAMPTON, N.J. (AP) — Celldex Therapeutics Inc. (CLDX) on Wednesday reported a loss of $81.3 million in its fourth quarter. On a per-share basis, the Hampton, New Jersey-based company said it had a loss of $1.22. The results missed Wall Street expectations. The average estimate of six analysts surveyed by Zacks Investment Research was for a loss of $1 per share. The biopharmaceutical company posted revenue of $121,000 in the period, also falling short of Street forecasts. Three analysts surveyed by Zacks expected $1.4 million. For the year, the company reported a loss of $258.8 million, or $3.90 per share. Revenue was reported as $1.5 million. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on CLDX at https://www.zacks.com/ap/CLDX

Enrollment completed in both Phase 3 chronic spontaneous urticaria global registration studies (EMBARQ-CSU 1 and 2) six months ahead of guidance; Topline data expected in Q4 26; BLA submission planned for 2027 Phase 3 cold urticaria and symptomatic dermographism study (EMBARQ-ColdU and -SD) actively accruing Enrollment completed in Phase 2 prurigo nodularis and atopic dermatitis studies with topline data expected in 2026 Phase 1 CDX-622 Proof of Mechanism study in asthma initiated Company prepares for landmark year of clinical readouts in 2026 HAMPTON, N.J., Feb. 25, 2026 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) today reported financial results for the fourth quarter and year ended December 31, 2025 and provided a corporate update. "The enthusiasm for barzolvolimab continues to build, driven by unparalleled efficacy data across multiple indications,” said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex. “This is underscored by the completion of enrollment in our Phase 3 CSU studies six months ahead of guidance and strong interest from clinical trial sites in our recently initiated Phase 3 study in cold urticaria and symptomatic dermographism.” “During 2026, we are excited for multiple important data readouts across our pipeline, including topline data from our barzolvolimab Phase 3 studies in CSU, Phase 2 studies in prurigo nodularis and atopic dermatitis, and additional data from our novel bispecific program, CDX-622,” continued Mr. Marucci. “We continue to prepare for the planned BLA filing and commercialization of barzolvolimab in CSU, which has the potential to transform the treatment landscape and position Celldex as a pioneering immunology company—leading in mast cell biology and delivering groundbreaking therapies for patients who are waiting for better treatment options.” Recent Program Highlights Barzolvolimab - KIT Inhibitor Program Barzolvolimab is a humanized monoclonal antibody with a novel mechanism of action that targets mast cells by binding with high specificity to a unique part of the KIT receptor and potently inhibiting its activity. The KIT receptor is abundantly expressed by mast cells and critical for their function and survival. Mast cells are drivers of inflammatory responses such as hypersensitivity and allergic reactions and, in certain inflammatory diseases, such as chronic urticarias, mast cell activ...

HAMPTON, N.J. (AP) — HAMPTON, N.J. (AP) — Celldex Therapeutics Inc. (CLDX) on Monday reported a loss of $67 million in its third quarter. On a per-share basis, the Hampton, New Jersey-based company said it had a loss of $1.01. The results did not meet Wall Street expectations. The average estimate of six analysts surveyed by Zacks Investment Research was for a loss of 88 cents per share. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on CLDX at https://www.zacks.com/ap/CLDX

Strong execution and continued progress across pipeline Positive Phase 2 barzolvolimab data in Chronic Spontaneous Urticaria (CSU) demonstrating rapid, profound improvement in UCT7 scores with sustained disease control post treatment and strong efficacy regardless of baseline IgE levels Positive Phase 2 barzolvolimab data in Cold Urticaria (ColdU) and Symptomatic Dermographism (SD) demonstrating sustained efficacy and favorable safety profile at 20 weeks; first large, randomized, placebo-controlled study to demonstrate clinical benefit in these indications; Phase 3 study in ColdU and SD to initiate December 2025 Positive Phase 1 CDX-622 (SCF & TSLP) data; first stem cell factor neutralizing bispecific antibody to be studied in humans HAMPTON, N.J., Nov. 10, 2025 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) today reported financial results for the third quarter ended September 30, 2025 and provided a corporate update. "This quarter, Celldex continued to demonstrate our leadership in the field of mast cell biology, presenting exciting data across our pipeline programs,” said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex. “Barzolvolimab is the first in the field to demonstrate clinical benefit in a large, randomized, placebo-controlled study of cold urticaria and symptomatic dermographism, and we were also pleased to report additional endpoints from our Phase 2 CSU study and promising data from CDX-622, the first stem cell factor neutralizing bispecific antibody to be studied in humans, which we designed to also target TSLP.” “As we look to the close of 2025, we will continue to drive progress across our entire pipeline, expecting multiple data readouts throughout next year. Importantly, we are actively preparing for the potential commercialization of barzolvolimab and we are thrilled to announce today that Teri Lawver has joined Celldex as Senior Vice President, Chief Commercial Officer. Teri’s deep background in successfully launching multiple important immunology drugs will play a critical role in Celldex’s mission to deliver life-changing therapies to patients in need.” Recent Program Highlights Barzolvolimab - KIT Inhibitor Program Barzolvolimab is a humanized monoclonal antibody developed by Celldex that binds the KIT receptor with high specificity and potently inhibits its activity. The KIT receptor tyrosine kinase is express...

First large, randomized, placebo-controlled study to demonstrate clinical benefit in patients with Cold Urticaria (ColdU) and Symptomatic Dermographism (SD) All primary and secondary endpoints met with high statistical significance at 12 weeks and sustained through end of treatment period (20 weeks) Up to 78% of patients with ColdU and 58% of patients with SD obtained a partial or complete response at Week 20 Well tolerated through 20 weeks of dosing Phase 3 study in ColdU and SD to initiate in December 2025 HAMPTON, N.J., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) announced today new data demonstrating sustained efficacy and a well tolerated safety profile over a 20 week treatment period for barzolvolimab in two of the most common forms of chronic inducible urticaria (CIndU)—cold urticaria (ColdU) and symptomatic dermographism (SD). Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for mast cell function and survival. CIndU is characterized by the occurrence of hives or wheals that have an attributable trigger associated with them—exposure to cold temperatures in ColdU and scratching/rubbing of the skin in SD. Mast cell activation is known to be a critical driver in ColdU and SD. The data is being presented (presentation #R097) at the American College of Allergy, Asthma & Immunology's Annual Scientific Meeting (ACAAI) in Orlando, Florida (November 6-10, 2025) by Dr. Jonathan Bernstein, Professor of Clinical Medicine, Department of Internal Medicine, Division of Rheumatology, Allergy and Immunology, University of Cincinnati Medical Center and Partner, Bernstein Allergy Group and Clinical Research Center. “Barzolvolimab is the first drug to achieve success in a large, randomized, placebo-controlled study in chronic inducible urticaria—providing hope for patients who are impacted by severe itching and hives that dramatically impact all aspects of their lives despite constant vigilance to avoid disease triggers,” said Diane C. Young, MD, Senior Vice President and Chief Medical Officer of Celldex Therapeutics. “We previously reported that the study met all primary and secondary endpoints with high statistical significance and the data reported today continue to demonstrate that patients experience these clinically meani...

--Data from Phase 1 Study in healthy volunteers presented at CIA Biennial Symposium-- HAMPTON, N.J., Oct. 30, 2025 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) announced today positive data from the ongoing Phase 1 study of CDX-622, a novel bispecific antibody that targets two non-redundant, complementary pathways implicated in inflammation and fibrosis—mast cell depletion via stem cell factor (SCF) starvation and neutralization of the alarmin thymic stromal lymphopoietin (TSLP). CDX-622 was well tolerated, exhibited a good pharmacokinetic profile and induced rapid and sustained reductions in serum tryptase, indicative of mast cell inhibition and depletion. The data were presented by Diego Alvarado, PhD, Vice President of Research at Celldex, in an oral presentation at the CIA (Collegium Internationale Allergologicum) Biennial Symposium in Dubrovnik, Croatia. “Celldex continues to lead the field in therapeutic targeting of mast cells, presenting promising data today from the first stem cell factor neutralizing antibody to be studied in humans,” said Tibor Keler, PhD, Executive Vice President and Chief Scientific Officer of Celldex Therapeutics. “Combining this unique approach of mast cell depletion with the blockade of a validated and critical inflammation pathway driven by TSLP could potentially deliver profound clinical benefit for patients with inflammatory and fibrotic disorders where both mast cells and TSLP play a pathogenic role.” “The data presented today demonstrate that CDX-622 has a long half-life with no measurable immunogenicity observed to date—two critical hurdles for bispecific antibodies,” continued Dr. Keler. “We are very pleased with the safety profile and the sustained dose dependent reductions in serum tryptase we observed over a 12 week period following a single dose. Based on these data, we have progressed this study to the next phase of development and are now testing multiple ascending doses of CDX-622. We expect to complete this study next year and plan to initiate a Phase 1b proof of mechanism study in patients with mild to moderate asthma, where we will be able to assess the impact of dual neutralization of SCF and TSLP, which could support broad development in a number of clinical indications with significant unmet need.” Key presentation highlights: CDX-622 potently neutralizes TSLP and soluble SCF and leads to mast cell reduction...

Celldex Therapeutics experienced a share price increase of 19% over the last quarter, following significant developments in its clinical programs. Recently, the company announced promising results from a Phase 2 study of barzolvolimab, which showed effective mast cell depletion in eosinophilic esophagitis, albeit without clinical symptom improvement. Additionally, barzolvolimab demonstrated positive outcomes in treating chronic spontaneous urticaria. While Celldex's earnings faced challenges, with decreased revenue and increased losses, these clinical advancements may have counterbalanced broader market trends, contributing to the stock's overall upward movement during a period of generally positive market conditions. We've identified 1 weakness for Celldex Therapeutics that you should be aware of. We've found 18 US stocks that are forecast to pay a dividend yield of over 6% next year. See the full list for free. Over the past five years, Celldex Therapeutics' shares delivered a total return of 107.16%. Despite recent 1-year underperformance compared to the US market and Biotechs industry, this long-term appreciation underscores the impact of its clinical developments and strategic focus. In the past year, Celldex lagged behind the US market, which climbed 20.5%, and the Biotechs industry, which saw a decline of 6.3%. Recent clinical advancements, including promising outcomes for chronic spontaneous urticaria, might bolster revenue forecasts despite current unprofitability and expanded losses. However, the lack of symptom improvement in eosinophilic esophagitis could impact earnings expectations negatively. At the same time, the current share price of $24.30 signifies a notable discount compared to consensus analyst price targets of $56.25, indicating a potential upside if the company's pipeline efforts materialize effectively. This potential could attract attention despite recent challenges reflected in its financials and market positioning. Click here and access our complete financial health analysis report to understand the dynamics of Celldex Therapeutics. This 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 acco...