Tillkännagivande • Mar 28

Celldex Therapeutics, Inc. Presents Positive Data From Phase 2 Chronic Spontaneous Urticaria And Phase 2 Cold Urticaria And Symptomatic Dermographism Studies Demonstrating Rapid, Profound And Durable Improvements In Patient Quality Of Life At AAD 2026

Celldex Therapeutics, Inc. presented additional positive data from the completed Phase 2 clinical trials of barzolvolimab in chronic spontaneous urticaria (CSU) and cold urticaria (ColdU) and symptomatic dermographism (SD) demonstrating profound improvements in patient quality of life (QoL) across all measured domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. Barzolvolimab is a humanized monoclonal antibody with a completely novel mechanism of action that uniquely targets the root cause of CSU, ColdU and SD—the mast cell. The data were presented at the 2026 Americal Academy of Dermatology (AAD) Annual Meeting being held March 27 – 31, 2026 in Denver, CO. Posters are available on the Celldex website. The Dermatology Life Quality Index (DLQI) measures impact of skin disease on quality of life, with a score of 0/1 indicating no effect of the disease on a patient’s life. As previously reported in the Phase 2 CSU study, up to 51% of patients on study experienced symptom free complete response (UAS7=0; no itch/no hives) at 12 weeks, which continued to deepen over 52 weeks of active therapy to up to 71% of patients. This profound clinical benefit continued even after patients were off therapy—up to 41% of patients reported complete response seven months after receiving their last dose of barzolvolimab. In the post hoc analysis presented at AAD, the impact of disease on QoL for the subset of patients who received 52 weeks of barzolvolimab therapy (150 mg every four weeks or 300 mg every eight weeks) and completed treatment with at least well controlled disease (UAS7<6) at Week 52 and had DLQI data through Week 76 was explored. The vast majority of patients included in this analysis had substantial disease burden at baseline (68% had both severe disease and angioedema) and patients had CSU for a long time (6 years, mean). Patients reported that their CSU had a very large negative impact on their QoL (DLQI mean baseline score of 15.6). At Week 52, 94% of patients with well controlled disease at Week 52 also had a DLQI of 0/1, indicating their disease had no impact on their QoL. Barzolvolimab treatment led to prolonged, off-treatment enhanced QoL seven months after the last dose of barzolvolimab. At baseline, patients reported their CSU significantly impacted their QoL across all 6 DLQI domains (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment). Profound improvements were observed across all 6 domains at both Weeks 52 and 76. 76% of patients with well controlled disease at Week 52 also reported that the disease had small to no impact (DLQI score = 5) on their QoL at Week 76. The majority of patients with well controlled disease at Week 52 achieved DLQI domain scores of 0/1 (no impact on QoL) at Week 76. This sustained off-treatment improvement in QoL was observed despite barzolvolimab clearance and normalization of tryptase (a measure of mast cell burden), suggesting disease modification and supports barzolvolimab’s significant potential to become a transformative treatment option for patients suffering from CSU. As previously reported in the Phase 2 ColdU and SD study, up to 53% of patients with ColdU and 58% with SD achieved complete response (negative provocation test) at Week 12 (primary endpoint analysis) and up to 66% of patients with ColdU and 49% with SD achieved complete response at Week 20. Barzolvolimab treatment improved the QoL of patients with ColdU and SD throughout the 20-week treatment period. Mean DLQI improved from a very large effect of disease on QoL at baseline to a small effect of disease on QoL at Week 20. Benefits on QoL were rapid and apparent by the first DLQI measurement at Week 4 (300 mg every eight weeks). Barzolvolimab treatment increased the rate of achieving no impact of disease on QoL (DLQI of 0/1) at Week 20 by up to 3.1-fold in patients with ColdU and 4.0-fold in patients with SD vs placebo. Barzolvolimab treatment resulted in improvements across all six DLQI domains, indicating broad, beneficial effects on QoL. This Phase 2 study is the first large randomized, placebo-controlled study to demonstrate clinical benefit in patients with chronic inducible urticaria. CSU is an underdiagnosed disease of misery marked by spontaneous hives, unbearable itch, and unpredictable episodes of disfiguring swelling (angioedema) that causes substantial mental health burden, profound impact on quality of life and is associated with a 1.7-fold increase in all cause mortality at 5 years. Mast cell activation plays a central role in the onset and progression of CSU. While the goal of CSU treatment is the complete absence of symptoms, the vast majority of patients today, even those receiving the most advanced approved and available therapies, continue to suffer from itch, hives, swelling, sleep disruption, and unrelenting anxiety about when the next flare up will occur. In February, Celldex announced the completion of enrollment in the Company’s global Phase 3 program in CSU. The Program, which fully accrued six months ahead of guidance, consists of two trials—EMBARQ-CSU1 and EMBARQ-CSU2. 1,939 patients were enrolled—the largest program conducted in antihistamine refractory CSU, including patients with advanced therapy experienced/refractory CSU. The studies included 43 countries and over 500 sites. Topline data from the studies are expected in the fourth quarter of 2026. Chronic inducible urticaria (CIndU) is characterized by the occurrence of hives or wheals that have an attributable trigger associated with them. ColdU symptoms include itching, burning wheals/hives and angioedema when skin is exposed to cold temperatures. SD symptoms include the development of wheals in response to stroking, scratching or rubbing of the skin.

Tillkännagivande • Oct 27

Celldex Therapeutics, Inc. Announces Positive Results from its Phase 2 Clinical Trial of Barzolvolimab

Celldex Therapeutics, Inc. announced positive results from the Company’s Phase 2 clinical trial of barzolvolimab in two of the most common forms of chronic inducible urticaria (CIndU)—cold urticaria (ColdU) and symptomatic dermographism (SD). The study includes patients who remain symptomatic despite treatment with antihistamines. 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 were presented in a late breaking oral presentation at the American College of Allergy, Asthma & Immunology's Annual Scientific Meeting in Boston 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. Celldex previously reported that barzolvolimab achieved the primary efficacy endpoint of the study, a statistically significant difference between the percent of patients with a negative provocation test compared to placebo at Week 12 as assessed by the TempTest® in ColdU and the FricTest® in SD. The Company reported that all secondary endpoints in the study were also achieved at Week 12 and strongly support the primary endpoint results, including responder analyses, improvements in Critical Temperature and Critical Friction Thresholds (CFT and CFT), changes in WI-NRSprovo (itch associated with provocation test) and Urticaria Control Test. 196 patients with CIndU refractory to antihistamines were randomized to the study and 193 patients were included in the full analysis (mITT) and safety set (3 patients randomized to the study were not treated). 90% (n=173) of patients on study completed the study through 12 weeks (discontinuation rate of 8% barzolvolimab compared to 14% placebo). Demographics and baseline disease characteristics were well balanced across treatment groups. In cold urticaria, patients presented with a mean baseline critical temperature threshold of approximately 19°C or 66°F on the TempTest on initial provocation testing. In patients with symptomatic dermographism baseline FricTest thresholds were an average of 3.6 out of 4 pins. UCT scores at baseline reflect poorly controlled disease. Patients experienced rapid disease improvement as early as two weeks (the first assessment) after receiving the initial dose of barzolvolimab as demonstrated by reductions in critical temperature and friction thresholds resulting in hives and rapid reduction in itch at the time of provocation testing (WI-NRSprovo). Barzolvolimab was well tolerated with a favorable safety profile consistent with prior studies. Most adverse events were grade 1 (mild). Through 12 weeks, the most common treatment emergent adverse events in barzolvolimab treated patients were hair color changes (13%; Grade 1, n=15 /Grade 2, n=2) and neutropenia (10%; Grade 1, n=7 /Grade 2, n=6), which are mechanism related (KIT) and expected to be reversible. The rate of infections was similar between barzolvolimab-treated patients and placebo with no association between neutropenia and infections. 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) and eosinophilic esophagitis (EOE) with additional indications planned for the future, including atopic dermatitis (AD). Phase 2 CIndU Study: This study is a randomized, double-blind, placebo-controlled, parallel group study evaluating the efficacy and safety profile of two dose regimens of barzolvolimab in patients with CIndU who remain symptomatic despite antihistamine therapy. 196 patients in 2 cohorts (differentiated by CIndU subtype) including 97 patients with ColdU and 99 patients with SD were randomly assigned on a 1:1:1 ratio to receive subcutaneous injections of barzolvolimab at 150 mg every 4 weeks, 300 mg every 8 weeks or placebo during a 20-week treatment phase. Patients then enter a follow-up phase for an additional 24 weeks. The study also includes an Open Label Extension that allows patients with symptoms during the follow-up phase (including patients who were on placebo during the 20-week treatment phase) to receive active study drug for an additional 20 weeks. The primary endpoint of the study is the percentage of patients with a negative provocation test at Week 12 (using TempTest® for ColdU and FricTest® for SD). Secondary endpoints include safety and other assessments of clinical activity including CTT (critical temperature threshold), CFT (critical friction threshold) and WI-NRSprovo (worst itch numeric rating scale associated with provocation testing). CIndU is characterized by the occurrence of hives or wheals that have an attributable trigger associated with them. ColdU symptoms include itching, burning wheals/hives and angioedema when skin is exposed to cold temperatures. SD symptoms include the development of wheals in response to stroking, scratching or rubbing of the skin. Approximately 0.5% of the total population suffers from chronic inducible urticarias. For these diseases, mast cell activation leading to release of soluble mediators is thought to be the driving mechanism leading to the wheals and other symptoms. There are currently no approved therapies for chronic inducible urticarias other than antihistamines and patients attempt to manage symptoms associated with their disease through avoidance of triggers.

Räntetäckningsgrad	n/a
Kontanter	US$451.46m
Eget kapital	US$456.23m
Summa skulder	US$55.03m
Totala tillgångar	US$511.25m

Uppgifter	Senast uppdaterad (UTC-tid)
Analys av företag	2026/06/28 06:44
Aktiekurs vid dagens slut	2026/06/26 00:00
Intäkter	2026/03/31
Årlig intjäning	2025/12/31

Paket	Uppgifter	Tidsram	Exempel US-källa
Företagets finansiella ställning	10 år	Resultaträkning Kassaflödesanalys Balansräkning	SEC Form 10-K SEC Form 10-Q
Analytikernas konsensusuppskattningar	+3 år	Prognos för finansiella poster Analytikernas prismål	Rapporter från analytiker Blue Matrix
Marknadspriser	30 år	Aktiekurser Utdelningar, splittar och åtgärder	ICE Marknadsdata SEC Form S-1
Ägarskap	10 år	Största aktieägare Insiderhandel	SEC Formulär 4 SEC Formulär 13D
Förvaltning	10 år	Ledningsgrupp Styrelse och verkställande direktörer	SEC Form 10-K SEC Form DEF 14A
Viktiga utvecklingstendenser	10 år	Företagsmeddelanden	SEC Formulär 8-K

Analytiker	Institution
Etzer Darout	Barclays
Edward Nash	Canaccord Genuity
Kristen Kluska	Cantor Fitzgerald & Co.

Celldex Therapeutics Balansräkning Hälsa

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We Think Celldex Therapeutics (NASDAQ:CLDX) Can Afford To Drive Business Growth

Recent updates

Celldex Therapeutics (CLDX) Stock Could Be 61% Below Fair Value After New Trial Data

Celldex Presents Long-Term Barzolvolimab Results Demonstrating Sustained Off-Treatment Improvement in Angioedema in Patients with CSU

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Celldex Therapeutics, Inc. Presents Positive Data From Phase 2 Chronic Spontaneous Urticaria And Phase 2 Cold Urticaria And Symptomatic Dermographism Studies Demonstrating Rapid, Profound And Durable Improvements In Patient Quality Of Life At AAD 2026

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Celldex Completes Enrollment in Global Phase 3 Studies (Embarq-Csu1 and Embarq-Csu2) of Barzolvolimab in Chronic Spontaneous Urticaria

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Chief Commercial Officer & Senior VP exercised options and sold US$490k worth of stock

Consensus revenue estimates fall by 19%

Third quarter 2025 earnings released: US$1.01 loss per share (vs US$0.64 loss in 3Q 2024)

Celldex Therapeutics, Inc. Announces Executive Changes

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Price target decreased by 7.9% to US$53.85

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Insufficient new directors

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Celldex Therapeutics, Inc., Annual General Meeting, Jun 05, 2025

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Now 20% overvalued

Consensus revenue estimates increase by 15%, EPS downgraded

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Full year 2024 earnings: EPS in line with analyst expectations despite revenue beat

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Founder recently bought US$308k worth of stock

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Consensus revenue estimates increase by 65%, EPS downgraded

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Second quarter 2024 earnings: EPS and revenues exceed analyst expectations

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Price target decreased by 7.6% to US$65.38

Senior VP & Chief Medical Officer recently sold US$1.6m worth of stock

Chief Commercial Officer & Senior VP notifies of intention to sell stock

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Senior VP recently sold US$341k worth of stock

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