barzolvolimab (CDX-0159) / Celldex - LARVOL DELTA

Chronic Spontaneous Urticaria in the Era of Targeted Therapy: From Pathogenic Mechanisms to Precision Medicine. (PubMed, Pharmaceutics) - "Advances in understanding CSU pathogenesis have enabled the development of targeted therapies that may improve disease control. Predictive biomarkers and endotypic characterization may support the future development of more personalized therapeutic strategies; however, clinically validated biomarkers for treatment selection remain limited, and prospective validation of biomarker-guided approaches is still needed."

Journal • Review • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Immunology • Inflammation • Urticaria

Celldex Announces Positive Results from Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 Studies of Barzolvolimab Which Met Primary and All Key Secondary Endpoints (GlobeNewswire) - "The Company intends to present the EMBARQ-CSU data at an upcoming medical meeting and plans to submit a Biologics License Application (BLA) to the FDA in 2027...Efficacy was sustained or deepened from weeks 12 to 24 across primary and all key secondary endpoints...Key Secondary Endpoints: All key secondary endpoints in both EMBARQ-CSU trials were met at Week 12 with high statistical significance and were clinically meaningful...Significantly more patients achieved Complete Response (UAS7=0) with both barzolvolimab doses vs. placebo at Weeks 12 and 24...A higher proportion of patients achieved Complete Response (UAS7=0) vs placebo at Week 12 in the sub-population of patients with CSU refractory to omalizumab....Barzolvolimab was well-tolerated and demonstrated a favorable safety profile consistent with prior experience through the end of the placebo controlled period at Week 24."

FDA filing • P3 data: top line • Chronic Spontaneous Urticaria • Immunology

Targeted Therapy for Antihistamine-Refractory Chronic Spontaneous Urticaria: A Critical Narrative Review and an Evidence-Graded Approach to Agent Selection. (PubMed, Antibodies (Basel)) - "Between February 2024 and September 2025 the landscape changed: dupilumab (anti-IL-4Rα) and the first oral Bruton tyrosine kinase (BTK) inhibitor, remibrutinib, were approved for CSU; omalizumab biosimilars reached the market; the higher-affinity anti-IgE antibody ligelizumab was discontinued; and the investigational anti-KIT antibody barzolvolimab advanced to phase 3-creating new therapeutic opportunities for non-responders while leaving the choice among these second-line options unresolved by current guidelines. Current evidence appears to support omalizumab as first-line, with mechanism-guided second-line choices conditioned on endotype, comorbidity, prior biologic exposure and safety. The complexity of CSU and the incomplete response to currently available therapies support a patient-tailored approach to treatment selection."

Journal • Review • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Beyond Omalizumab: Emerging Biologic and Small Molecule Therapies in Chronic Spontaneous Urticaria. (PubMed, Clin Exp Allergy) - "The oral BTK inhibitor remibrutinib is now licensed for adults in the United States and European Union; Dupilumab, approved from 12 years of age in 2025, was extended to children aged 2-11 years in 2026 on basis of extrapolated efficacy supported by paediatric pharmacokinetic and safety data. Barzolvolimab has completed Phase 3 enrolment of 1939 adults, briquilimab, EVO756, EP262 and rilzabrutinib are advancing in adults and ligelizumab failed to demonstrate superiority over omalizumab...Adults dominate the trial populations; adolescents are enrolled as underpowered subgroups; dedicated paediatric evidence is essentially confined to dupilumab; and older adults-in whom comorbidity, polypharmacy and the cardiovascular and malignancy signals of JAK inhibition matter most-are almost never analyzed separately. Head-to-head and sequencing trials, endotype-stratified patient selection, age-inclusive trial design and long-term safety data are the immediate priorities if..."

Journal • Review • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Immunology • Oncology • Pediatrics • Urticaria • IL13 • IL4

Barzolvolimab Treatment Leads to Substantial Improvement in Patient-Reported Outcomes and Demonstrates Corresponding Benefits in Quality of Life in Chronic Inducible Urticaria (EADV 2026) - No abstract available

Clinical • HEOR • Patient reported outcomes • Dermatology • Immunology • Urticaria

Treatment with Barzolvolimab Improves Urticaria Control and Quality of Life in Patients with Chronic Inducible Urticaria (EADV 2026) - No abstract available

Clinical • HEOR • Dermatology • Immunology • Urticaria

Barzolvolimab Treatment Leads to Achievement of Both Complete Response As Well As No Impact of Disease on Quality of Life in Chronic Spontaneous Urticaria (EADV 2026) - No abstract available

Clinical • HEOR • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

A Phase 3 Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study of Barzolvolimab in Participants With Cold Urticaria and Symptomatic Dermographism: Trial-In-Progress (EADV 2026) - No abstract available

Clinical • P3 data • Dermatology • Immunology • Urticaria

Prolonged and Improved Quality of Life Off Treatment in Patients With Chronic Spontaneous Urticaria Treated With Barzolvolimab (EADV 2026) - No abstract available

Clinical • HEOR • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Barzolvolimab Improves Angioedema and Demonstrates Corresponding Benefits in Quality of Life in Chronic Spontaneous Urticaria (ACAAI 2026) - No abstract available

HEOR • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Barzolvolimab blocks SCF-enhanced IgE activation without inducing apoptosis in KIT-D816V mast cells. (PubMed, J Allergy Clin Immunol) - "Our findings demonstrate a functional dissociation between KIT-dependent survival and activation pathways in mutated MCs. While barzolvolimab does not reduce the viability of KIT-mutated MCs, it effectively suppresses SCF-dependent amplification of IgE-mediated activation, supporting its potential as a therapeutic option for symptomatic patients harboring KIT mutations, particularly for the control of mediator-related symptoms."

Journal • Tumor mutational burden • Oncology • CD63 • TMB

Emerging and Newly Approved Therapies for Antihistamine-Refractory Chronic Spontaneous Urticaria: A Narrative Review. (PubMed, Diseases) - "This narrative review outlines the guideline framework that still anchors CSU care, appraises the pivotal efficacy and safety data for omalizumab, dupilumab, remibrutinib, and barzolvolimab, and considers how these mechanistically distinct agents might be positioned and sequenced. The widening choice makes individualized, mechanism-informed treatment a realistic goal, but it also sharpens unresolved questions about patient selection, optimal treatment duration in a naturally remitting disease, and the long-term safety of newer oral and mast cell-depleting approaches."

Journal • Review • Cardiovascular • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria • IL4R

Barzolvolimab: Targeting the effector cell in chronic spontaneous urticaria. (PubMed, J Allergy Clin Immunol) - No abstract available

Journal • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Barzolvolimab - KIT Inhibitor Program...The Phase 3 program consists of two trials-EMBARQ-CSU1 and EMBARQ-CSU2. (The Manila Times) - "Topline data are anticipated in September/October 2026, supporting a planned BLA filing in 2027."

FDA filing • P3 data: top line • Chronic Spontaneous Urticaria • Immunology

This randomized, double-blind, placebo-controlled, parallel group study is evaluating the efficacy and safety profile of barzolvolimab in patients with moderate to severe AD. (The Manila Times) - "Topline data from this study are expected to be presented in late 2026."

P2 data • Atopic Dermatitis • Immunology

Barzolvolimab, a humanized monoclonal antibody with a completely novel mechanism of action that uniquely targets the mast cell, is being studied across multiple indications (GlobeNewswire) - "Phase 3 CSU topline data expected in Sept/Oct 2026; Phase 3 SD and ColdU Enrollment On Track; Phase 2 topline data in AD in late 2026."

Enrollment status • P2 data • P3 data: top line • Atopic Dermatitis • Chronic Spontaneous Urticaria • Urticaria

Celldex Reports Results from Phase 2 Study of Barzolvolimab in Prurigo Nodularis (GlobeNewswire) - "The primary endpoint of the study, the proportion of patients who achieve a four point or greater improvement in WI-NRS (Worst Itch Numeric Rating Scale) from baseline to Week 12, and key secondary endpoints were not met....Based on these results, Celldex is discontinuing the Phase 2 study in PN. Consistent with previously reported studies, barzolvolimab demonstrated a favorable safety and tolerability profile....The study did not meet primary or key secondary endpoints at Week 12 at either dose level evaluated. Percentage of patients with at least 4 point improvement in WI-NRS did not differentiate from placebo. Percentage of patients with IGA-CPNG-S 0/1...did not differentiate from placebo. No improvement observed with longer treatment (Week 24)."

P2 data • Trial termination • Immunology • Prurigo Nodularis

Celldex Presents Long-Term Barzolvolimab Results Demonstrating Sustained Off-Treatment Improvement in Angioedema in Patients with CSU at the European Academy of Allergy and Clinical Immunology Annual Meeting (GlobeNewswire) - "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."

P2 data • Chronic Spontaneous Urticaria • Immunology

Celldex Announces Multiple Upcoming Presentations from Leading Mast Cell Targeting Pipeline at the Upcoming 2026 European Academy of Allergy and Clinical Immunology Annual Congress (GlobeNewswire) - "Results supporting Celldex’s leadership and barzolvolimab’s first-in-class, best-in-disease profile in chronic spontaneous urticaria (CSU) and cold urticaria (ColdU) will be presented in two flash talks. New, first-in-human results from the Phase 1 trial of the novel bispecific CDX-622 in healthy volunteers will be presented in a late-breaking poster session, highlighting the potential for bispecific targeting of soluble stem cell factor (SCF) and thymic stromal lymphopoietin (TSLP) to inhibit KIT signaling in mast cells."

Clinical data • Late-breaking abstract • Chronic Spontaneous Urticaria • Inflammation • Urticaria

Long-term Barzolvolimab Treatment Results in Sustained Off-treatment Improvement in Angioedema in Patients with CSU Refractory to Antihistamines (EAACI 2026) - P2 | "We previously reported statistically significant and clinically meaningful improvements in weekly angioedema activity score (AAS7) during treatment with barzolvolimab, an anti-KIT monoclonal antibody that depletes MCs, in patients with antihistamine refractory CSU, including patients who previously received omalizumab. Conclusion Barzolvolimab treatment demonstrated sustained off-treatment improvement in angioedema in patients with antihistamine refractory CSU and angioedema at baseline. These results combined with a favorable safety profile support the ongoing Phase 3 studies in CSU."

Clinical • Dermatitis • Immunology

Psychometric Validation of the Worst Itch Numeric Rating Scale (WI-NRS) as a Patient-Reported Outcome (PRO) in Cold Urticaria: Data from a Clinical Trial of Barzolvolimab (EAACI 2026) - P2 | "Conclusion The psychometric performance of WI-NRS was robust. These analyses support the fit-for-purpose status of the weekly average WI-NRS score as a patient-centric secondary endpoint for use in conjunction with provocation-based endpoints."

Clinical • Patient reported outcomes • Dermatitis • Immunology

Long-term Efficacy and Safety Extension (LTE) Study of Barzolvolimab in Participants With Chronic Spontaneous Urticaria (clinicaltrials.gov) - P3 | N=1370 | Enrolling by invitation | Sponsor: Celldex Therapeutics | Recruiting ➔ Enrolling by invitation

Enrollment status • Chronic Spontaneous Urticaria • Dermatology • Immunology • Urticaria

Differential susceptibility of hair colour changes after barzolvolimab. (PubMed, J Eur Acad Dermatol Venereol) - No abstract available

Journal • Dermatology • Immunology • Urticaria

Barzolvolimab depletes cutaneous mast cells and mast cell–driven itch pathways in prurigo nodularis (SID 2026) - "A single dose of Barzolvolimab induces profound local depletion of cutaneous mast cells and downregulation of mast cell–driven itch mediators in PN. These findings provide direct cutaneous evidence supporting mast cells as key drivers of pruritus in PN and highlight KIT inhibition as a targeted therapeutic strategy."

Immunology • Prurigo Nodularis • Pruritus • POSTN

Recent Program Highlights (Celldex Press Release) - "The Phase 3 program consists of two trials—EMBARQ-CSU1 and EMBARQ-CSU2. 1,939 patients were enrolled...Topline data are anticipated in Q4 2026, supporting a planned BLA filing in 2027."

FDA filing • P3 data: top line • Chronic Spontaneous Urticaria