Celldex Finishes Enrollment Six Months Early in 1,939-Patient Phase 3 CSU Trials
Enrollment finished six months early in two Phase 3 chronic spontaneous urticaria studies with 1,939 patients across 43 countries; topline data expected in Q4 2026 and BLA submission targeted for 2027. Phase 2 prurigo nodularis and atopic dermatitis trials closed enrollment, with topline results due in summer and late 2026.
1. Q4 and Year-End Financial Results
Celldex reported fourth-quarter and full-year 2025 financial results and outlined strategic priorities for 2026, emphasizing advancement of its immunology pipeline without disclosing specific revenue or loss figures in this update.
2. Early Phase 3 CSU Enrollment Completion
The company completed enrollment in its global EMBARQ-CSU1 and EMBARQ-CSU2 trials six months ahead of schedule, enrolling 1,939 patients across 43 countries; topline efficacy and safety data are expected in Q4 2026 to support a BLA filing in 2027.
3. Ongoing Phase 2 and Phase 3 Studies
Enrollment finished in Phase 2 studies of prurigo nodularis and atopic dermatitis, with topline data slated for summer and late 2026 respectively; the Phase 3 EMBARQ-ColdU and symptomatic dermographism study continues active patient accrual.
4. Novel Bispecific Antibody CDX-622 Phase 1
The Phase 1 proof-of-mechanism trial for CDX-622, a bispecific antibody targeting SCF and TSLP, has completed enrollment in healthy volunteers to assess safety, pharmacokinetics and pharmacodynamics as part of the company’s novel bispecific platform development.