Celldex reports Q2 2026 results as barzolvolimab Phase 3 enrollment finishes early
Celldex says its two pivotal CSU trials completed enrollment ahead of schedule, with topline results due in September or October 2026 ahead of a planned 2027 BLA filing.
Celldex Therapeutics reported second quarter 2026 financial results and a pipeline update on August 6, 2026. The company said enrollment in the global Phase 3 program for chronic spontaneous urticaria, made up of the EMBARQ-CSU1 and EMBARQ-CSU2 trials, finished six months ahead of guidance, with 1,939 patients enrolled across 43 countries and more than 500 sites, making it the largest program conducted in antihistamine refractory CSU.1 Celldex said it expects topline data from those two trials in September or October 2026, which would support a Biologics License Application filing planned for 2027.1
In cold urticaria and symptomatic dermographism, Celldex noted that it started a global Phase 3 study, EMBARQ-ColdU and -SD, in December 2025, which is now actively enrolling.1 In atopic dermatitis, the company said enrollment is complete in the Phase 2 study, with topline data expected to be presented in late 2026.1 Separately, Celldex reported that a Phase 2 study in prurigo nodularis, with topline data presented in July 2026, did not meet its primary or key secondary endpoints, and the company is discontinuing that study.1
On the bispecific antibody program, Celldex said Phase 1 results for CDX-622 showed rapid, profound, dose-dependent, and durable reductions in serum tryptase, and the drug was well tolerated across all study parts and dose levels with no dose-limiting toxicities or related serious adverse events.1 The company said it is running a Phase 1 proof-of-mechanism study of CDX-622 in adults with mild to moderate asthma, initiated in January 2026, and is advancing expansion into allergic rhinitis and food allergy based on recent data.1
On finances, Celldex reported cash, cash equivalents and marketable securities of $717.6 million as of June 30, 2026, up from $451.5 million at March 31, 2026, driven mainly by $323.8 million in net proceeds from an April 2026 public offering.1 The company said it believes this cash position is sufficient to fund planned operations through 2028.1
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