February 25, 2026
BIOINVEST NEWS: Celldex (CLDX)
Celldex Therapeutics – Celldex (CLDX) – The Barzo Train Has Left The Station – Phase III Trials Enroll Well Ahead Of Schedule
This morning, CLDX announced that the two Phase III trials for barzovolimab (“barzo”) in chronic spontaneous urticaria (CSU) have completed enrollment six months ahead of schedule. Top-line Phase III data are now expected to be released by the end of this year and BLA filing in 2027. Both us and the consensus were not expecting the see the Phase III data until late-2027 and a BLA in 2028. This is a major unexpected positive for a de-risked future blockbuster drug in only the first of many mast cell conditions. BUY
First Phase III Data in 2026 Now (Not 2027) – The studies over-enrolled by >100 patients driven by strong patient/clinician demand and the need for better treatment options in CSU. With consistent and excellent clinical execution, top line data is now due in Q4:26 followed by a potential BLA submission in 2027.
EMBARQ Studies – The Phase III EMBARQ program is evaluating barzo in adults with CSU who remain symptomatic despite H1 antihistamine treatment. EMBARQ is the largest program conducted in antihistamine refractory CSU, including patients with advanced therapy experienced/refractory CSU. As we’ve said ad nauseam, barzo’s Phase III clinical data demonstrate Best-in-Class efficacy in urticaria with CLDX holding a competitive late-stage development advantage relative to other early-stage competing KIT programs as well as existing drugs approved to treat CSU (e.g, Xolair, Dupixent, etc.). With 1.8 million patients suffering from CSU worldwide, this first mast cell driven condition alone represents a major commercial opportunity.
1,939 patients (n=963 EMBARQ-CSU1; n=976 EMBARQ-CSU2) were randomized to barzo 150mg Q4W (following 300mg loading dose), barzo 300mg Q8W (following 450mg loading dose) or placebo for 52 weeks. At 24 weeks, patients on placebo will be re-randomized to active treatment across both dosing groups. The studies were conducted in 43 countries and over 500 sites. Primary endpoint is mean change UAS7 at week 12 from baseline. The study is designed to detect a clinically meaningful difference between each of the active arms versus placebo in the overall population as well as in the subpopulation of omalizumab (Xolair) refractory patients. Topline data are expected now in Q4:26 – before today no one expect the data this year. In our view, the barzo train has just left the station.
Just in time for AAAAI – With three new barzo clinical updates being presented this weekend at the AAAAI Annual Meeting in Philadelphia, the conference will continue to build on the already impressive clinical database for barzo. For example, there is further positive read through from CLDX’s Phase II CIndU study (chronic inducible urticaria). In November 2025, CLDX presented updated Phase II data for barzo in CIndU with 20-week results demonstrating robust complete response rates of up to 66% in ColdU and 49% in symptomatic dermatographism (SD). At AAAAI 2026, CLDX will present open-label extension data from this study via a late-breaking poster on Sunday, March 1 (Abstract L41). Following the 20-week treatment period, patients were observed for an additional 24 weeks, during which those who experienced disease recurrence were eligible for open-label barzo retreatment. Importantly, the AAAAI abstract will show that re-treatment with barzo led to complete responses in the majority of patients with ColdU and SD. We believe these findings suggest barzo may be able to rapidly re-establish disease control in patients who relapse during off-treatment monitoring. Several Wall Street firms (e.g., LifeSci, Leerink) will be hosting KOL meetings at AAAAI this weekend and next.
No One Expected This (Except Maybe Us), But CLDX Has A Data Catalyst-Rich 2026. CLDX is well positioned with multiple Phase II readouts and key Phase III CSU data. The Phase III trial in ColdU and the SD study (NCT07266402) evaluating barzo was initiated in Jan 2026. The Phase II studies in prurigo nodularis (PN) and atopic dermatitis (AD) are currently enrolling with guidance for initial data in H2:26. Lastly, CLDX presented initial Phase 1 data for CDX-622 (bispecific SCF / TSLP antibody) in healthy volunteers last month showing that CDX-622 was well tolerated and induced rapid, sustained, and dose-dependent reductions in serum tryptase (see our note HERE). Enrollment for Part 2 is underway, with data expected in Q3:26. A proof-of-mechanism study for CDX-622 in mild-to-moderate asthma is also planned for 2026. The first patient will be treated any day.