Celldex Therapeutics, Inc. CLDX
Celldex Therapeutics, Inc. (Nasdaq: CLDX) is an immunology/inflammation drug developer. Its lead program, Barzolvolimab (CDX-0159), is in Phase 3 for Chronic Spontaneous Urticaria (CSU). Its next catalyst on record is barzolvolimab: Topline data from Phase 2 atopic dermatitis study expected in late 2026. (H2 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: barzolvolimab — Topline data from Phase 2 atopic dermatitis study expected in late 2026. (H2 2026). 2 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Barzolvolimab (CDX-0159) | Chronic Spontaneous Urticaria (CSU) | antibody | Phase 3 |
| Barzolvolimab (CDX-0159) | Cold Urticaria (ColdU) and Symptomatic Dermographism (SD) | antibody | Phase 3 |
| Barzolvolimab (CDX-0159) | Atopic Dermatitis (AD) | antibody | Phase 2 |
| CDX-622 (SCF & TSLP bispecific) | Mild to moderate asthma | antibody | Phase 1 |
Recent results and decisions
- Sep 22, 2026met EMBARQ-CSU1 met primary and all key secondary endpoints; UAS7 change at week 12 -20.2 (150 mg Q4W) and -20.5 (300 mg Q8W) vs -10.7 placebo, p<.00001.
Both Phase 3 trials met the primary endpoint of mean change from baseline in weekly urticaria activity score (UAS7) at Week 12, and all key secondary endpoints, demonstrating clinically meaningful and statistically significant improvements in disease activity.
Filing - met Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 studies of barzolvolimab in CSU met primary and all key secondary endpoints with unprecedented complete response rates.
The primary and all key secondary endpoints across both studies and both dose groups were met.
Filing - negative Phase 2 prurigo nodularis study discontinued based on topline data suggesting mast cells may not be the key pathogenic driver in PN.
Topline data from the Phase 2 study in prurigo nodularis (PN) were presented in July 2026 and suggested that mast cells may not be the key pathogenic driver in PN.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 immunology/inflammation companies
- Sanofi SNY
- Argenx SE ARGX
- Roivant Sciences Ltd. ROIV
- Immunovant, Inc. IMVT
- Biohaven Ltd. BHVN
- BioCryst Pharmaceuticals, Inc. BCRX
- Zenas BioPharma ZBIO
- Nektar Therapeutics NKTR
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.