We are recommending Celldex Therapeutics Inc. (CLDX) as a more conservative biotech Top Pick for 2026. CLDX has just initiated the second Phase III/registration study with its lead compound barzolvolimab (“barzo”) in chronic inducible urticaria (CIndU), observes John McCamant, editor of Medical Technology Stock Letter.
This study will be identical to the Phase III CSU design, including a booster initial dose that will most likely improve efficacy during the start-up phase of the dosing, a well-known practice often performed with injectable monoclonal antibodies (MAbs). In our view, barzo is positioned to treat multiple mast cell diseases making it a pipeline in a drug - and a drug that will also command premium pricing.
Consensus by Wall Street models are using roughly $40,000 annual pricing for barzo. CLDX management has stated that because barzo efficacy lasts well more after stopping a year of dosing (76 weeks and counting), pricing and reimbursement is looking to be much higher than the consensus believes. For example, Dupixent is over $60,000 per year. Hence, we think the Street’s CLDX models and forecasts will move higher over time...and so should CLDX stock target prices.
With two Phase III trials for CIndU and CSU, barzo is already a pipeline in a drug. In our view, the next blockbuster indication for barzo will be food allergies. The door is wide open now with NVS’ Xolair gaining real traction on its recent food allergies FDA approvals/label expansion. CLDX will likely start a food allergy trial with barzo in 2026.
As a reminder, barzo in CSU works where Xolair does and does not and most importantly, in Xolair refractory patients, too. Food allergies make perfect sense for the next barzo mega indication. In addition to CSU, CIndu, PN (prurigo nodularis), AD (atopic dermatitis), and then food allergies will help barzo become a biotech blockbuster.
The differences between barzo and the company’s next mast cell MAb ‘622 is the binding and inhibition of stem cell factor (SCF - membrane expressed vs. soluble ‘248 which is blocked by CDX-622). Mast cells inhibited by ‘248 are responsible for inflammation/allergy conditions (vs. membrane which is hematopoetic/cancer-related conditions and may have more A/Es).
The combination of SCF/TSLP (the other specific target in this bi-specific MAb) is non-redundant and will hit different mast cell populations. In the healthy volunteer trials released in late 2025, tryptase was blocked 50% at the highest doses tested. It’s still early, but there is excitement as the Company expects to start trials in asthma soon and then other indications.
Recommended Action: Buy CLDX.
