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Celldex Therapeutics
Celldex Therapeutics (CLDX) investor relations material
Celldex Therapeutics Evercore ISI 8th Annual HealthCONx Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Evercore ISI 8th Annual HealthCONx Conference summary2 Dec, 2025
Pipeline and clinical development updates
Phase III development ongoing for CSU, with accrual expected to complete by July 2026; phase III in CIndU to start by end of month.
Phase II studies in prurigo nodularis and atopic dermatitis expected to read out in 2026.
CDX-622, a bispecific targeting SCF and TSLP, is in healthy volunteer studies; multiple ascending dose (MAD) data expected Q3 2026.
Subcutaneous dosing and proof-of-mechanism study in severe asthma planned for 2026.
Additional allergic disease indications, including food allergy and allergic rhinitis, are under consideration.
Scientific rationale and biomarker strategy
CDX-622 targets soluble SCF-248, aiming to inhibit mast cells while minimizing KIT-related side effects.
Maximum 50% tryptase reduction observed in SAD; further reduction possible with MAD.
Skin punch biopsies and preclinical models will help identify mast cell populations most affected.
TSLP biomarker data to be gathered in an upcoming asthma study.
Each indication may require tailored biomarker benchmarks for optimal clinical activity.
Commercial and market access considerations
Barzol expected to launch behind omalizumab but could be used across antihistamine-refractory and biologic-experienced populations.
Pricing anticipated to exceed $59,000 annually, with payer discussions to determine final premium.
U.S. patient pool estimated to be 40% higher than 80,000 omalizumab users.
Market access and commercial teams being built to support launch and expansion.
Partnership opportunities considered, especially for ex-U.S. markets.
Clinical significance of 50% tryptase reduction?
Justify Barzal's premium pricing to payers
How does 622 validate the SCF-targeted platform?
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Next Celldex Therapeutics earnings date
Q4 202523 Feb, 2026
Celldex Therapeutics
Next Celldex Therapeutics earnings date
Q4 202523 Feb, 2026
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Frequently asked questions
Celldex Therapeutics, Inc. is a biopharmaceutical company specializing in the development of therapeutic monoclonal and bispecific antibodies. These antibodies are designed to treat a range of serious conditions, including inflammatory, allergic, and autoimmune diseases. The company's lead program focuses on developing barzolvolimab, a monoclonal antibody targeting KIT, a key receptor tyrosine kinase involved in mast cell function, which is crucial in the onset and progression of various severe diseases. Celldex Therapeutics is headquartered in Hampton, New Jersey, and its shares are listed on the NASDAQ.
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