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Celldex Therapeutics
Celldex Therapeutics (CLDX) investor relations material
Celldex Therapeutics Guggenheim Securities Emerging Outlook: Biotech Summit 2026 summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Guggenheim Securities Emerging Outlook: Biotech Summit 2026 summary11 Feb, 2026
Key milestones and clinical development
Initiated two phase 3 studies in cold urticaria and symptomatic dermographism in December 2025, each with 120 patients, targeting 18-month timelines.
Ongoing two large phase 3 CSU studies across 500+ centers in 43 countries, aiming for 1,830 patients and enrollment completion by summer 2026.
Phase 2 studies in prurigo nodularis and atopic dermatitis completed; data readouts expected in the second half of 2026, with phase 3 studies to follow based on results.
Exploring additional indications such as food allergy, allergic rhinitis, and chronic pruritic itch, with potential development starting late 2026 or 2027.
Bispecific antibody CDX-622 in healthy volunteer studies, with multiple ascending dose and subcutaneous data expected in summer; proof-of-mechanism asthma study initiated.
Clinical data and physician feedback
Phase 2 CSU data show rapid and high complete response rates (up to 70%) and durable effects, with 41% maintaining response seven months post-treatment.
Quality of life and angioedema improvements reported, generating strong enthusiasm among investigators.
Long-term durability data presented at major conferences, with ongoing discussions about changing treatment paradigms.
Retreatment in CIndU study demonstrated successful efficacy upon symptom recurrence.
Safety and study design
Safety profile remains consistent and well-tolerated, with mild, reversible side effects related to KIT inhibition.
Phase 3 CSU studies closely mirror phase 2 design, with the addition of a loading dose; primary endpoint at 12 weeks, but full analysis after 24 weeks.
Large safety database being built with over 1,800 patients in CSU studies, supporting regulatory requirements.
Commercial differentiation for Barzolvolimab
CDX-622: How to prioritize future indications
CSU Phase 3 data readout timing?
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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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