Celldex Therapeutics (CLDX) Guggenheim Securities Emerging Outlook: Biotech Summit 2026 summary

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.