Celldex Therapeutics (CLDX) TD Cowen Chronic Urticaria Summit summary

Key clinical data and upcoming milestones

• 52-week data from the CSU program will be presented at EADV, with additional quality-of-life results and angioedema data included in a poster presentation.

• Full CIndU 12-week data, including secondary endpoints and safety, will be presented at ACAAI, with follow-up and retreatment data expected in 2025.

• PN Phase 2 study is enrolling 120 patients, with primary endpoint at 12 weeks and possible data readout next year.

• EoE Phase 2 study is enrolling, with data expected in the first half of next year and full results likely in the second half.

• A dedicated study on male reproductive safety will start next month, running for about six months and reporting before Phase 3 data.

Efficacy, safety, and dosing insights

• Efficacy appears to improve beyond 12 weeks, with individual variability in response timing; mast cell depletion may deepen over time.

• Neutropenia is typically transient, stabilizing after four weeks, with no progressive worsening or infection correlation; baseline monitoring is recommended.

• Anaphylaxis risk is low (1 in 500), usually occurring early in treatment, consistent with other biologics.

• Tryptase is a key biomarker for mast cell activity; loading doses in Phase 3 aim to optimize efficacy, especially in heavier patients.

• Future studies may explore less frequent maintenance dosing (e.g., every 12 weeks), informed by ongoing recovery data collection.

Regulatory and commercial strategy

• Labeling aims to include antihistamine-refractory and omalizumab-refractory populations, with robust data expected for Xolair-naive patients.

• Market strategy targets 750,000 eligible patients in the US and EU, with broad efficacy across biologic-naive, experienced, and refractory groups.

• Dermatologists' adoption is expected to increase due to broad clinical experience across multiple indications by approval.