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Celldex Therapeutics (CLDX) investor relations material

Celldex Therapeutics TD Cowen Immunology and Inflammation Summit summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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TD Cowen Immunology and Inflammation Summit summary13 Nov, 2025

Recent clinical data and competitive landscape

  • 76-week phase II data in CSU showed a 41% complete response rate seven months post-treatment, indicating unprecedented durability compared to competitors like Xolair and Dupixent.

  • Mast cells return to normal levels post-treatment, but disease modification is suggested by sustained response.

  • Ongoing phase III studies (EMBARK-CSU1 and CSU2) are enrolling, with primary endpoint data expected as early as the first half of next year.

  • Study design allows for statistical analysis in Xolair-refractory populations and robust safety data.

Future study directions and dosing strategies

  • Open-label extension (OLE) studies will explore retreatment and alternative dosing schedules, potentially including maintenance or less frequent dosing.

  • Phase IV studies may investigate real-world dosing regimens post-approval.

  • No special baseline monitoring for hypersensitivity beyond standard urticaria inclusion.

Pipeline updates: PN, AD, and CDX-622

  • Phase II studies in prurigo nodularis (PN) and atopic dermatitis (AD) are ongoing, with data expected in the second half of next year.

  • PN trial is placebo-controlled, testing two regimens, with endpoints focused on itch reduction and lesion healing.

  • AD phase II tests two regimens with a 16-week primary endpoint, focusing on non-histaminergic itch and inflammation.

  • CDX-622, a bispecific targeting stem cell factor and TSLP, showed promising phase I data with no immunogenicity and effective mast cell targeting.

  • Multiple ascending dose and subcutaneous formulation studies are ongoing, with future directions including asthma, COPD, chronic cough, and food allergy.

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Evercore ISI 8th Annual HealthCONx Conference2 Dec, 2025
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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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