CLDX Stock Down Despite Upbeat Long-Term Data From Urticaria Study

Core Viewpoint - Celldex Therapeutics' shares fell by 12.1% due to disappointing safety data from a mid-stage study of barzolvolimab, an investigational treatment for chronic spontaneous urticaria (CSU) [1] Group 1: Study Results - The phase II study involved 208 CSU patients and compared three dosing regimens of barzolvolimab (75 mg, 150 mg, 300 mg) against a placebo [1] - Statistically significant improvements in UAS7 scores were observed at week 12 and sustained through week 52 for all dose levels [2][3] - A complete response (UAS7 score of 0) was achieved in 71% of patients on the 150 mg dose and 52% on the 300 mg dose at week 52 [3] - 74% of patients on the 150 mg dose and 68% on the 300 mg dose had well-controlled disease (UAS7 score < 6) at week 52 [4] Group 2: Safety Concerns - Despite efficacy data, safety concerns arose as over 10% of barzolvolimab-treated patients experienced treatment-related adverse events, including hair color changes and neutropenia [5] - The company stated that adverse events were mostly mild and not related to dosage levels, with stable neutrophil counts during treatment [5] Group 3: Clinical Pipeline - Celldex has initiated a global phase III program for barzolvolimab, which includes two late-stage studies for adult CSU patients [6] - The company is also exploring barzolvolimab for other inflammatory diseases such as prurigo nodularis and atopic dermatitis [6] - Another candidate, CDX-585, is in phase I development for advanced or metastatic solid tumors [6] Group 4: Market Performance - Year-to-date, Celldex shares have declined by 9.2%, while the industry average decline is 1.9% [3]