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Celldex Stock Surges As It Touts Early-Stage Skin Disease Study Win For CDX-0159

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  • Celldex Therapeutics Inc (NASDAQ: CLDX) got a boost Friday with a data readout from Phase 1b trial of CDX-0159 in patients with antihistamine refractory cold urticaria and symptomatic dermographism.

  • The company said that among 19 patients who received a full dose of the antibody, 18 achieved a complete response, and the 19th saw a partial response.

  • The diseases in question are two forms of chronic inducible urticaria. The first, called symptomatic dermographism, make up more than half of cases. Patients can develop severe hives in response to little stimulation on the skin, such as putting on socks.

  • The second condition, known as "cold urticaria," makes up 16% of cases and causes hives outbreaks when skin is exposed below certain temperatures.

  • Eight of the nine symptomatic dermographism patients achieved complete response, including three who had previously been treated with Genetech - Novartis's Xolair (omalizumab). All 10 with cold urticaria met their complete response.

  • Celldex said the treatments proved highly durable. The symptomatic dermographism patients maintained their responses at a median of 57 days, and those with cold urticaria maintained the disease state for a median of 77 days.

  • A subcutaneous formulation of CDX-0159 is planned to enter the clinic in 3Q of 2021.

  • The company plans to initiate a study in prurigo nodularis in 4Q of 2021.

  • It remains on track to initiate Phase 2 studies in spontaneous and inducible urticaria in 1H of 2022.

  • Initial results from the cholinergic cohort and treatment results from the Phase 1b study in chronic spontaneous urticaria are planned for presentation at a scientific congress in 1Q of 2022.

  • The company plans to expand development into a fourth indication by year-end 2022.

  • Price Action: CLDX shares are up 34.2% at $43.50 during the premarket session on the last check Monday.

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