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Celldex (CLDX) Up Almost 40% Since Skin Disorder Study Data

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Shares of Celldex Therapeutics, Inc. CLDX surged 37.6% in the past two days, following announcement of encouraging data from an early-stage study evaluating its monoclonal antibody candidate CDX-0159 in patients with chronic inducible urticaria (CIU). All patients treated with the candidate achieved a clinical response, with 95% complete response rate.

A phase Ib study evaluated intravenous administration of a single dose of CDX-0159 in patients with the two most common forms of CIU — antihistamine refractory cold urticaria and symptomatic dermographism — in separate cohorts. Patients had high disease activity. Data from the study showed that all patients with cold urticaria in the study achieved complete response with most patients achieving it by week 1. Data from the symptomatic dermographism cohort demonstrated 89% complete response rate with one patient experiencing a partial response. Majority of patients in this group achieved complete response by week 4.

Moreover, the patients from both groups showed sustained durability of the clinical response. Median duration of response in the cold urticaria patients was more than 77 days, while the same was more than 55 days for patients with symptomatic dermographism.

The antibody candidate also achieved complete response in three CIU patients who were previously treated with Novartis NVS/Roche’s RHHBY urticaria drug, Xolair (omalizumab). Two among these patients were refractory to Xolair treatment.

Shares of Celldex have rallied 154.6% so far this year against the industry’s decrease of 2%.

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Based on this encouraging data, Celldex believes that CDX-0159 holds potential for treating other disease with mast cell involvement. The company plans to initiate studies on the candidate in patients with prurigo nodularis later this year, and in additional indications going forward. The company is also planning to initiate clinical study on the subcutaneous formulation of CDX-0159 in the third quarter of 2021.

Apart from CIU, the company is also developing CDX-0159 for treating patients with chronic spontaneous urticaria (CSU), another most frequent skin disease. Mid-stage studies to evaluate CIU and CSU patients are expected to start in the first half of 2022.

Apart from CDX-0159, Celldex is developing a CD40 human agonist antibody CDX-1140. The candidate is being developed as a potential treatment of solid tumors and B cell lymphomas as a monotherapy or in combination with Celldex’s CDX-301 or Merck’s MRK Keytruda.

The company initiated an early-stage study earlier this year to evaluate its new bispecific product candidate CDX-527 for solid tumors.

However, the company discontinued development of its lead pipeline candidate CDX-3379 last year due to discouraging clinical activity. It was being evaluated in a phase II study in combination with Eli Lilly’s Erbitux in patients with head and neck cancer.

Celldex Therapeutics, Inc. Price

Celldex Therapeutics, Inc. Price
Celldex Therapeutics, Inc. Price

Celldex Therapeutics, Inc. price | Celldex Therapeutics, Inc. Quote

Zacks Rank

Celldex currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.


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Novartis AG (NVS) : Free Stock Analysis Report

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