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Celldex Therapeutics Inc (CLDX)
NASDAQ:CLDX
barzolvolimab
Chronic Inducible Urticaria, Symptomatic Dermographism, Cold Urticaria, Cold-Induced Urticaria
Phase III
Recruiting
A Study to Investigate Efficacy, Safety and Tolerability of Barzolvolimab Versus Placebo in Adults With Cold Induced Urticaria and Symptomatic Dermographism Inadequately Controlled by H1-antihistamines (EMBARQ - ColdU and SD)
Nov 19, 2025
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barzolvolimab
Atopic Dermatitis
Phase II
Recruiting
A Study of Barzolvolimab in Patients With Atopic Dermatitis
Dec 09, 2024
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Normal Saline, Cdx-622
Healthy Participants
Phase I
Recruiting
A Phase I Study of CDX-622
Oct 18, 2024
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Cdx-585
Primary Peritoneal Carcinoma, Ovarian Cancer, Non-small Cell Lung Cancer, Colorectal Cancer, Fallopian Tube Cancer, Renal Cell Carcinoma, Gastric Cancer, Pancreatic Cancer, Esophageal Cancer, Head And Neck Cancer, Bladder Urothelial Carcinoma, Hepatic Cancer, Other Solid Tumors, Cholangiocarcinoma
Phase I
Completed
A Study of CDX-585 in Patients With Advanced Malignancies
Mar 15, 2023
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barzolvolimab
Eosinophilic Esophagitis
Phase II
Active Not Recruiting
A Study of CDX-0159 in Patients With Eosinophilic Esophagitis
Mar 07, 2023
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Cdx-1140, Odetiglucan
Metastatic Pancreatic Adenocarcinoma
Phase I
Terminated
A Maintenance Therapy Study of Odetiglucan With CDX-1140 in Patients With Metastatic Pancreatic Ductal Adenocarcinoma
Jul 15, 2022
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Celldex Therapeutics Inc (CLDX) have in its pipeline
CLDX is currently developing the following drugs: Standard of Care, barzolvolimab, barzolvolimab, barzolvolimab. These drug candidates are in various stages of clinical development as the company works toward FDA approval.