This section highlights FDA-related milestones and regulatory updates for drugs developed by Celldex Therapeutics (CLDX).
Over the past two years, Celldex Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Barzolvolimab and CDX-622. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Barzolvolimab - FDA Regulatory Timeline and Events
Barzolvolimab is a drug developed by Celldex Therapeutics for the following indication: For Prurigo Nodularis.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Barzolvolimab
- Announced Date:
- June 14, 2025
- Indication:
- For Prurigo Nodularis
Announcement
Celldex Therapeutics, Inc. announced data demonstrating that barzolvolimab profoundly improves angioedema at 52 weeks in the Company's Phase 2 clinical trial in chronic spontaneous urticaria (CSU).
AI Summary
Celldex Therapeutics recently announced promising Phase 2 clinical trial results for barzolvolimab in patients with chronic spontaneous urticaria (CSU). The study showed that 77% of patients treated with a 150 mg dose every 4 weeks who had angioedema at the start were angioedema free at Week 52. Angioedema, a distressing symptom characterized by deep skin swelling, often poses significant challenges to daily life, making these findings especially noteworthy.
The trial demonstrated that barzolvolimab not only rapidly reduces angioedema symptoms but also provides durable improvements over a 52-week period. Improvements were measured using the weekly angioedema activity score (AAS7), which showed robust and sustained decreases in symptom severity. These results underline the potential of barzolvolimab to significantly enhance quality of life for patients with CSU by offering a long-term, effective treatment option.
Read Announcement- Drug:
- Barzolvolimab
- Announced Date:
- June 12, 2025
- Indication:
- For Prurigo Nodularis
Announcement
Celldex announced new data demonstrating profound, sustained complete response and improved quality of life at 76 weeks, 7 months after the completion of dosing with barzolvolimab in chronic spontaneous urticaria (CSU), an immune-related condition driven by mast cell activation. Barzolvolimab specifically targets mast cells by binding the receptor tyrosine kinase KIT with high specificity and potently inhibiting its activity, which is required for mast cell function and survival.
AI Summary
Celldex recently announced new data from a Phase 2 study demonstrating that barzolvolimab offers a profound and lasting benefit for patients with chronic spontaneous urticaria (CSU), an immune condition caused by overactive mast cells. Seven months after the treatment ended, 41% of patients receiving 150 mg every four weeks achieved a complete response with no hives or itching, while 48% experienced no impact on their quality of life. Barzolvolimab works by binding with high specificity to the KIT receptor tyrosine kinase, which is essential for mast cell function and survival, thereby inhibiting mast cell activation. The study also highlighted a favorable safety profile, noting that any adverse effects related to KIT were mild, reversible, and manageable. These results suggest that barzolvolimab could be a transformative treatment option for patients suffering from CSU.
Read Announcement- Drug:
- Barzolvolimab
- Announced Date:
- June 10, 2025
- Indication:
- For Prurigo Nodularis
Announcement
Celldex announced that data from the Company's Phase 2 study of barzolvolimab in chronic spontaneous urticaria will be presented at the EAACI Congress 2025 being held in Glasgow, Scotland.
AI Summary
Celldex announced that data from its Phase 2 study evaluating barzolvolimab for treating chronic spontaneous urticaria will be featured at the EAACI Congress 2025 in Glasgow, Scotland. The study focuses on both the 76-week efficacy and the tolerability of the drug, as well as long-term effects in controlling the disease even after the medication is withdrawn.
Abstracts related to the study will be available on the conference website starting Thursday, June 12th, with further discussions scheduled during a webcast on the same day at 6:00 pm ET. The presentation will offer detailed insights into how barzolvolimab may bring sustained improvements in symptoms for patients with chronic spontaneous urticaria, highlighting its potential as a new treatment option in the field of immunology.
Read Announcement- Drug:
- Barzolvolimab
- Announced Date:
- May 5, 2025
- Indication:
- For Prurigo Nodularis
Announcement
Celldex announced the presentation of histology data from the Company's ongoing Phase 2 study of barzolvolimab in eosinophilic esophagitis (EoE).
AI Summary
Celldex recently presented key histology data from its ongoing Phase 2 study of barzolvolimab in patients with eosinophilic esophagitis (EoE). The study’s biopsy results showed high numbers of intraepithelial mast cells that closely correlated with eosinophil counts. This finding reinforces the idea that mast cells play a significant role in EoE, a disease long believed to be driven only by eosinophils. Barzolvolimab, known for depleting mast cells in the skin, is being evaluated for its potential to reduce esophageal mast cells and improve clinical outcomes in EoE. Enrollment for the study is complete, and the company expects to share full clinical results in the second half of 2025. The data presented supports the hypothesis that targeting mast cells may offer a promising new treatment option for those suffering from EoE.
Read Announcement- Drug:
- Barzolvolimab
- Announced Date:
- March 1, 2025
- Indication:
- For Prurigo Nodularis
Announcement
Celldex Therapeutics, Inc. announced positive data on measurements of disease control and quality of life from the Company's Phase 2 barzolvolimab studies in patients with chronic urticaria.
AI Summary
Celldex Therapeutics, Inc. recently presented positive data from its Phase 2 studies on barzolvolimab, a humanized monoclonal antibody, which specifically targets the KIT receptor to inhibit mast cell function. The studies focused on patients with chronic urticaria, including chronic spontaneous urticaria (CSU) and chronic inducible urticaria (CIndU). In the 52-week CSU study, up to 82% of patients reported that their symptoms no longer impacted their quality of life, and up to 71% achieved complete response. Similarly, in the 12-week CIndU study, 60% of patients saw their symptoms cease to affect their quality of life. The data, measured by the Urticaria Control Test (UCT) and Dermatology Life Quality Index (DLQI), highlight rapid and sustained improvements in disease control and quality of life for patients suffering from chronic urticaria.
Read Announcement- Drug:
- Barzolvolimab
- Announced Date:
- December 19, 2024
- Indication:
- For Prurigo Nodularis
Announcement
Celldex Therapeutics, Inc. announced that the Company has initiated a Phase 2 study of barzolvolimab in atopic dermatitis (AD) and that the study is actively enrolling patients.
AI Summary
Celldex Therapeutics, Inc. has announced that it is initiating a Phase 2 study of its experimental drug barzolvolimab for the treatment of atopic dermatitis (AD). The study is actively enrolling patients to better understand how the drug can help manage the condition. Atopic dermatitis is a chronic skin disease that causes irritation, redness, and discomfort, and there remains a strong need for new treatment options. This clinical trial will assess the safety, tolerability, and effectiveness of barzolvolimab in improving skin symptoms related to AD. Celldex aims to gather important data that could pave the way for a new therapeutic alternative for patients who suffer from this challenging condition. The move marks an important step in Celldex’s efforts to address unmet medical needs in the treatment of atopic dermatitis.
Read Announcement- Drug:
- Barzolvolimab
- Announced Date:
- September 16, 2024
- Indication:
- For Prurigo Nodularis
Announcement
Celldex Therapeutics, Inc. announced that an abstract describing 52 week results from the Company's Phase 2 clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines, including patients with biologic-refractory disease, has been accepted as a late breaking oral presentation at the European Academy of Dermatology and Venereology (EADV) Congress 2024 being held in Amsterdam on September 25-28, 2024.
AI Summary
Celldex Therapeutics, Inc. announced that its 52-week Phase 2 study results for barzolvolimab, a potential treatment for chronic spontaneous urticaria (CSU) unresponsive to antihistamines, have been accepted as a late breaking oral presentation at the European Academy of Dermatology and Venereology (EADV) Congress 2024. The study focused on patients with moderate to severe CSU, including those whose disease did not improve with biologic therapies. Dr. Martin Metz, a professor of dermatology and allergy from Charité – Universitätsmedizin in Berlin, will present the findings on September 25, 2024, at 16:45 CEST in Amsterdam. These results highlight both profound efficacy and a favorable safety profile over a 52-week period. Additionally, an e-poster presentation focusing on 12-week improvements in quality of life and urticaria control will also be available at the congress.
Read Announcement- Drug:
- Barzolvolimab
- Announced Date:
- July 16, 2024
- Indication:
- For Prurigo Nodularis
Announcement
Celldex Therapeutics, Inc. announced the initiation of its global Phase 3 program, consisting of two Phase 3 trials (EMBARQ-CSU1 and EMBARQ-CSU2) designed to establish the efficacy and safety of barzolvolimab in adult patients with CSU who remain symptomatic despite H1 antihistamine treatment.
AI Summary
Celldex Therapeutics, Inc. has launched a global Phase 3 program featuring two trials—EMBARQ-CSU1 and EMBARQ-CSU2—to test the efficacy and safety of barzolvolimab in adults with chronic spontaneous urticaria (CSU). These studies focus on patients who continue to experience symptoms despite H1 antihistamine treatment, and they include both individuals new to biologic therapies and those with prior biologic exposure. The trials will enroll over 1,800 patients worldwide and are designed as randomized, double-blind, placebo-controlled studies. Patients will receive one of two dosing regimens of barzolvolimab or placebo for 52 weeks, with the primary goal being a reduction in urticaria activity scores by Week 12. This program represents a significant step toward providing improved treatment options for patients with long-term, severe CSU symptoms.
Read Announcement- Drug:
- Barzolvolimab
- Announced Date:
- April 17, 2024
- Indication:
- For Prurigo Nodularis
Announcement
Celldex Therapeutics, Inc announced that patient enrollment has been completed in the Company's Phase 2 clinical study of barzolvolimab for the treatment of the two most common forms of chronic inducible urticaria (CIndU)—cold urticaria (ColdU) and symptomatic dermographism (SD)..
AI Summary
Celldex Therapeutics, Inc. announced that patient enrollment has been completed for its Phase 2 study of barzolvolimab in the treatment of chronic inducible urticaria (CIndU), focusing on two common types: cold urticaria (ColdU) and symptomatic dermographism (SD). In this study, 196 patients were divided between the two subtypes—97 with ColdU and 99 with SD—and randomly assigned to receive one of two dosing regimens of barzolvolimab or a placebo. Barzolvolimab is a humanized monoclonal antibody that specifically targets the receptor tyrosine kinase KIT, which plays a key role in mast cell function and is thought to be critical in triggering the symptoms of these conditions. The primary goal of the study is to determine the effectiveness of the drug in achieving a negative provocation test at Week 12, with further data expected later this year.
Read Announcement
CDX-622 - FDA Regulatory Timeline and Events
CDX-622 is a drug developed by Celldex Therapeutics for the following indication: For the Treatment of Inflammatory Diseases.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- CDX-622
- Announced Date:
- March 3, 2025
- Indication:
- For the Treatment of Inflammatory Diseases
Announcement
Celldex Therapeutics, Inc. announced positive preclinical data from CDX-622, a novel bispecific antibody that targets two non-redundant, complementary pathways implicated in inflammation and fibrosis—thymic stromal lymphopoietin (TSLP) and mast cell depletion via stem cell factor (SCF) starvation.
AI Summary
Celldex Therapeutics announced positive preclinical data for its novel bispecific antibody, CDX-622. This antibody targets two key pathways that drive inflammation and fibrosis: thymic stromal lymphopoietin (TSLP) and stem cell factor (SCF). By neutralizing TSLP and inducing mast cell depletion through SCF starvation, CDX-622 shows promise in reducing tissue mast cells and dampening Type 2 inflammatory responses. The preclinical studies indicate that dual inhibition of these targets may offer enhanced benefits compared to therapies that focus on a single pathway. Data presented at the American Academy of Allergy, Asthma & Immunology Annual Meeting supports the potential of CDX-622 to improve treatment options for patients with inflammatory and fibrotic disorders. A Phase 1 study in healthy volunteers is now underway to assess the drug's safety, pharmacokinetics, and pharmacodynamics, marking an important step in its clinical development.
Read Announcement- Drug:
- CDX-622
- Announced Date:
- February 27, 2025
- Indication:
- For the Treatment of Inflammatory Diseases
Announcement
Celldex Therapeutics, Inc provided a corporate update.
AI Summary
Celldex Therapeutics provided an update on its ongoing clinical programs and new initiatives. The company highlighted that its Phase 3 trials for chronic spontaneous urticaria (CSU) are actively enrolling patients worldwide, and they plan to launch a Phase 3 program in chronic inducible urticaria (CIndU) later this year. Celldex emphasized that in 2024 they achieved breakthrough results with barzolvolimab in Phase 2 studies for both CSU and CIndU, establishing a new benchmark for efficacy in these conditions. Additionally, the company has expanded its portfolio by initiating a Phase 2 study in atopic dermatitis and progressing enrollment for other indications such as prurigo nodularis and eosinophilic esophagitis. They also introduced CDX-622, the first bispecific antibody targeting inflammatory diseases, which is now in a Phase 1 trial to assess its safety and therapeutic potential.
Read Announcement - Drug:
- CDX-622
- Announced Date:
- November 20, 2024
- Indication:
- For the Treatment of Inflammatory Diseases
Announcement
Celldex Therapeutics, Inc. announced that the first patient has been dosed in the Company's Phase 1a study of CDX-622 in healthy volunteers.
AI Summary
Celldex Therapeutics, Inc. announced that the first patient has been dosed in their Phase 1a clinical trial of CDX-622, an experimental bispecific antibody designed to target two pathways linked to chronic inflammation. The drug works by neutralizing thymic stromal lymphopoietin (TSLP) and reducing mast cells through stem cell factor (SCF) depletion. This dual approach aims to lower both mast cell numbers and Type 2 inflammatory responses, potentially offering benefits in treating respiratory and dermatological disorders.
The Phase 1a study is a double-blind, placebo-controlled, dose-escalation trial involving healthy volunteers. It will evaluate the safety, pharmacokinetics, and pharmacodynamics of single and multiple doses of CDX-622. Celldex plans to assess various biomarkers related to SCF and TSLP signaling and look forward to expanding the study into conditions such as asthma upon successful completion of this trial.
Read Announcement
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