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.
Select a button below to view the list of FDA events for that drug.
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 10, 2026
- Indication:
- For Prurigo Nodularis
Announcement
Celldex announced today that three presentations from the barzolvolimab and CDX-622 programs will be shared at the upcoming European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress being held in Istanbul, Türkiye, on June 12-15, 2026.
AI Summary
Celldex announced that three new research presentations from its barzolvolimab and CDX-622 programs will be shown at the EAACI Annual Congress in Istanbul, Türkiye, from June 12 to 15, 2026. Two flash talks will focus on barzolvolimab, a treatment being studied for chronic spontaneous urticaria and cold urticaria. These presentations will highlight long-term results and patient-reported itch data, which support the drug’s possible strong benefit in these conditions.
A third presentation will share first-in-human Phase 1 results for CDX-622, a bispecific antibody being tested in healthy volunteers. The study looks at a new way to target mast cell activity by combining effects on soluble stem cell factor and TSLP. Celldex said all three presentations will be posted on its website at the listed times. The company says the data further support its research pipeline in allergy and mast cell-related diseases.
Read Announcement- Drug:
- Barzolvolimab
- Announced Date:
- March 27, 2026
- Indication:
- For Prurigo Nodularis
Announcement
Celldex presented additional positive data from the completed Phase 2 clinical trials of barzolvolimab in chronic spontaneous urticaria (CSU) and cold urticaria (ColdU) and symptomatic dermographism (SD) demonstrating profound improvements in patient quality of life (QoL) across all measured domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships and treatment. Barzolvolimab is a humanized monoclonal antibody with a completely novel mechanism of action that uniquely targets the root cause of CSU, ColdU and SD—the mast cell.
AI Summary
Celldex reported additional positive results from completed Phase 2 trials of barzolvolimab in chronic spontaneous urticaria (CSU), cold urticaria (ColdU) and symptomatic dermographism (SD). Patients treated with barzolvolimab showed broad, meaningful improvements in quality of life measured by the Dermatology Life Quality Index (DLQI). Scores improved across all six DLQI domains—symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment—indicating relief that touched many parts of patients’ lives.
Barzolvolimab is a humanized monoclonal antibody with a novel mechanism that directly targets mast cells, the root cause of CSU, ColdU and SD. Celldex described the drug as first-in-class with a best-in-disease profile based on these findings. The analyses showed prolonged and enhanced quality of life after treatment, supporting further development. Posters summarizing the data, including analyses by M. Metz et al., are available on the Celldex website.
Read Announcement- Drug:
- Barzolvolimab
- Announced Date:
- March 1, 2026
- Indication:
- For Prurigo Nodularis
Announcement
Celldex presented new positive data from the Phase 2 ColdU and SD Open Label Extension (OLE), highlighting that retreatment with barzolvolimab leads to rapid improvement in urticaria control after symptom recurrence.
AI Summary
Celldex presented new Phase 2 data from the ColdU and SD open-label extension showing that retreatment with barzolvolimab quickly restores control of urticaria after symptoms return. In a late-breaking poster at AAAAI, investigators reported that patients who needed another course of the monoclonal antibody experienced rapid symptom improvement, with clinical benefit similar in size and speed to their first exposure.
The results suggest barzolvolimab could be used intermittently in routine care: patients might pause treatment after remission and be successfully re-treated if symptoms recur. This retreatment effect supports flexibility in long-term management of ColdU and SD, offering a potential real-world approach that balances disease control and treatment burden. Further study will clarify optimal re-treatment timing and safety, but these findings are promising for patients and clinicians seeking flexible options.
Read Announcement- Drug:
- Barzolvolimab
- Announced Date:
- February 27, 2026
- Indication:
- For Prurigo Nodularis
Announcement
Celldex presented additional positive data from the completed Phase 2 clinical trials of barzolvolimab in chronic spontaneous urticaria (CSU) and cold urticaria (ColdU) and symptomatic dermographism (SD).
AI Summary
Celldex presented additional positive data from completed Phase 2 clinical trials of barzolvolimab in chronic spontaneous urticaria (CSU), cold urticaria (ColdU) and symptomatic dermographism (SD). Martin Metz, M.D., reported a prolonged off-treatment effect in CSU, meaning some patients maintained benefit after stopping the drug. A 20-week analysis in chronic inducible urticaria showed improved urticaria control and better patient-reported quality of life. These findings were highlighted in related abstracts and a press release by AAAAI.
The Phase 2 results suggest barzolvolimab can reduce symptoms across different urticaria types and may deliver lasting benefit beyond the treatment period. While larger trials are needed to confirm these outcomes, the data support continued development of barzolvolimab as a potential treatment option for patients with CSU, ColdU and SD who have unmet needs. The presentations reinforce consistent efficacy signals across the studied urticaria conditions.
Read Announcement- Drug:
- Barzolvolimab
- Announced Date:
- February 25, 2026
- Indication:
- For Prurigo Nodularis
Announcement
Celldex the completion of enrollment in the Company's global Phase 3 program of barzolvolimab in chronic spontaneous urticaria (CSU), which consists of two Phase 3 trials—EMBARQ-CSU1 and EMBARQ-CSU2. 1,939 patients were enrolled—the largest program conducted in antihistamine refractory CSU, including patients with advanced therapy experienced/refractory CSU.
AI Summary
Celldex announced completion of enrollment in its global Phase 3 program of barzolvolimab for chronic spontaneous urticaria (CSU), comprising two trials, EMBARQ‑CSU1 and EMBARQ‑CSU2. The program enrolled 1,939 patients, making it the largest clinical program in antihistamine‑refractory CSU and including patients who are experienced with or refractory to advanced therapies. Enrollment finished six months ahead of the company’s guidance, highlighting a strong unmet need for better CSU treatments.
Topline data are expected in Q4 2026, and Celldex plans a biologics license application (BLA) submission in 2027. These are forward‑looking timelines and subject to change; the company cautions against placing undue reliance on forward‑looking statements. Contact and corporate notice information accompanied the announcement.
Read Announcement- Drug:
- Barzolvolimab
- Announced Date:
- February 23, 2026
- Indication:
- For Prurigo Nodularis
Announcement
Celldex announced that multiple presentations from the Company's Phase 2 clinical trials of barzolvolimab in chronic spontaneous urticaria (CSU) and cold urticaria (ColdU) and symptomatic dermographism (SD) have been accepted for presentation at the 2026 American Academy of Allergy, Asthma & Immunology's (AAAAI) Annual Meeting being held in Philadelphia, February 27 – March 2.
AI Summary
Celldex announced that multiple presentations from its Phase 2 trials of barzolvolimab in chronic spontaneous urticaria (CSU), cold urticaria (ColdU) and symptomatic dermographism (SD) were accepted for the 2026 AAAAI Annual Meeting in Philadelphia, Feb. 27–Mar. 2. The company will present results showing treatment benefits and quality-of-life improvements across inducible and spontaneous urticarias.
Key presentations include: a ColdU and SD poster, “Treatment with Barzolvolimab Improves Urticaria Control and Quality of Life,” on 2/27/2026, 2:45–3:45 pm (Poster 072, Hall E); a CSU poster, “Prolonged Off-Treatment Efficacy of Barzolvolimab,” same session time (Poster 075, Hall E); and a late-breaking ColdU/SD poster on 3/1/2026, 9:45–10:45 am showing that retreatment leads to rapid improvement after symptom recurrence (Late Breaking Poster L41, Hall E).
All presentations will be posted on Celldex’s website at the listed dates and times. These findings come from the company’s Phase 2 program of barzolvolimab.
Read Announcement- Drug:
- Barzolvolimab
- Announced Date:
- December 9, 2025
- Indication:
- For Prurigo Nodularis
Announcement
Celldex announced the initiation of its global Phase 3 trial (EMBARQ-ColdU and SD) designed to establish the efficacy and safety of barzolvolimab in adult patients with cold urticaria (ColdU) and symptomatic dermographism (SD) who remain symptomatic despite H1 antihistamine treatment.
AI Summary
Celldex announced the start of its global Phase 3 trial, EMBARQ‑ColdU and SD, to test barzolvolimab in adults with cold urticaria (ColdU) and symptomatic dermographism (SD) who remain symptomatic despite H1 antihistamines. Patients who remain symptomatic after biologic treatment are also eligible. ColdU causes hives after cold exposure; SD causes hives after scratching or rubbing.
The randomized, double‑blind, placebo‑controlled study will enroll about 240 participants at roughly 75 sites in seven countries, split into two cohorts (≈120 ColdU, ≈120 SD). Participants will be randomized 1:1 to barzolvolimab (450 mg loading dose Day 1, then 150 mg every 4 weeks) or placebo for 24 weeks. The primary endpoint is the percent of patients with a complete response (negative provocation test) at Week 12 using TempTest® for ColdU and FricTest® for SD. Participants will be followed for 16 weeks after treatment.
Barzolvolimab is a humanized monoclonal antibody that blocks KIT to reduce mast cell activity. Phase 2 data showed rapid, durable benefits versus placebo and a tolerable safety profile, supporting this registrational Phase 3 program.
Read Announcement- Drug:
- Barzolvolimab
- Announced Date:
- November 6, 2025
- Indication:
- For Prurigo Nodularis
Announcement
Celldex announced new data on exploratory endpoints (UCT7) further demonstrating barzolvolimab's ability to improve urticaria control from the Company's recently completed Phase 2 study in chronic spontaneous urticaria (CSU).
AI Summary
Celldex Therapeutics reported new exploratory data from its Phase 2 chronic spontaneous urticaria (CSU) study showing that barzolvolimab significantly improved urticaria control as measured by the seven-day Urticaria Control Test (UCT7). At Week 12, patients receiving barzolvolimab experienced a mean UCT7 score increase more than double that of placebo, with over half achieving well-controlled disease versus fewer than one in five on placebo. These gains were maintained through the study’s final visit, signaling durable clinical benefit.
Barzolvolimab was generally well tolerated, with most adverse events being mild to moderate and few discontinuations. This profile, combined with clear improvements in UCT7 scores, supports further development of barzolvolimab as a potential new treatment option for CSU patients who remain symptomatic despite existing therapies.
Read Announcement- Drug:
- Barzolvolimab
- Announced Date:
- September 17, 2025
- Indication:
- For Prurigo Nodularis
Announcement
Celldex announced today new data demonstrating rapid and strong efficacy regardless of baseline immunoglobulin E (IgE) levels in patients with 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 announced new data showing that barzolvolimab works quickly and effectively in chronic spontaneous urticaria (CSU) patients, no matter their starting immunoglobulin E (IgE) levels. CSU is driven by overactive mast cells, which release chemicals causing itchy hives and swelling.
Barzolvolimab is a humanized antibody that binds with high specificity to the receptor tyrosine kinase KIT on mast cells. By blocking KIT’s activity, barzolvolimab disrupts processes essential for mast cell function and survival, reducing the release of inflammatory signals.
In both low (<40 IU/mL) and normal/high (>40 IU/mL) IgE groups, patients treated with barzolvolimab showed similar, rapid improvements in weekly urticaria activity scores (UAS7) and urticaria control test scores (UCT7) at 12 and 52 weeks. Rates of well-controlled and complete disease control were also comparable across subgroups.
These findings highlight the central role of mast cells in CSU and suggest that barzolvolimab’s novel mechanism could offer a meaningful treatment option for all patients, regardless of their disease endotype.
Read Announcement- Drug:
- Barzolvolimab
- Announced Date:
- August 19, 2025
- Indication:
- For Prurigo Nodularis
Announcement
Celldex Therapeutics, Inc today reported topline results from the Company's ongoing Phase 2 study of barzolvolimab in eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus.
AI Summary
Celldex Therapeutics today announced topline Phase 2 results for barzolvolimab in eosinophilic esophagitis (EoE), a chronic inflammatory disease of the esophagus. The study aimed to test whether depleting mast cells in the esophageal lining would improve patient symptoms and disease markers. Participants received 300 mg of barzolvolimab every four weeks or placebo, with mast cell counts measured over 12 weeks.
The trial met its primary endpoint by showing a profound reduction in intraepithelial mast cells (–36.0 cells per high-power field vs. –2.7 for placebo; p<0.0001). However, this depletion did not translate into better outcomes on the Dysphagia Symptom Questionnaire or endoscopic scores. Rates of esophageal eosinophil counts and patient-reported symptoms were similar to placebo, and no new safety concerns emerged at the tested dose.
Based on these findings, Celldex will discontinue development of barzolvolimab for EoE but will continue exploring its potential in other gastrointestinal and inflammatory conditions driven by mast cells.
Read Announcement- 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
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:
- June 10, 2026
- Indication:
- For the Treatment of Inflammatory Diseases
Announcement
Celldex announced today that three presentations from the barzolvolimab and CDX-622 programs will be shared at the upcoming European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress being held in Istanbul, Türkiye, on June 12-15, 2026.
AI Summary
Celldex said it will share three presentations at the European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress in Istanbul, Türkiye, on June 12-15, 2026. Two flash talks will focus on barzolvolimab, with new results in chronic spontaneous urticaria and cold urticaria. These data are said to support the drug’s strong profile as a possible best-in-class treatment.
The company will also present a late-breaking poster on CDX-622, a new bispecific antibody. The study includes first-in-human results from a Phase 1 trial in healthy volunteers. Celldex said the findings highlight the potential of CDX-622 to target both soluble stem cell factor and TSLP, which may help block KIT signaling in mast cells.
All three presentations will be posted on the Celldex website at the scheduled times.
Read Announcement- 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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