Celldex Presents Long-Term Results of Barzolvolimab Study
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 14 2026
0mins
Celldex announced the presentation of long-term results from the Phase 2 study of barzolvolimab in a flash talk session at the European Academy of Allergy and Clinical Immunology, EAACI, Annual Meeting in Istanbul, Turkiye. The data presented demonstrated that barzolvolimab treatment results in "rapid, significant, and durable improvements" in angioedema in patients with chronic spontaneous urticaria refractory to antihistamines. These results were sustained off-treatment, seven months after completion of barzolvolimab dosing. The data continue to demonstrate barzolvolimab's potential to shift the goal of CSU treatment from symptom control to disease modification and further support the ongoing Phase 3 trials of barzolvolimab in CSU.
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Analyst Views on CLDX
Wall Street analysts forecast CLDX stock price to rise
10 Analyst Rating
9 Buy
0 Hold
1 Sell
Strong Buy
Current: 36.780
Low
24.00
Averages
55.00
High
90.00
Current: 36.780
Low
24.00
Averages
55.00
High
90.00
About CLDX
Celldex Therapeutics, Inc. is a clinical-stage biotechnology company. The Company is focused on exploring the science of mast cell biology and the development of transformative therapeutics for patients. Its pipeline includes antibody-based therapeutics which have the ability to engage the human immune system and/or directly affect critical pathways to improve the lives of patients with severe inflammatory, allergic, autoimmune and other devastating diseases. Its drug candidates include monoclonal and bispecific antibodies designed to address mast cell mediated diseases. Its Barzolvolimab (CDX-0159) is a monoclonal antibody that specifically binds the KIT receptor and potently inhibits its activity, which is being studied across multiple mast cell driven diseases, including Chronic Urticarias, Prurigo Nodularis, Atopic Dermatitis and Eosinophilic Esophagitis. The Company’s bispecific platform includes CDX- 622. The CDX- 622 is a bispecific candidate for inflammatory diseases.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Biotech Sector Sees FDA Approvals and Layoffs
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- Expanded Injectable Indication: AbbVie's SKINVIVE received FDA approval to improve neck lines in adults over 21, with pivotal studies showing nearly 75% of patients achieving significant improvement at one month, further solidifying AbbVie's leadership in the aesthetics market.
- Strategic Acquisition: Biogen agreed to acquire RayThera for up to $1 billion to expand its immunology portfolio, with the transaction expected to close in Q3 2026, enhancing Biogen's competitive position in the immunotherapy space.
- Layoff Plans: Neumora Therapeutics announced a 35% workforce reduction to save $10 million annually, reflecting strategic adjustments following the failure to meet primary endpoints in clinical trials, aimed at extending cash runway.
See More
Celldex Reports Positive Phase 2b Data for Barzolvolimab in Angioedema Treatment
- Clinical Trial Results: Celldex presented positive data for Barzolvolimab at the EAACI 2026 annual meeting, demonstrating significant symptom improvement in patients with chronic spontaneous urticaria (CSU) over a 52-week trial, with statistically significant improvements in the weekly urticaria activity score (UAS7) by week 12.
- Patient Response: Data shows that up to 64% of patients were angioedema-free at 7 months post last dose, indicating the drug's long-term efficacy, which significantly enhances patients' quality of life and mental health outcomes.
- Ongoing Research Plans: Celldex is conducting two Phase 3 trials for angioedema in CSU, enrolling 1,939 patients across 500 sites in 43 countries, with topline data expected in Q4 2026 and a biologics license application (BLA) submission planned for 2027.
- Multiple Indication Exploration: In addition to CSU, Barzolvolimab is being tested for cold urticaria, symptomatic dermographism, prurigo nodularis, and atopic dermatitis, showcasing its potential applications across various hypersensitivity and inflammatory diseases.
See More
Barzolvolimab Significantly Improves Angioedema in Chronic Spontaneous Urticaria Patients
- Significant Efficacy: After treatment with barzolvolimab, up to 64% of patients remained angioedema-free at Week 76 post-dosing, demonstrating its durable efficacy in chronic spontaneous urticaria (CSU) patients and the potential to shift treatment goals from symptom control to disease modification.
- Clinical Trial Support: Two ongoing Phase 3 trials have completed enrollment of 1,939 patients, making it the largest study in antihistamine-refractory CSU, with topline data expected in Q4 2026 to support a planned Biologics License Application (BLA) in 2027.
- Improved Quality of Life: Barzolvolimab treatment not only significantly reduced the incidence of angioedema but also improved patients' quality of life, alleviating anxiety and depression symptoms associated with angioedema, indicating its potential to enhance overall health outcomes.
- Innovative Mechanism: As a humanized monoclonal antibody, barzolvolimab targets mast cells by specifically binding to the KIT receptor, inhibiting their activity, and showcasing significant potential as a first-in-class treatment option for CSU, cold urticaria, and symptomatic dermographism.
See More
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- Clinical Trial Results: Celldex presented positive Phase 1 results for CDX-622 at the EAACI Annual Meeting in Istanbul, demonstrating rapid and durable reductions in serum tryptase levels in healthy participants, indicative of effective mast cell depletion.
- Good Tolerability: CDX-622 was well-tolerated across all dose levels without dose-limiting toxicities or serious adverse events, with the most common adverse effect being Grade 1 headache, highlighting its potential for clinical application.
- Innovative Mechanism: CDX-622 selectively inhibits mast cells by neutralizing soluble stem cell factor (SCF) and thymic stromal lymphopoietin (TSLP), marking the first demonstration of this mechanism's effectiveness and providing a new approach for treating various inflammatory diseases.
- Future Research Directions: Celldex plans to initiate further proof-of-concept studies in multiple indications, including allergic rhinitis and food allergies, aiming to leverage the dual neutralization mechanism of CDX-622 to enhance therapeutic efficacy and address unmet medical needs.
See More
Celldex Reports Q1 Earnings Miss with Significant Revenue Decline
- Earnings Report Miss: Celldex's Q1 GAAP EPS of -$1.18 missed expectations by $0.02, indicating ongoing challenges in profitability that could undermine investor confidence.
- Significant Revenue Decline: The company reported revenue of only $0.015M for the quarter, a staggering 98.6% year-over-year decrease, reflecting severe issues in market demand and product sales that may lead to future cash flow constraints.
- Cash Position: As of March 31, 2026, Celldex held $451.5 million in cash and marketable securities, down from $518.6 million at the end of 2025, primarily due to $65.6 million used in operating activities during Q1, highlighting a need for improved cash management.
- Stock Offering Financing: In April 2026, Celldex issued 11,896,750 shares of common stock in a public offering, raising $345.0 million in gross proceeds, which will support the launch of Barzolvolimab, although this may dilute existing shareholders in the short term.
See More
Major Wall Street Rating Updates on Monday
- Tesla Rating Adjustment: Jefferies raised Tesla's price target from $300 to $350, anticipating Q1 results will show a widening gap between vision and execution, and concerns about funding may arise without a convincing robotaxi announcement, potentially leading to merger considerations with SpaceX.
- Apple's Positive Outlook: Morgan Stanley reiterated Apple as overweight, expecting a modest 1-2% upside in revenue and EPS in the upcoming earnings report, despite supply constraints, indicating the company's resilience in the market.
- Amazon Price Target Increase: Bank of America raised Amazon's price target from $275 to $298, believing that with strong assets and customer focus, Amazon is well-positioned to capitalize on the global growth of eCommerce and enterprise demand for AI capabilities, showcasing robust growth potential.
- Microsoft's Favorable Outlook: Deutsche Bank reiterated Microsoft as a buy, expecting Azure's performance and guidance to be focal points in the upcoming earnings report, indicating that the company's broad progress in AI initiatives will drive future growth.
See More
Biotech Sector Sees FDA Approvals and Layoffs
- FDA Drug Approval: Spero Therapeutics and GSK announced FDA approval for Utebzi, the first oral carbapenem for complicated urinary tract infections, marking a significant advancement in treatment options for adults with limited choices, which is expected to enhance market share.
- Expanded Injectable Indication: AbbVie's SKINVIVE received FDA approval to improve neck lines in adults over 21, with pivotal studies showing nearly 75% of patients achieving significant improvement at one month, further solidifying AbbVie's leadership in the aesthetics market.
- Strategic Acquisition: Biogen agreed to acquire RayThera for up to $1 billion to expand its immunology portfolio, with the transaction expected to close in Q3 2026, enhancing Biogen's competitive position in the immunotherapy space.
- Layoff Plans: Neumora Therapeutics announced a 35% workforce reduction to save $10 million annually, reflecting strategic adjustments following the failure to meet primary endpoints in clinical trials, aimed at extending cash runway.
See More
Celldex Reports Positive Phase 2b Data for Barzolvolimab in Angioedema Treatment
- Clinical Trial Results: Celldex presented positive data for Barzolvolimab at the EAACI 2026 annual meeting, demonstrating significant symptom improvement in patients with chronic spontaneous urticaria (CSU) over a 52-week trial, with statistically significant improvements in the weekly urticaria activity score (UAS7) by week 12.
- Patient Response: Data shows that up to 64% of patients were angioedema-free at 7 months post last dose, indicating the drug's long-term efficacy, which significantly enhances patients' quality of life and mental health outcomes.
- Ongoing Research Plans: Celldex is conducting two Phase 3 trials for angioedema in CSU, enrolling 1,939 patients across 500 sites in 43 countries, with topline data expected in Q4 2026 and a biologics license application (BLA) submission planned for 2027.
- Multiple Indication Exploration: In addition to CSU, Barzolvolimab is being tested for cold urticaria, symptomatic dermographism, prurigo nodularis, and atopic dermatitis, showcasing its potential applications across various hypersensitivity and inflammatory diseases.
See More
Barzolvolimab Significantly Improves Angioedema in Chronic Spontaneous Urticaria Patients
- Significant Efficacy: After treatment with barzolvolimab, up to 64% of patients remained angioedema-free at Week 76 post-dosing, demonstrating its durable efficacy in chronic spontaneous urticaria (CSU) patients and the potential to shift treatment goals from symptom control to disease modification.
- Clinical Trial Support: Two ongoing Phase 3 trials have completed enrollment of 1,939 patients, making it the largest study in antihistamine-refractory CSU, with topline data expected in Q4 2026 to support a planned Biologics License Application (BLA) in 2027.
- Improved Quality of Life: Barzolvolimab treatment not only significantly reduced the incidence of angioedema but also improved patients' quality of life, alleviating anxiety and depression symptoms associated with angioedema, indicating its potential to enhance overall health outcomes.
- Innovative Mechanism: As a humanized monoclonal antibody, barzolvolimab targets mast cells by specifically binding to the KIT receptor, inhibiting their activity, and showcasing significant potential as a first-in-class treatment option for CSU, cold urticaria, and symptomatic dermographism.
See More
Celldex's CDX-622 Shows Promising Phase 1 Results in Mast Cell Depletion
- Clinical Trial Results: Celldex presented positive Phase 1 results for CDX-622 at the EAACI Annual Meeting in Istanbul, demonstrating rapid and durable reductions in serum tryptase levels in healthy participants, indicative of effective mast cell depletion.
- Good Tolerability: CDX-622 was well-tolerated across all dose levels without dose-limiting toxicities or serious adverse events, with the most common adverse effect being Grade 1 headache, highlighting its potential for clinical application.
- Innovative Mechanism: CDX-622 selectively inhibits mast cells by neutralizing soluble stem cell factor (SCF) and thymic stromal lymphopoietin (TSLP), marking the first demonstration of this mechanism's effectiveness and providing a new approach for treating various inflammatory diseases.
- Future Research Directions: Celldex plans to initiate further proof-of-concept studies in multiple indications, including allergic rhinitis and food allergies, aiming to leverage the dual neutralization mechanism of CDX-622 to enhance therapeutic efficacy and address unmet medical needs.
See More
Celldex Reports Q1 Earnings Miss with Significant Revenue Decline
- Earnings Report Miss: Celldex's Q1 GAAP EPS of -$1.18 missed expectations by $0.02, indicating ongoing challenges in profitability that could undermine investor confidence.
- Significant Revenue Decline: The company reported revenue of only $0.015M for the quarter, a staggering 98.6% year-over-year decrease, reflecting severe issues in market demand and product sales that may lead to future cash flow constraints.
- Cash Position: As of March 31, 2026, Celldex held $451.5 million in cash and marketable securities, down from $518.6 million at the end of 2025, primarily due to $65.6 million used in operating activities during Q1, highlighting a need for improved cash management.
- Stock Offering Financing: In April 2026, Celldex issued 11,896,750 shares of common stock in a public offering, raising $345.0 million in gross proceeds, which will support the launch of Barzolvolimab, although this may dilute existing shareholders in the short term.
See More
Major Wall Street Rating Updates on Monday
- Tesla Rating Adjustment: Jefferies raised Tesla's price target from $300 to $350, anticipating Q1 results will show a widening gap between vision and execution, and concerns about funding may arise without a convincing robotaxi announcement, potentially leading to merger considerations with SpaceX.
- Apple's Positive Outlook: Morgan Stanley reiterated Apple as overweight, expecting a modest 1-2% upside in revenue and EPS in the upcoming earnings report, despite supply constraints, indicating the company's resilience in the market.
- Amazon Price Target Increase: Bank of America raised Amazon's price target from $275 to $298, believing that with strong assets and customer focus, Amazon is well-positioned to capitalize on the global growth of eCommerce and enterprise demand for AI capabilities, showcasing robust growth potential.
- Microsoft's Favorable Outlook: Deutsche Bank reiterated Microsoft as a buy, expecting Azure's performance and guidance to be focal points in the upcoming earnings report, indicating that the company's broad progress in AI initiatives will drive future growth.
See More
