Celldex Therapeutics Presents Landmark 52 Week Results from Barzolvolimab Phase 2 Study in Chronic Spontaneous Urticaria at EADV 2024
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Sep 25 2024
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Should l Buy CLDX?
Source: Newsfilter
Efficacy of Barzolvolimab: New data from Celldex Therapeutics shows that 71% of patients treated with barzolvolimab for chronic spontaneous urticaria achieved complete response at Week 52, with significant improvements in disease control observed as early as Week 1 and sustained over the treatment period.
Safety Profile: Barzolvolimab demonstrated a well-tolerated safety profile throughout the 52 weeks, with most adverse events being mild and reversible, indicating its potential as a transformative treatment option for patients suffering from this debilitating condition.
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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: 23.570
Low
24.00
Averages
55.00
High
90.00
Current: 23.570
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.
CLDX Stock Price Fluctuation Analysis
- Price Range Analysis: CLDX's 52-week low is $14.40 per share, with a high of $30.50, while the last trade was at $23.64, indicating price fluctuations within this range and reflecting market caution regarding its future performance.
- Technical Indicator Focus: The stock price has fallen below the 200-day moving average, potentially signaling further downside risk in the short term, prompting investors to closely monitor market dynamics for strategic adjustments.
- Market Sentiment Assessment: With the current price nearing the 52-week low, investor sentiment may be dampened, which could affect overall confidence in CLDX and warrant vigilance against potential selling pressure.
- Investor Strategy Adjustment: Given the volatility in CLDX's stock price, investors may need to reassess their portfolios, considering whether to hold or reduce their positions in response to market uncertainties.
See More
Celldex Therapeutics' Jimenez Sells 4,166 Shares for $121,210
- Executive Trading Activity: Freddy A. Jimenez, Senior VP & General Counsel of Celldex, sold 4,166 shares on December 4, 2025, for $121,210 at a price of $29.09, reducing his direct ownership by 11.92%, indicating a cautious outlook on the company's future.
- Historical Comparison: This sale of 4,166 shares is significantly larger than Jimenez's previous sale of 771 shares on August 13, 2025, and exceeds the recent median sell size of 2,468 shares, suggesting a heightened sensitivity to market conditions.
- Company Financials: With a market capitalization of $1.82 billion, Celldex has faced deteriorating financials, reporting zero revenue in Q3 2025 and a net loss of $67 million, highlighting the severe challenges the company is currently facing.
- Other Executive Transactions: In early 2026, other executives also engaged in stock transactions, with CBO Pepin Ronald exercising options worth $105,744, reflecting differing perspectives among executives regarding the company's future despite the overall poor market performance.
See More
Celldex Offers $25 Put Option, Attracting Investor Interest
- Put Option Appeal: The current bid for the $25.00 put option is $3.90, and if an investor sells this option, they commit to buying the stock at $25.00, effectively lowering their cost basis to $21.10, which represents a 6% discount to the current price of $26.53, making it attractive for those looking to enter at a lower price.
- Return Potential Analysis: Should the put option expire worthless, it would yield a 15.60% return on cash commitment, or 23.53% annualized, positioning this option as an appealing investment choice, especially in a volatile market environment.
- Call Option Opportunity: The $34.00 call option has a current bid of $2.00, and if an investor buys shares at $26.53 and sells this call, they could achieve a total return of 35.70% if the stock is called away at the August 2026 expiration, providing an additional revenue opportunity for investors.
- Market Volatility Consideration: The implied volatility for the put option is 76%, while for the call option it is 68%, compared to an actual trailing twelve-month volatility of 58%, indicating significant uncertainty in market expectations for Celldex's stock performance.
See More
Celldex Initiates Global Phase 3 Trial for Cold Urticaria Treatment
- Clinical Trial Launch: Celldex has announced the initiation of its global Phase 3 trial for barzolvolimab, targeting efficacy and safety in patients with cold urticaria (ColdU) and symptomatic dermographism (SD), with approximately 240 participants expected to be recruited, indicating the company's proactive advancement in treatment options.
- Significant Efficacy: In the Phase 2 study, barzolvolimab demonstrated that up to 75% of ColdU patients and 67% of SD patients achieved partial or complete responses, highlighting the drug's substantial potential to improve patient quality of life.
- Market Demand: Over 533,000 patients in the U.S. and Europe are affected by ColdU and SD, with more than 80% reporting inadequate disease control from existing treatments, underscoring the urgent need for new therapeutic options.
- Strategic Implications: The development of barzolvolimab not only targets ColdU and SD but also includes ongoing Phase 3 studies in chronic spontaneous urticaria, showcasing its broad market application potential and aligning with the company's long-term growth strategy.
See More
Celldex Initiates Global Phase 3 Trial for Barzolvolimab Efficacy in ColdU and SD
- Trial Initiation: Celldex has announced the initiation of its global Phase 3 trial, EMBARQ-ColdU and SD, aimed at establishing the efficacy and safety of barzolvolimab in adult patients unresponsive to H1 antihistamine treatment, with plans to recruit 240 participants across 7 countries, highlighting the company's proactive approach in addressing cold urticaria and symptomatic dermographism.
- Significant Efficacy: In the Phase 2 study, barzolvolimab achieved a partial or complete response in up to 75% of cold urticaria patients and 67% of symptomatic dermographism patients at 12 weeks, indicating its potential to improve patient quality of life, especially in the absence of effective treatment options.
- Addressing Patient Needs: With over 533,000 patients affected by cold urticaria and symptomatic dermographism in the U.S. and Europe, and existing treatments proving inadequate, the development of barzolvolimab offers new hope for these patients, potentially leading to significant improvements in their quality of life and mental health.
- Future Outlook: As barzolvolimab advances across multiple indications, Celldex demonstrates its innovative capabilities in immunology, with expectations to provide more effective treatment options for patients, further solidifying its leadership position in the biopharmaceutical industry.
See More
Cleveland Diagnostics' IsoPSA Receives FDA Approval, Enhancing Prostate Biopsy Decision-Making
- FDA Approval Milestone: Cleveland Diagnostics' IsoPSA® in vitro diagnostic kit has received FDA approval through the Premarket Approval process, marking a significant advancement in early cancer detection and is expected to greatly enhance physician confidence in prostate biopsy decision-making.
- Clinical Research Support: The FDA approval of IsoPSA is based on robust clinical evidence from a large-scale prospective study conducted at 14 sites across the U.S., addressing the diagnostic gap where over 1 million men undergo prostate biopsies annually, yet only 25% yield positive results for high-grade disease.
- Cost Reduction in Healthcare: By providing more accurate risk assessments, IsoPSA helps reduce unnecessary invasive procedures and associated healthcare costs, which is anticipated to alleviate physical risks and emotional stress for patients, thereby improving the overall healthcare experience.
- Market Access Expansion: Since its introduction as a Laboratory-Developed Test (LDT) in 2020, IsoPSA has gained coverage from Medicare and an increasing number of commercial payors, further driving its application in clinical practice and enhancing patient accessibility.
See More
CLDX Stock Price Fluctuation Analysis
- Price Range Analysis: CLDX's 52-week low is $14.40 per share, with a high of $30.50, while the last trade was at $23.64, indicating price fluctuations within this range and reflecting market caution regarding its future performance.
- Technical Indicator Focus: The stock price has fallen below the 200-day moving average, potentially signaling further downside risk in the short term, prompting investors to closely monitor market dynamics for strategic adjustments.
- Market Sentiment Assessment: With the current price nearing the 52-week low, investor sentiment may be dampened, which could affect overall confidence in CLDX and warrant vigilance against potential selling pressure.
- Investor Strategy Adjustment: Given the volatility in CLDX's stock price, investors may need to reassess their portfolios, considering whether to hold or reduce their positions in response to market uncertainties.
See More
Celldex Therapeutics' Jimenez Sells 4,166 Shares for $121,210
- Executive Trading Activity: Freddy A. Jimenez, Senior VP & General Counsel of Celldex, sold 4,166 shares on December 4, 2025, for $121,210 at a price of $29.09, reducing his direct ownership by 11.92%, indicating a cautious outlook on the company's future.
- Historical Comparison: This sale of 4,166 shares is significantly larger than Jimenez's previous sale of 771 shares on August 13, 2025, and exceeds the recent median sell size of 2,468 shares, suggesting a heightened sensitivity to market conditions.
- Company Financials: With a market capitalization of $1.82 billion, Celldex has faced deteriorating financials, reporting zero revenue in Q3 2025 and a net loss of $67 million, highlighting the severe challenges the company is currently facing.
- Other Executive Transactions: In early 2026, other executives also engaged in stock transactions, with CBO Pepin Ronald exercising options worth $105,744, reflecting differing perspectives among executives regarding the company's future despite the overall poor market performance.
See More
Celldex Offers $25 Put Option, Attracting Investor Interest
- Put Option Appeal: The current bid for the $25.00 put option is $3.90, and if an investor sells this option, they commit to buying the stock at $25.00, effectively lowering their cost basis to $21.10, which represents a 6% discount to the current price of $26.53, making it attractive for those looking to enter at a lower price.
- Return Potential Analysis: Should the put option expire worthless, it would yield a 15.60% return on cash commitment, or 23.53% annualized, positioning this option as an appealing investment choice, especially in a volatile market environment.
- Call Option Opportunity: The $34.00 call option has a current bid of $2.00, and if an investor buys shares at $26.53 and sells this call, they could achieve a total return of 35.70% if the stock is called away at the August 2026 expiration, providing an additional revenue opportunity for investors.
- Market Volatility Consideration: The implied volatility for the put option is 76%, while for the call option it is 68%, compared to an actual trailing twelve-month volatility of 58%, indicating significant uncertainty in market expectations for Celldex's stock performance.
See More
Celldex Initiates Global Phase 3 Trial for Cold Urticaria Treatment
- Clinical Trial Launch: Celldex has announced the initiation of its global Phase 3 trial for barzolvolimab, targeting efficacy and safety in patients with cold urticaria (ColdU) and symptomatic dermographism (SD), with approximately 240 participants expected to be recruited, indicating the company's proactive advancement in treatment options.
- Significant Efficacy: In the Phase 2 study, barzolvolimab demonstrated that up to 75% of ColdU patients and 67% of SD patients achieved partial or complete responses, highlighting the drug's substantial potential to improve patient quality of life.
- Market Demand: Over 533,000 patients in the U.S. and Europe are affected by ColdU and SD, with more than 80% reporting inadequate disease control from existing treatments, underscoring the urgent need for new therapeutic options.
- Strategic Implications: The development of barzolvolimab not only targets ColdU and SD but also includes ongoing Phase 3 studies in chronic spontaneous urticaria, showcasing its broad market application potential and aligning with the company's long-term growth strategy.
See More
Celldex Initiates Global Phase 3 Trial for Barzolvolimab Efficacy in ColdU and SD
- Trial Initiation: Celldex has announced the initiation of its global Phase 3 trial, EMBARQ-ColdU and SD, aimed at establishing the efficacy and safety of barzolvolimab in adult patients unresponsive to H1 antihistamine treatment, with plans to recruit 240 participants across 7 countries, highlighting the company's proactive approach in addressing cold urticaria and symptomatic dermographism.
- Significant Efficacy: In the Phase 2 study, barzolvolimab achieved a partial or complete response in up to 75% of cold urticaria patients and 67% of symptomatic dermographism patients at 12 weeks, indicating its potential to improve patient quality of life, especially in the absence of effective treatment options.
- Addressing Patient Needs: With over 533,000 patients affected by cold urticaria and symptomatic dermographism in the U.S. and Europe, and existing treatments proving inadequate, the development of barzolvolimab offers new hope for these patients, potentially leading to significant improvements in their quality of life and mental health.
- Future Outlook: As barzolvolimab advances across multiple indications, Celldex demonstrates its innovative capabilities in immunology, with expectations to provide more effective treatment options for patients, further solidifying its leadership position in the biopharmaceutical industry.
See More
Cleveland Diagnostics' IsoPSA Receives FDA Approval, Enhancing Prostate Biopsy Decision-Making
- FDA Approval Milestone: Cleveland Diagnostics' IsoPSA® in vitro diagnostic kit has received FDA approval through the Premarket Approval process, marking a significant advancement in early cancer detection and is expected to greatly enhance physician confidence in prostate biopsy decision-making.
- Clinical Research Support: The FDA approval of IsoPSA is based on robust clinical evidence from a large-scale prospective study conducted at 14 sites across the U.S., addressing the diagnostic gap where over 1 million men undergo prostate biopsies annually, yet only 25% yield positive results for high-grade disease.
- Cost Reduction in Healthcare: By providing more accurate risk assessments, IsoPSA helps reduce unnecessary invasive procedures and associated healthcare costs, which is anticipated to alleviate physical risks and emotional stress for patients, thereby improving the overall healthcare experience.
- Market Access Expansion: Since its introduction as a Laboratory-Developed Test (LDT) in 2020, IsoPSA has gained coverage from Medicare and an increasing number of commercial payors, further driving its application in clinical practice and enhancing patient accessibility.
See More
