Celldex Completes Enrollment in Phase 3 Trials for Chronic Spontaneous Urticaria
Written by Emily J. Thompson, Senior Investment Analyst
Updated: 1 day ago
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Should l Buy CLDX?
Celldex announced the completion of enrollment in the Company's global Phase 3 program of barzolvolimab in chronic spontaneous urticaria, which consists of two Phase 3 trials-EMBARQ-CSU1 and EMBARQ-CSU2. "Completing enrollment in these large Phase 3 CSU studies 6 months ahead of guidance highlights the significant unmet need in CSU and speaks to the excitement from patients and physicians about barzolvolimab and its potential as a best-in-disease treatment," said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex. "We are extremely grateful to these patients, their families and their treating physicians for their enthusiasm and participation in the EMBARQ-CSU1 and EMBARQ-CSU2 studies. We look forward to reporting topline results later this year and remain focused on completing preparations to support bringing this much needed treatment to more than 1.8 million patients in the United States suffering from 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: 30.820
Low
24.00
Averages
55.00
High
90.00
Current: 30.820
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.
Celldex Completes Enrollment for Barzolvolimab Trial Ahead of Schedule
- Enrollment Completion: Celldex announced the completion of enrollment for its large-scale Chronic Spontaneous Urticaria (CSU) clinical trial six months ahead of schedule, with 1,939 patients enrolled, highlighting the significant unmet need in this area, with data expected in Q4 2026.
- Regulatory Submission Plans: The company plans to submit an application for barzolvolimab approval to the U.S. FDA in 2027 based on clinical trial data, aiming to establish its efficacy and safety in CSU patients, which could facilitate market entry.
- Positive Market Sentiment: On Stocktwits, retail sentiment around CLDX stock remains in the 'bullish' territory, with users optimistic about the drug's annual sales potential, projecting the company's market capitalization to rise to $25 billion, indicating strong investor confidence in the drug's prospects.
- Analyst Ratings Optimistic: According to Koyfin data, the average price target for CLDX is $53.36, representing a potential upside of about 73% from current trading levels, with 13 out of 16 analysts rating it 'Buy' or higher, reflecting a positive outlook for the stock.
See More
Celldex Q4 Earnings Miss Expectations
- Disappointing Earnings: Celldex reported a Q4 GAAP EPS of -$1.22, missing expectations by $0.20, indicating ongoing challenges in profitability that may affect investor confidence.
- Significant Revenue Decline: The company generated only $0.12M in revenue for Q4, a staggering 89.8% year-over-year drop, falling short of the anticipated $1.34M, reflecting a notable weakness in product sales that could increase future cash flow pressures.
- Decreased Cash Reserves: As of December 31, 2025, Celldex's cash, cash equivalents, and marketable securities totaled $518.6M, down from $583.2M as of September 30, 2025, highlighting challenges in cash management that may impact its R&D and operational capabilities.
- Clinical Trial Progress: Despite the poor financial performance, Celldex has completed enrollments in late-stage trials for its lead asset, potentially paving the way for future product launches, although short-term financial pressures remain.
See More
Celldex Completes Enrollment in Chronic Spontaneous Urticaria Studies Ahead of Schedule
- Rapid Research Progress: Celldex completed enrollment in its global chronic spontaneous urticaria (CSU) registration studies six months ahead of schedule, enrolling 1,939 patients, which reflects strong interest in barzolvolimab, with topline data expected in Q4 2026 to support a planned BLA submission in 2027.
- New Drug Development Outlook: The company is actively accruing patients in its Phase 3 studies for cold urticaria and symptomatic dermographism (EMBARQ-ColdU and -SD), where barzolvolimab has demonstrated clinical benefits in a large randomized controlled trial, further solidifying its leadership in immunology.
- Financial Position Analysis: As of December 31, 2025, Celldex reported cash and cash equivalents of $518.6 million, down from $583.2 million as of September 30, 2025, primarily due to increased operating expenses in the fourth quarter, indicating the company's commitment to accelerating clinical trials.
- Future Prospects: Celldex anticipates multiple important data readouts in 2026, including topline data from CSU and other indications, marking the company's ongoing efforts to drive innovative treatment solutions that could transform the treatment landscape and enhance its competitive position in the market.
See More
Update: Celldex Therapeutics Completes Enrollment in Phase 3 Studies of Barzolvolimab; Shares Rise
See More
Celldex Therapeutics Shares Surge 18% on Early Enrollment Completion
- Early Enrollment Completion: Celldex Therapeutics announced that enrollment for its Phase 3 clinical trial targeting chronic spontaneous urticaria concluded six months ahead of schedule, significantly enhancing the company's competitive position in the biopharmaceutical sector.
- Clinical Trial Scale: The program includes two Phase 3 trials, EMBARQ-CSU1 and EMBARQ-CSU2, planned to be conducted at over 500 study sites across 43 countries, showcasing Celldex's extensive global reach and resource integration capabilities.
- Data Release Expectations: Celldex anticipates topline data to be released in Q4 2026, and the early completion of this timeline may expedite the FDA's market application process, potentially leading to revenue growth for the company.
- Market Application Plans: The company plans to submit a marketing application for barzolvolimab to the FDA next year, and if approved, this could open new revenue streams for Celldex, further solidifying its leadership in the chronic spontaneous urticaria treatment space.
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 Completes Enrollment for Barzolvolimab Trial Ahead of Schedule
- Enrollment Completion: Celldex announced the completion of enrollment for its large-scale Chronic Spontaneous Urticaria (CSU) clinical trial six months ahead of schedule, with 1,939 patients enrolled, highlighting the significant unmet need in this area, with data expected in Q4 2026.
- Regulatory Submission Plans: The company plans to submit an application for barzolvolimab approval to the U.S. FDA in 2027 based on clinical trial data, aiming to establish its efficacy and safety in CSU patients, which could facilitate market entry.
- Positive Market Sentiment: On Stocktwits, retail sentiment around CLDX stock remains in the 'bullish' territory, with users optimistic about the drug's annual sales potential, projecting the company's market capitalization to rise to $25 billion, indicating strong investor confidence in the drug's prospects.
- Analyst Ratings Optimistic: According to Koyfin data, the average price target for CLDX is $53.36, representing a potential upside of about 73% from current trading levels, with 13 out of 16 analysts rating it 'Buy' or higher, reflecting a positive outlook for the stock.
See More
Celldex Q4 Earnings Miss Expectations
- Disappointing Earnings: Celldex reported a Q4 GAAP EPS of -$1.22, missing expectations by $0.20, indicating ongoing challenges in profitability that may affect investor confidence.
- Significant Revenue Decline: The company generated only $0.12M in revenue for Q4, a staggering 89.8% year-over-year drop, falling short of the anticipated $1.34M, reflecting a notable weakness in product sales that could increase future cash flow pressures.
- Decreased Cash Reserves: As of December 31, 2025, Celldex's cash, cash equivalents, and marketable securities totaled $518.6M, down from $583.2M as of September 30, 2025, highlighting challenges in cash management that may impact its R&D and operational capabilities.
- Clinical Trial Progress: Despite the poor financial performance, Celldex has completed enrollments in late-stage trials for its lead asset, potentially paving the way for future product launches, although short-term financial pressures remain.
See More
Celldex Completes Enrollment in Chronic Spontaneous Urticaria Studies Ahead of Schedule
- Rapid Research Progress: Celldex completed enrollment in its global chronic spontaneous urticaria (CSU) registration studies six months ahead of schedule, enrolling 1,939 patients, which reflects strong interest in barzolvolimab, with topline data expected in Q4 2026 to support a planned BLA submission in 2027.
- New Drug Development Outlook: The company is actively accruing patients in its Phase 3 studies for cold urticaria and symptomatic dermographism (EMBARQ-ColdU and -SD), where barzolvolimab has demonstrated clinical benefits in a large randomized controlled trial, further solidifying its leadership in immunology.
- Financial Position Analysis: As of December 31, 2025, Celldex reported cash and cash equivalents of $518.6 million, down from $583.2 million as of September 30, 2025, primarily due to increased operating expenses in the fourth quarter, indicating the company's commitment to accelerating clinical trials.
- Future Prospects: Celldex anticipates multiple important data readouts in 2026, including topline data from CSU and other indications, marking the company's ongoing efforts to drive innovative treatment solutions that could transform the treatment landscape and enhance its competitive position in the market.
See More
Update: Celldex Therapeutics Completes Enrollment in Phase 3 Studies of Barzolvolimab; Shares Rise
See More
Celldex Therapeutics Shares Surge 18% on Early Enrollment Completion
- Early Enrollment Completion: Celldex Therapeutics announced that enrollment for its Phase 3 clinical trial targeting chronic spontaneous urticaria concluded six months ahead of schedule, significantly enhancing the company's competitive position in the biopharmaceutical sector.
- Clinical Trial Scale: The program includes two Phase 3 trials, EMBARQ-CSU1 and EMBARQ-CSU2, planned to be conducted at over 500 study sites across 43 countries, showcasing Celldex's extensive global reach and resource integration capabilities.
- Data Release Expectations: Celldex anticipates topline data to be released in Q4 2026, and the early completion of this timeline may expedite the FDA's market application process, potentially leading to revenue growth for the company.
- Market Application Plans: The company plans to submit a marketing application for barzolvolimab to the FDA next year, and if approved, this could open new revenue streams for Celldex, further solidifying its leadership in the chronic spontaneous urticaria treatment space.
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
