Celldex Therapeutics, Inc. (NASDAQ:CLDX) is one of the best small cap stocks to buy with huge upside potential. Barclays lifted the price target on Celldex Therapeutics, Inc. (NASDAQ:CLDX) to $24 from $21 on December 17 and reaffirmed an Equal Weight rating on the stock. The firm told investors that it adjusted the price targets in the biotechnology space to take into account its 2026 outlook. Is Celldex Therapeutics, Inc. (CLDX) the Best Cancer Stock to Invest in for Long-Term Gain? In a separate develo ...

Core Insights - Celldex has initiated a global Phase 3 trial (EMBARQ-ColdU and SD) to evaluate the efficacy and safety of barzolvolimab in adult patients with cold urticaria (ColdU) and symptomatic dermographism (SD) who are symptomatic despite H1 antihistamine treatment [1][2] - Barzolvolimab is a humanized monoclonal antibody that targets the receptor tyrosine kinase KIT, crucial for mast cell function, which is a key driver in ColdU and SD [1][7] - The trial aims to enroll approximately 240 participants across 75 clinical sites in 7 countries, with a primary endpoint focused on the percentage of patients achieving a complete response at Week 12 [2][3] Study Design and Objectives - The EMBARQ-ColdU and SD trial will include two cohorts: one for ColdU and one for SD, with participants randomized in a 1:1 ratio to receive either barzolvolimab or placebo for 24 weeks [2][3] - The primary endpoint will assess the complete response rate using TempTest® for ColdU and FricTest® for SD at Week 12, with follow-up for 16 weeks post-treatment [2][5] Clinical Background and Need - ColdU and SD affect over 533,000 patients in the U.S. and Europe, with no advanced therapies currently approved, leading to inadequate disease control for over 80% of patients [3][4] - Patients often experience severe itching and hives, significantly impacting their mental and emotional well-being, daily activities, and social interactions [3][4] Previous Study Results - A Phase 2 study showed that barzolvolimab met its primary endpoint, demonstrating a statistically significant difference in negative provocation tests compared to placebo at Week 12, with up to 75% of ColdU patients and 67% of SD patients achieving a partial or complete response [3][5] - Secondary endpoints also showed strong support for the primary results, with sustained effects through the end of the treatment period [5] Future Directions - Barzolvolimab is being studied across five indications, including chronic spontaneous urticaria, with ongoing Phase 3 studies and plans for additional indications [3][7] - The initiation of the EMBARQ-ColdU and SD trial represents a significant advancement in treatment options for patients suffering from these conditions [4][5]

Core Insights - Celldex reported financial results for Q3 2025, highlighting advancements in its pipeline, particularly with barzolvolimab, which has shown clinical benefits in treating cold urticaria and symptomatic dermographism [1][2] Financial Performance - Cash Position: As of September 30, 2025, cash, cash equivalents, and marketable securities totaled $583.2 million, down from $630.3 million as of June 30, 2025, primarily due to $48.6 million used in operating activities during Q3 [13] - Revenues: Total revenue was $0.0 million for Q3 2025 and $1.4 million for the nine months ended September 30, 2025, compared to $3.2 million and $5.8 million for the same periods in 2024, reflecting a decrease due to reduced services under manufacturing and R&D agreements [14] - R&D Expenses: R&D expenses were $62.9 million for Q3 2025 and $169.7 million for the nine months ended September 30, 2025, up from $45.3 million and $116.6 million in 2024, attributed to increased clinical trial costs for barzolvolimab [15] - G&A Expenses: G&A expenses were $10.7 million for Q3 2025 and $31.9 million for the nine months ended September 30, 2025, compared to $10.1 million and $28.3 million in 2024, mainly due to higher stock-based compensation and employee headcount [16] - Net Loss: The net loss was $67.0 million, or ($1.01) per share, for Q3 2025, and $177.4 million, or ($2.67) per share, for the nine months ended September 30, 2025, compared to a net loss of $42.1 million, or ($0.64) per share, for Q3 2024 [17] Pipeline Developments - Barzolvolimab: This humanized monoclonal antibody has shown significant efficacy in treating chronic spontaneous urticaria (CSU) and cold urticaria, with 71% of patients achieving a complete response at 52 weeks in the Phase 2 CSU study [5][6] - Upcoming Studies: A global Phase 3 study for cold urticaria and symptomatic dermographism is set to begin in December 2025, following positive Phase 2 results [7] - CDX-622: The first stem cell factor neutralizing bispecific antibody studied in humans, showing promising Phase 1 data with a favorable safety profile [10][12] Corporate Updates - Leadership: Teri Lawver has joined Celldex as Senior Vice President, Chief Commercial Officer, bringing extensive experience in launching immunology drugs, which is expected to aid in the commercialization of barzolvolimab [2]

HAMPTON, N.J., Nov. 06, 2025 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) announced today 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). The data (presentation #R080) are being presented at the American College of Allergy, Asthma & Immunology's Annual Scientific Meeting (ACAAI) in Orlando, Florida by Dr. Steven Greenberg, Vice President of Clinical Sci ...

Core Viewpoint - Celldex Therapeutics, Inc. (NASDAQ:CLDX) is viewed as a small-cap stock with potential upside, but Barclays has initiated coverage with an Underweight rating and a $25 price target due to safety concerns and competitive pressures [1][3]. Group 1: Company Overview - Celldex Therapeutics, Inc. develops, manufactures, and commercializes novel therapeutics for human health care, with a pipeline that includes Varlilumab, CDX-1140, CDX-301, and CDX-3379 [3]. Group 2: Investment Analysis - Barclays highlighted that while there is binary risk associated with small and mid-cap biotechnology stocks, investments backed by de-risked mechanisms of action and prior clinical data present a favorable risk-reward profile [2]. - The firm noted that the market is currently favorable towards new mechanisms and modes of action that could enhance dosing frequency and patient compliance [2]. Group 3: Clinical Data and Market Position - Despite the encouraging clinical data for Celldex's lead molecule barzolvolimab, the shares are not expected to provide significant upside through 2026 due to safety liabilities and a competitive landscape [3].

Group 1 - Celldex Therapeutics, Inc. (NASDAQ: CLDX) shares have increased over 70% from their 60-month low in April 2025, which was attributed to high discontinuation rates for their lead asset, barzolvolimab [2] - The company is involved in mast cell therapy and has faced challenges with its primary asset, impacting its stock performance [2] - The Biotech Forum offers a model portfolio featuring 12-20 high upside biotech stocks, along with live discussions and weekly updates [2]

Core Insights - Celldex Therapeutics, Inc. announced topline results from its Phase 2 study of barzolvolimab for eosinophilic esophagitis (EoE), meeting the primary endpoint of mast cell depletion but failing to show clinical improvement in symptoms [1][2][6] Study Results - The study aimed to assess the effect of barzolvolimab on intraepithelial mast cells and clinical outcomes in EoE [1] - The primary endpoint was met with a significant reduction in peak esophageal intraepithelial mast cell count, showing an absolute change from baseline of -36.0 for barzolvolimab compared to -2.7 for placebo at Week 12 [5][6] - Despite the significant mast cell depletion, no improvement in EoE symptoms was observed, with p-values of 0.33 for the Dysphagia Symptom Questionnaire and 0.95 for endoscopic scoring [6][7] Safety Profile - Barzolvolimab exhibited a favorable safety and tolerability profile consistent with previous studies [2][7] - The dosing regimen of 300 mg Q4W was well-tolerated, showing no significant adverse effects compared to less frequent dosing in earlier studies [7] Future Directions - Following these results, Celldex will not pursue further development of barzolvolimab for EoE but will continue to advance its pipeline, including ongoing studies in chronic spontaneous urticaria and plans for a Phase 3 program in inducible urticaria [3][4]

Core Insights - Celldex Therapeutics reported topline results from a Phase 2 study of barzolvolimab in eosinophilic esophagitis (EoE), indicating that while the primary endpoint of mast cell depletion was met, there was no improvement in EoE symptoms or endoscopic assessments compared to placebo [1][4][5] - The company will not pursue further development of barzolvolimab for EoE but will continue to explore its potential in other gastrointestinal indications [1][2] Study Design and Results - The Phase 2 study was a randomized, double-blind, placebo-controlled trial involving 65 patients with moderate to severe EoE, assessing the efficacy and safety of subcutaneous barzolvolimab [4][6] - The primary endpoint was the reduction in peak esophageal intraepithelial mast cell count at 12 weeks, which was achieved with a significant reduction of -36.0 in the barzolvolimab group compared to -2.7 in the placebo group (p=<0.0001) [5][6] - Despite the significant mast cell depletion, no clinical improvement was observed in EoE symptoms (p=0.33) or endoscopic scoring (p=0.95) [5][6] Safety Profile - Barzolvolimab demonstrated a favorable safety profile at the 300 mg Q4 weekly dosing regimen, consistent with previous studies [5][6] - An unblinded review of data through the full treatment period (28 weeks) showed consistent clinical and safety outcomes [5] Future Development Plans - Celldex is focusing on advancing barzolvolimab's pipeline, with ongoing enrollment in four studies, including two Phase 3 studies in chronic spontaneous urticaria and Phase 2 studies in atopic dermatitis and prurigo nodularis [2][8] - Plans are also being finalized to initiate a Phase 3 program in inducible urticaria, which will include cold urticaria and symptomatic dermographism [2][8]

Core Insights - Celldex Therapeutics announced that barzolvolimab significantly improves angioedema in chronic spontaneous urticaria (CSU) patients after 52 weeks of treatment [1][2][3] Group 1: Clinical Trial Results - The Phase 2 clinical trial met primary and secondary endpoints at 12 weeks, showing significant decreases in UAS7 scores compared to placebo [2][5] - At Week 52, an 86% mean reduction in angioedema activity was reported for the 150 mg Q4W group, and an 82% reduction for the 300 mg Q8W group [6] - 77% of patients treated with barzolvolimab who had angioedema at baseline were angioedema-free at Week 52 [5][6] Group 2: Patient Impact - The majority of patients with severe CSU experience painful angioedema, which significantly affects their quality of life [3][6] - 87% of patients reported clinically meaningful improvement in angioedema activity scores at Week 52 [6] Group 3: Drug Mechanism and Future Studies - Barzolvolimab is a humanized monoclonal antibody that targets the receptor tyrosine kinase KIT, which is involved in mast cell activation [4] - Celldex is conducting a global Phase 3 program for barzolvolimab in CSU, with enrollment currently underway [8]

Core Insights - Celldex announced new data showing significant and sustained complete response in chronic spontaneous urticaria (CSU) patients treated with barzolvolimab, with improvements in quality of life observed at 76 weeks post-treatment [1][2][3] Efficacy Data - The Phase 2 study met its primary endpoint, showing a significant improvement in UAS7 (weekly urticaria activity score) compared to placebo at 12 weeks across all dose groups [2][11] - At 12 weeks, up to 51% of patients achieved a complete response (UAS7=0), which increased to 71% at 52 weeks, and 41% maintained this response at 76 weeks [2][6] - 48% of patients reported that CSU no longer impacted their quality of life at 76 weeks, as measured by the Dermatology Life Quality Index (DLQI) [5][6] Safety Profile - Barzolvolimab demonstrated a well-tolerated safety profile throughout the study, with the most common adverse events being mild and reversible [7][3] - No new safety signals were identified, and neutropenia events resolved rapidly without association to infections [7][3] Future Developments - Enrollment for Phase 3 trials of barzolvolimab in CSU is ongoing, with two global Phase 3 trials designed to establish efficacy and safety in patients who remain symptomatic despite antihistamine treatment [12][11] - The company is focused on executing clinical trials to bring this potential new treatment to patients suffering from CSU [8][14]