#CLDX

StockTitan

@stocktitan.net

3 months ago

Celldex Initiates Global Registrational Phase 3 Program of Barzolvolimab in Cold Urticaria and Symptomatic Dermographism No advanced therapies approved to treat ColdU and SD—diseases of misery that dramatically impact all aspects of patient life Barzolvolimab is the only drug in development to demonstrate clinical benefit in patients in ColdU and SD in a large, randomized, placebo-controlled study--all primary and

#CLDX Celldex Initiates Global Registrational Phase 3 Program of Barzolvolimab in Cold Urticaria and Symptomatic Dermographism

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StockTitan

@stocktitan.net

4 months ago

Celldex Reports Third Quarter 2025 Financial Results and Provides Corporate Update Celldex (NASDAQ:CLDX) reported Q3 2025 results and pipeline progress on Nov 10, 2025. Key clinical wins include positive Phase 2 barzolvolimab data in CSU (71% complete response at 52 weeks; >40% sustained at 76 weeks), positive Phase 2 results in ColdU and SD (complete response up to 66% and 49% vs placebo 16% and 10% at 20 weeks), and Phase 3 for ColdU/SD planned to start in Dec 2025. CDX-622 Phase 1 showed good tolerability, favorable PK, and dose-dependent serum tryptase reductions; Part 2 data expected Q3 2026. Financials: cash and marketable securities were $583.2M at Sept 30, 2025, net loss was $67.0M (Q3) and R&D spend was $62.9M (Q3). Company expects runway through 2027.

#CLDX Celldex Reports Third Quarter 2025 Financial Results and Provides Corporate Update

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StockTitan

@stocktitan.net

4 months ago

Celldex Announces Initial Positive Results from Phase 1 Trial of CDX-622 Demonstrating Favorable Safety and PK Profile and Sustained Mast Cell Inhibition Celldex (NASDAQ:CLDX) reported positive Phase 1 data for CDX-622, a bispecific antibody targeting stem cell factor (SCF) and thymic stromal lymphopoietin (TSLP), presented Oct 30, 2025.Key results: well tolerated in 32 healthy participants across 4 IV dose cohorts (0.3–9.0 mg/kg), no dose-limiting toxicities, no serious adverse events, no antidrug antibodies, mAb-like PK with ~18-day half-life at 9 mg/kg, and a ~50% sustained reduction in serum tryptase over 12 weeks after a single dose. NOAEL in GLP tox was the highest tested dose (75 mg/kg) with profound tissue mast cell depletion. Company advanced to multiple ascending doses and plans to report Parts 2/3 data in Q3 2026 and initiate a Phase 1b asthma study thereafter.

#CLDX Celldex Announces Initial Positive Results from Phase 1 Trial of CDX-622 Demonstrating Favorable Safety and PK Profile and Sustained Mast Cell Inhibition

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StockTitan

@stocktitan.net

6 months ago

Celldex Reports Results from Phase 2 Study of Barzolvolimab in Eosinophilic Esophagitis (EoE) Celldex Therapeutics (NASDAQ:CLDX) announced topline results from its Phase 2 study of barzolvolimab in eosinophilic esophagitis (EoE). While the study met its primary endpoint by demonstrating significant mast cell depletion in the gastrointestinal tract, it failed to show clinical improvement in EoE symptoms compared to placebo.The trial showed that peak mast cell counts decreased by 36.0 in the barzolvolimab arm versus 2.7 in placebo (pCelldex will not advance development in EoE but continues to progress barzolvolimab in other indications, including two Phase 3 studies in chronic spontaneous urticaria and Phase 2 studies in atopic dermatitis and prurigo nodularis.

#CLDX Celldex Reports Results from Phase 2 Study of Barzolvolimab in Eosinophilic Esophagitis (EoE)

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StockTitan

@stocktitan.net

7 months ago

Celldex Reports Second Quarter 2025 Financial Results and Provides Corporate Update Celldex Therapeutics (NASDAQ:CLDX) reported Q2 2025 financial results and pipeline updates. The company's lead drug barzolvolimab demonstrated exceptional results in Phase 2 chronic spontaneous urticaria (CSU) studies, with up to 41% of patients maintaining complete response 7 months after treatment completion.Financial highlights include $630.3 million in cash reserves (sufficient through 2027), Q2 net loss of $56.6 million ($0.85 per share), and increased R&D expenses of $54.2 million. The company is advancing its global Phase 3 program in CSU with two trials enrolling approximately 915 patients each.Multiple data readouts are expected in 2H 2025, including results from Phase 2 studies in eosinophilic esophagitis (EoE) and chronic inducible urticaria (CIndU), along with Phase 1 data from CDX-622 in healthy volunteers.

#CLDX Celldex Reports Second Quarter 2025 Financial Results and Provides Corporate Update

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StockTitan

@stocktitan.net

9 months ago

Celldex Presents Data Demonstrating Profound Long Term Improvement in Angioedema in Barzolvolimab Phase 2 Study in Chronic Spontaneous Urticaria at EAACI 2025 Celldex Therapeutics (NASDAQ:CLDX) presented positive 52-week data from their Phase 2 trial of barzolvolimab in chronic spontaneous urticaria (CSU) at EAACI 2025. The study showed remarkable improvements in angioedema symptoms, with 77% of patients in the 150 mg Q4W group becoming angioedema-free at Week 52. The drug demonstrated an 86% mean reduction from baseline in the 150 mg Q4W arm and 82% reduction in the 300 mg Q8W arm. The trial, which previously met its primary and secondary endpoints at 12 weeks, showed patients were angioedema-free up to 72% of the time over the 52-week treatment period. Up to 87% of patients reported clinically meaningful improvement in AAS7 scores at Week 52. The study population had severe CSU, with over 70% of patients having a UAS7 score greater than 28 at baseline.

#CLDX Celldex Presents Data Demonstrating Profound Long Term Improvement in Angioedema in Barzolvolimab Phase 2 Study in Chronic Spontaneous Urticaria at EAACI 2025

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StockTitan

@stocktitan.net

9 months ago

Celldex Presents Unprecedented 76 Week Results from Barzolvolimab Phase 2 Study in Chronic Spontaneous Urticaria at EAACI Congress 2025 Celldex (NASDAQ:CLDX) announced groundbreaking 76-week results for barzolvolimab in treating chronic spontaneous urticaria (CSU). The Phase 2 study showed remarkable sustained benefits 7 months after treatment completion, with 41% of patients on 150 mg Q4W maintaining complete response (UAS7=0) and 48% reporting no quality of life impact. The drug, which targets mast cells through KIT receptor inhibition, demonstrated rapid efficacy across all dose groups, with improvements visible within one week. The study met its primary endpoint with significant UAS7 improvements versus placebo at 12 weeks. Notably, the treatment showed robust efficacy regardless of prior omalizumab experience and maintained a favorable safety profile, with most adverse events being mild and reversible. The company is currently conducting Phase 3 trials, positioning barzolvolimab as a potential transformative treatment for CSU patients.

#CLDX Celldex Presents Unprecedented 76 Week Results from Barzolvolimab Phase 2 Study in Chronic Spontaneous Urticaria at EAACI Congress 2025

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StockTitan

@stocktitan.net

10 months ago

Celldex Reports First Quarter 2025 Financial Results and Provides Corporate Update Celldex Therapeutics (NASDAQ:CLDX) reported Q1 2025 financial results and pipeline updates. The company's lead drug barzolvolimab showed promising results in Phase 2 studies for chronic urticaria, with significant quality of life improvements for patients. Key highlights include: - Two Phase 3 trials (EMBARQ-CSU1 and EMBARQ-CSU2) for chronic spontaneous urticaria are ongoing, each enrolling ~915 patients - 76-week data from Phase 2 CSU study will be presented at EAACI 2025 in June - Phase 2 studies in eosinophilic esophagitis (enrollment complete), prurigo nodularis, and atopic dermatitis are progressing Financial results: Q1 2025 net loss of $53.8M ($0.81/share), cash position of $673.3M. R&D expenses increased to $52.6M from $31.7M YoY. Current cash runway extends through 2027.

#CLDX Celldex Reports First Quarter 2025 Financial Results and Provides Corporate Update

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StockTitan

@stocktitan.net

10 months ago

Celldex Presents Histology Data from Phase 2 Study of Barzolvolimab in EoE Supporting Potential of Mast Depleting Agent in this Difficult to Treat Disease Celldex presented histology data from its ongoing Phase 2 study of barzolvolimab in treating eosinophilic esophagitis (EoE) at DDW 2025. The data revealed high numbers of intraepithelial mast cells in EoE patients, correlating with eosinophil counts. This supports the potential therapeutic benefit of barzolvolimab as a mast cell depleting agent. The Phase 2 "EvolvE" study is fully enrolled, with clinical results expected in 2H 2025. The trial involves a 28-week, randomized, double-blind study evaluating 300 mg of barzolvolimab versus placebo administered every 4 weeks. The primary endpoint focuses on reduction in peak esophageal epithelial mast cell count at 12 weeks. Screening data from 151 participants showed strong associations between mast cells and eosinophils, particularly in the distal esophagus, supporting the drug's potential in treating this chronic inflammatory disease.

#CLDX Celldex Presents Histology Data from Phase 2 Study of Barzolvolimab in EoE Supporting Potential of Mast Depleting Agent in this Difficult to Treat Disease

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StockTitan

@stocktitan.net

1 year ago

Can Celldex's Dual-Mechanism CDX-622 Transform Inflammatory Disease Treatment? Novel bispecific antibody demonstrates effective neutralization of both SCF and TSLP pathways with clean safety profile. Phase 1 trial now underway with data expected in 2025.

#CLDX Celldex Therapeutics Presents Positive Preclinical Data from Inflammatory Bispecific Antibody Program CDX-622 at AAAAI 2025

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Market Wire News

@marketwirenews.com

1 year ago

NEWS: ( NASDAQ: #CLDX ) Celldex Therapeutics Presents Positive Results from Barzolvolimab Phase 2 Studies in Patients with Chronic Urticaria Demonstrating Improved Disease Control and Quality of Life at AAAAI 2025

StockTitan

@stocktitan.net

1 year ago

Celldex Reports Fourth Quarter and Year End 2024 Financial Results and Provides Corporate Update Celldex Therapeutics (NASDAQ:CLDX) reported its Q4 and full-year 2024 financial results, highlighting significant progress in its clinical programs. The company's lead drug barzolvolimab showed promising results in chronic urticarias, with Phase 3 studies actively enrolling patients globally.Financial highlights include: Cash position of $725.3 million as of December 31, 2024Q4 2024 revenue of $1.2 millionFull-year 2024 revenue of $7.0 millionQ4 net loss of $47.1 million ($0.71 per share)Full-year net loss of $157.9 million ($2.45 per share)The company initiated new programs including a Phase 2 study in atopic dermatitis and launched CDX-622, their first inflammatory bispecific candidate. Multiple data readouts are expected in 2025, with current cash runway extending through 2027.

#CLDX Celldex Reports Fourth Quarter and Year End 2024 Financial Results and Provides Corporate Update

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Gilbert Gerber

@giger1964.bsky.social

1 year ago

Clearly cKIt (CD117) is not the right target to go after in CSU ! After Celldex #CLDX mAb in 09/24, Jasper #JSPR mAb in 01/25, today it's Third Harmonic #THRD small molecule to take the plunge. Enanta #ENTA SME is still preclinical. Inflarx #IFRX anti C5aR looks all the more promissing (Precli+ph1)

StockTitan

@stocktitan.net

1 year ago

Celldex Launches Pivotal Phase 2 Trial for Novel Atopic Dermatitis Treatment, Targeting 20% of US Population Celldex advances barzolvolimab into Phase 2 study for moderate to severe atopic dermatitis, exploring potential breakthrough therapy for millions of US patients.

#CLDX Celldex Initiates Phase 2 Study of Barzolvolimab in Atopic Dermatitis

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StockTitan

@stocktitan.net

1 year ago

#CLDX Celldex Announces First Patient Dosed in Phase 1 Healthy Volunteer Study of CDX-622, a Bispecific Antibody, for the Treatment of Inflammatory Diseases

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Market Wire News

@marketwirenews.com

1 year ago

Just In: ( NASDAQ: #CLDX ) Neutral Recommendation Issued On CLDX By Goldman Sachs

#StockMarket #News