Celldex Therapeutics (CLDX) Company Report

Celldex has initiated a global Phase 3 trial (EMBARQ-ColdU and SD) for its drug barzolvolimab in adult patients with cold urticaria (ColdU) and symptomatic dermographism (SD).
Barzolvolimab is a humanized monoclonal antibody that targets KIT, inhibiting mast cell activity, which is a critical driver of ColdU and SD.
There are no advanced therapies approved to treat ColdU and SD, conditions that impact over 533,000 patients across the United States and Europe.
In a prior Phase 2 study, barzolvolimab demonstrated significant clinical benefit, meeting all primary and secondary endpoints with rapid, sustained, and complete disease responses.
This marks the second Phase 3 program for barzolvolimab, with another ongoing for chronic spontaneous urticaria (CSU).

Dec 9, 2025, 1:01 PM

Press Release

Celldex Therapeutics Provides Pipeline and Commercial Strategy Update

CLDX

New Projects/Investments

Guidance Update

Product Launch

Celldex Therapeutics is a late-stage company with its Barzal program in Phase 3 development for Chronic Spontaneous Urticaria (CSU), expecting accrual completion by July 2026, and plans to initiate a Phase 3 study for its CIndU program by the end of December 2025.
The company anticipates 2026 to be a significant year with Phase 2 readouts for Barzal in prurigo nodularis and atopic dermatitis, and Multiple Ascending Dose (MAD) data for its bispecific program CDX-622 expected in Q3 2026.
Management projects Barzal's pricing to be much higher than $40,000 a year, potentially exceeding $59,000, and is considering partnerships for ex-US markets while potentially handling the US launch internally.

Dec 2, 2025, 8:00 PM

Transcript

Celldex Therapeutics Provides Clinical Pipeline and Commercial Strategy Update

CLDX

New Projects/Investments

Product Launch

Guidance Update

Celldex Therapeutics concluded 2025 as a late-stage company with its CSU program in Phase 3 development and plans to initiate a Phase 3 in its CIndU program by the end of December 2025.
Key milestones for 2026 include the expected completion of accrual for the Phase 3 CSU study by July 2026, along with Phase 2 readouts for prurigo nodularis and atopic dermatitis.
The CDX-622 bispecific program has completed its single ascending dose study, is currently accruing the multiple ascending dose (MAD) study, and expects MAD data in Q3 2026. A sub-Q single ascending dose study will also read out in 2026, and a proof of mechanism study in severe asthma will commence.
For Barzolana, the company anticipates pricing to be significantly higher than $40,000 per year, potentially exceeding $59,000, and estimates the target CSU patient population to be 40% higher than the 80,000 patients currently on OMA in the U.S..
Celldex is considering partnership opportunities for Barzolana outside the U.S. but intends to commercialize it themselves in the U.S., while also exploring additional indications for Barzolana such as food allergy and allergic rhinitis.

Dec 2, 2025, 8:00 PM

Transcript

Celldex Discusses Barzolvolimab Durability and 2026 Pipeline Catalysts

CLDX

New Projects/Investments

Guidance Update

Celldex reported unprecedented 41% complete response rate in 76-week Phase 2 data for Barzolvolimab in Chronic Spontaneous Urticaria (CSU), seven months after treatment cessation, indicating durable remission.
Accrual for the Barzolvolimab CSU Phase 3 studies is expected to conclude by summer 2026.
The company anticipates significant data readouts in the second half of 2026, including Phase 2 results for Barzolvolimab in Prurigo Nodularis (PN) and Atopic Dermatitis (AD), alongside CDX-622 multiple ascending dose (MAD) data.
CDX-622, a bispecific targeting stem cell factor and TSLP, demonstrated an 18-day half-life and no immunogenicity in Phase 1 healthy volunteer data, with plans for further development in asthma and other inflammatory diseases.

Nov 13, 2025, 2:30 PM

Transcript

Celldex Highlights Strong Barzolumab Durability in CSU and Outlines Multiple 2026 Catalysts

CLDX

New Projects/Investments

Guidance Update

Celldex reported unprecedented Phase 2 data for barzolumab (CDX-0159) in Chronic Spontaneous Urticaria (CSU), demonstrating a 41% complete response rate seven months after stopping treatment, which suggests potential disease modification.
The company anticipates several key data readouts in 2026, including Phase 2 results for barzolumab in Prurigo Nodularis (PN) and Atopic Dermatitis (AD), as well as multiple ascending dose (MAD) data for CDX-0622.
Enrollment for the barzolumab Phase 3 studies in CSU (EMBARK CSU one and CSU two) is progressing well, with accrual expected to be completed by summer 2026.
CDX-0622, a bispecific antibody targeting stem cell factor and TSLP, demonstrated an 18-day half-life in healthy volunteers and is being explored for mild to moderate asthma and other pulmonary or allergic indications.

Nov 13, 2025, 2:30 PM

Transcript

Celldex Therapeutics Provides Updates on Urticaria Programs, CDX-622, and Financial Runway

CLDX

New Projects/Investments

Guidance Update

Celldex Therapeutics reported phenomenal efficacy from its 76-week data in the Chronic Spontaneous Urticaria (CSU) program, including a 41% complete response rate seven months post-treatment, which is considered unprecedented.
The company presented positive data from its Phase 2 inducible urticaria study in symptomatic dermographism and cold urticaria, with two-thirds of cold urticaria patients and half of symptomatic dermographism patients achieving complete response at 20 weeks. A Phase 3 study for inducible urticaria will initiate in December 2025.
Enrollment for the Phase 3 CSU studies is on track to complete by mid-2026 , and Phase 2 studies for prurigo nodularis (PN) and atopic dermatitis (AD) are expected to read out in the second half of 2026.
Initial single ascending dose data for the bispecific CDX-622 showed good exposure, no immunogenicity, and significant decreases in circulating tryptase levels without KIT-related adverse events.
The company reported a cash position of $583 million, providing a runway through 2027.

Nov 11, 2025, 3:00 PM

Transcript

Celldex Therapeutics Reports Q3 2025 Financial Results and Provides Corporate Update

CLDX

Earnings

Guidance Update

New Projects/Investments

Celldex Therapeutics reported total revenues of $0.0 million for the third quarter of 2025, compared to $3.2 million for the same period in 2024, and a net loss of $67.0 million, or ($1.01) per share, for Q3 2025.
As of September 30, 2025, the company's cash, cash equivalents, and marketable securities totaled $583.2 million, which is expected to fund planned operations through 2027.
The company plans to initiate a global Phase 3 study for barzolvolimab in cold urticaria and symptomatic dermographism in December 2025, following positive Phase 2 data.
Teri Lawver has joined Celldex as Senior Vice President, Chief Commercial Officer, to support the potential commercialization of barzolvolimab.

Nov 10, 2025, 9:01 PM

8-K

Celldex Announces Positive Initial Phase 1 Results for CDX-622

CLDX

New Projects/Investments

Celldex reported positive initial data from the Phase 1 study of CDX-622, a novel bispecific antibody targeting inflammation and fibrosis.
CDX-622 was well tolerated, exhibited a good pharmacokinetic profile, and led to rapid and sustained reductions in serum tryptase, indicating mast cell inhibition and depletion.
The drug demonstrated a long half-life of approximately 18 days at 9 mg/kg with no measurable immunogenicity.
Celldex has progressed the study to test multiple ascending doses and plans to initiate a Phase 1b study in mild to moderate asthma patients next year.
Data from Part 2 and Part 3 of the Phase 1 study are expected in Q3 2026.