Celldex Therapeutics (CLDX) Company Report

Celldex presented additional positive data for barzolvolimab from its completed Phase 2 clinical trials in chronic spontaneous urticaria (CSU) and cold urticaria (ColdU) and symptomatic dermographism (SD) at the 2026 AAAAI Annual Meeting.
In the CSU study, barzolvolimab demonstrated sustained off-treatment efficacy, with up to 41% of patients reporting complete response seven months after their last dose, suggesting disease modification.
For patients who received 52 weeks of barzolvolimab therapy in the CSU study, 71% had at least well-controlled disease at the end of treatment, and 88% of these achieved complete response (UAS7=0).
In the ColdU and SD study, barzolvolimab led to marked and rapid improvement in urticaria control and quality of life, with up to 66% of ColdU patients and 49% of SD patients achieving complete response at Week 20.
Celldex has completed enrollment for its global Phase 3 program in CSU with 1,939 patients and initiated a global Phase 3 study in ColdU and SD in December 2025.

18 hours ago

Press Release

Celldex Reports Q4 and Full Year 2025 Financial Results and Provides Corporate Update

CLDX

Earnings

Guidance Update

New Projects/Investments

Celldex reported a net loss of $81.3 million, or ($1.22) per share, for the fourth quarter of 2025, and a net loss of $258.8 million, or ($3.90) per share, for the full year ended December 31, 2025.
Total revenue for Q4 2025 was $0.1 million and $1.5 million for the full year 2025, primarily due to a decrease in services performed under agreements with Rockefeller University.
Cash, cash equivalents, and marketable securities were $518.6 million as of December 31, 2025, which the company believes is sufficient to fund operations through 2027.
Enrollment was completed six months ahead of guidance in the Phase 3 chronic spontaneous urticaria (CSU) studies for barzolvolimab, with topline data anticipated in Q4 2026 and a BLA submission planned for 2027.
The company also completed enrollment in Phase 2 prurigo nodularis and atopic dermatitis studies, with topline data expected in 2026, and initiated a Phase 1 CDX-622 study in asthma.

3 days ago

8-K

Celldex Completes Enrollment for Barzolvolimab Phase 3 Studies

CLDX

New Projects/Investments

Guidance Update

Product Launch

Celldex has completed enrollment for its global Phase 3 program of barzolvolimab in chronic spontaneous urticaria (CSU), encompassing the EMBARQ-CSU1 and EMBARQ-CSU2 trials.
The enrollment of 1,939 patients was finalized six months ahead of guidance.
The company expects to report topline data in Q4 2026.
A Biologics License Application (BLA) submission for barzolvolimab is projected for 2027.

3 days ago

Press Release

Celldex Therapeutics Provides Update on Barzolvolimab Clinical Trials and Financial Runway

CLDX

Guidance Update

New Projects/Investments

Celldex Therapeutics is actively progressing its lead candidate, barzolvolimab, with two Phase 3 studies for Chronic Spontaneous Urticaria (CSU) expected to complete accrual by summer 2026. Additionally, Phase 3 studies for cold urticaria and symptomatic dermographism commenced in December 2025.
The company completed Phase 2 studies for prurigo nodularis (PN) and atopic dermatitis (AD) in December 2025 and January 2026, respectively, with data readouts anticipated in the second half of 2026.
Celldex is also advancing CDX-622, a bispecific anti-TSLP and SCF molecule, with multiple ascending dose (MAD) data from a healthy volunteer study expected around summer 2026, and a proof-of-mechanism study initiated in asthma patients.
The company reported a cash position of $583 million at the end of the third quarter of 2025, providing a projected cash runway through 2027.

Feb 11, 2026, 8:30 PM

Transcript

Celldex Therapeutics Provides 2026 Development Milestones and Financial Outlook

CLDX

Guidance Update

New Projects/Investments

Product Launch

Celldex Therapeutics expects to complete accrual for its two Phase 3 studies of barzolvolimab in Chronic Spontaneous Urticaria (CSU) by summer 2026, with a total of 1,830 patients across 43 countries. The company will provide an update on accrual guidance at the end of February 2026.
Data from Phase 2 studies of barzolvolimab in atopic dermatitis (AD) and prurigo nodularis (PN) are anticipated in the second half of 2026. The company aims to replicate strong Phase 2 CSU results, which showed up to a 70% complete response rate and 41% of patients still responding seven months post-treatment.
The bispecific candidate CDX-622, targeting stem cell factor and TSLP, has shown a 24-day half-life and no safety signals in healthy volunteer studies, with significant mast cell knockdown. Data from the multiple ascending dose (MAD) portion and a subcutaneous formulation are expected around summer 2026.
The company reported a cash position of $583 million at the end of Q3 2025, which is projected to fund operations through 2027. Additional capital will be required for product launch and further development.

Feb 11, 2026, 8:30 PM

Transcript

Celldex Therapeutics Provides Clinical Development Updates and Financial Outlook at Biotech Summit

CLDX

Guidance Update

New Projects/Investments

Celldex Therapeutics initiated Phase 3 studies for cold urticaria and symptomatic dermographism in December 2025 and concluded Phase 2 studies for prurigo nodularis (PN) and atopic dermatitis (AD) in late 2025/early 2026.
The company expects to complete accrual for its two Phase 3 chronic spontaneous urticaria (CSU) studies by summer 2026, with data from the AD and PN studies anticipated in the second half of 2026.
Clinical data for barzolvolimab has shown up to a 70% complete response rate and 41% persistence of effect seven months after the last dose, with a consistent and comfortable safety profile.
The bispecific candidate, CDX-622, demonstrated an over 24-day half-life and significant mast cell knockdown in healthy volunteers, with multiple ascending dose data expected around summer 2026.
Celldex reported a cash position of $583 million at the end of Q3, which is projected to fund operations through 2027.

Feb 11, 2026, 8:30 PM

Transcript

Celldex Initiates Phase 3 Trial for Barzolvolimab in Cold Urticaria and Symptomatic Dermographism

CLDX

New Projects/Investments

Product Launch

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.