Celldex Therapeutics, Inc. (CLDX) Celldex Therapeutics, Inc. is a biopharmaceutical company dedicated to developing antibody-based treatments, specifically monoclonal and bispecific antibodies, for a range of diseases. Their pipeline features therapeutic candidates aimed at both inflammatory conditions and various forms of cancer. Among their key clinical programs: CDX-0159 is a Phase I monoclonal antibody designed to bind to and inhibit the activity of the KIT receptor tyrosine kinase. CDX-1140 is a human agonist monoclonal antibody that targets CD40, a critical immune response activator found on immune cells such as dendritic cells, macrophages, and B cells, as well as on several cancer cell types. CDX-527 is a bispecific antibody that integrates Celldex's proprietary anti-PD-L1 and CD27 human antibodies. Its mechanism involves combining CD27 costimulation with blockade of the PD-L1/PD-1 pathway to prime and activate anti-tumor T-cell responses. The company has established several research collaborations and licensing agreements, including partnerships with the University of Southampton for developing human antibodies targeting CD27, Amgen Inc. for exclusive rights to CDX-301 and CD40 ligand, and Yale University. Incorporated in 1983, Celldex Therapeutics, Inc. is headquartered in Hampton, New Jersey.
Sector: In Vitro & In Vivo Diagnostic Substances
Industry: Biotechnology
Celldex Therapeutics, Inc. NASDAQ:CLDX Healthcare · Biotechnology
Mkt Cap $2.36B
Vol 0
$ Vol 0
RVOL 0
Earnings 0
Press Release ● Major ⚠ 3
Celldex Announces Positive Results from Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 Studies of Barzolvolimab Which Met Primary and All Key Secondary Endpoints
Celldex's pivotal Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 trials of barzolvolimab in chronic spontaneous urticaria met the primary endpoint and all key secondary endpoints at Week 12 in both dose groups, with highly statistically significant reductions in disease activity versus placebo.
Complete response rates (UAS7=0) reached roughly 42-46% at 12 weeks and 45-54% at 24 weeks versus 9-18% on placebo, with benefit also demonstrated in omalizumab-refractory patients and those with severe disease or severe angioedema.
Barzolvolimab was well tolerated through the 24-week placebo-controlled period with a safety profile consistent with Phase 2, across 1,939 randomized patients in the largest program conducted in antihistamine-refractory CSU.
Management characterized the efficacy as best-in-disease and plans to submit a Biologics License Application to the FDA in 2027, positioning Celldex to build a commercial-stage organization around the asset.
• 1mo ago AI analysis › Press Release
Celldex to Present at Upcoming Investor Conference
Celldex management will host a fireside chat at the Cantor Global Healthcare Conference on September 10, 2026.
The presentation will be webcast live and available for replay on the company's investor website for 90 days.
This is a standard investor-relations event with no new financial or strategic disclosures.
• 1mo ago AI analysis › Press Release ● Major ⚠ 2
Celldex Reports Second Quarter Financial Results and Provides Corporate Update
Celldex reported Q2 revenue of $22,000 with a net loss of $73.5 million, or $0.94 per share, widening from the prior year. The company ended the quarter with $717.6 million in cash, bolstered by an April offering, which is sufficient to fund operations through 2028.
On the clinical front, the Phase 3 program for barzolvolimab in chronic spontaneous urticaria completed enrollment early, with topline data expected in September or October 2026. However, the Phase 2 study in prurigo nodularis failed to meet primary or key secondary endpoints and will be discontinued, while Phase 2 atopic dermatitis data is expected in late 2026.
The bispecific candidate CDX-622 showed positive Phase 1 results with rapid reductions in serum tryptase and was well tolerated. Celldex is advancing expansion studies for CDX-622 into allergic rhinitis and food allergy following an ongoing asthma proof of mechanism study.
• 2mo ago AI analysis › Press Release ● Major ⚠ 2
Celldex Reports Results from Phase 2 Study of Barzolvolimab in Prurigo Nodularis
Celldex's Phase 2 study of barzolvolimab in prurigo nodularis (PN) failed to meet its primary endpoint of itch reduction and key secondary endpoints, leading to the discontinuation of the program in this indication.
Despite the efficacy failure, the drug showed a favorable safety profile and profound systemic mast cell depletion, suggesting mast cells may not drive PN symptoms.
The company remains focused on ongoing Phase 3 trials for chronic spontaneous urticaria (CSU), symptomatic dermographism (SD), and cold urticaria (ColdU), with topline data for CSU expected in September or October 2026.
• 3mo ago AI analysis › Press Release
Celldex Announces Planned Transition of Chief Financial Officer
Celldex CFO Sam Martin plans to retire in 2027, but will remain in his role through March 2027 to facilitate a smooth transition.
Martin has served as CFO since 2017 and joined the company in 2009; the board has initiated a search for his successor.
The outgoing CFO noted that the company expects important Phase 3 data readouts for barzolvolimab later this year.
• 3mo ago AI analysis › Press Release
Celldex Presents Long-Term Barzolvolimab Results Demonstrating Sustained Off-Treatment Improvement in Angioedema in Patients with CSU at the European Academy of Allergy and Clinical Immunology Annual Meeting
Celldex presented long-term Phase 2 data for barzolvolimab at the EAACI Annual Meeting, showing that up to 64% of patients with angioedema remained symptom-free seven months after stopping treatment.
The results demonstrate durable off-treatment benefits, supporting the drug's potential to shift CSU treatment from symptom control to disease modification.
Two Phase 3 trials are now complete with 1,939 patients enrolled across 500 sites; topline data are expected in Q4 2026, supporting a planned BLA submission in 2027.
• 4mo ago AI analysis › Press Release
Celldex Presents Positive First-in-Human Results from Phase 1 Study of Novel Bispecific CDX-622 at the European Academy of Allergy and Clinical Immunology Annual Meeting
Celldex presented positive Phase 1 results for CDX-622, a novel bispecific antibody targeting soluble SCF and TSLP, at the EAACI Annual Meeting.
The data showed rapid, dose-dependent, and durable reductions in serum tryptase, confirming mast cell depletion, with no dose-limiting toxicities or serious adverse events.
The company highlighted that neutralizing soluble SCF selectively inhibits KIT signaling in mast cells without impacting other KIT-dependent functions like spermatogenesis or melanogenesis, supporting a favorable safety profile for future inflammatory disease indications.
• 4mo ago AI analysis › Press Release
Celldex Announces Multiple Upcoming Presentations from Leading Mast Cell Targeting Pipeline at the Upcoming 2026 European Academy of Allergy and Clinical Immunology Annual Congress
Celldex will present three abstracts at the EAACI Annual Congress in Istanbul on June 14, 2026, highlighting its mast cell-targeting pipeline.
Two flash talks will cover barzolvolimab, presenting long-term treatment results in chronic spontaneous urticaria and psychometric validation data in cold urticaria.
A late-breaking poster will share first-in-human Phase 1 results for CDX-622, a novel bispecific antibody targeting TSLP and mast cells via stem cell factor starvation.
• 4mo ago AI analysis › Press Release ● Major
Celldex Reports First Quarter Financial Results and Provides Corporate Update
Celldex announced early completion of enrollment in its pivotal Phase 3 chronic spontaneous urticaria (CSU) studies for barzolvolimab, six months ahead of guidance, with topline data expected in Q4 2026.
The company capitalized on this momentum by raising $345 million in gross proceeds from a follow-on public offering closed in April 2026, extending its cash runway into 2028.
Q1 financial results showed revenue of $0.0 million and a net loss of $78.7 million, driven by increased R&D expenses related to the advancing barzolvolimab trials.
• 5mo ago AI analysis › 
