|
|
|
|
|
|
|
|
|
22.09.26 - 13:01
|
Celldex Announces Positive Results from Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 Studies of Barzolvolimab Which Met Primary and All Key Secondary Endpoints (GlobeNewswire EN)
|
|
|
HAMPTON, N.J., Sept. 22, 2026 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) today reported positive topline results from the Company's Phase 3 EMBARQ-CSU1 and EMBARQ-CSU2 trials evaluating two doses of barzolvolimab in patients with chronic spontaneous urticaria (CSU) whose symptoms are inadequately controlled by H1-antihistamines. The EMBARQ-CSU1 and EMBARQ-CSU2 studies are the largest program conducted in antihistamine refractory CSU, including patients with advanced therapy experienced/refractory CSU. Both Phase 3 trials met the primary endpoint of mean change from baseline in weekly urticaria activity score (UAS7) at Week 12, and all key secondary endpoints, demonstrating clinically meaningful and statistically significant improvements in disease activity. Barzolvolimab was well-tolerated through the 24 week placebo controlled treatment period with a favorable safety profile consistent with prior Phase 2 experience. The EMBARQ-CSU trials are ongoing, with treatment continuing through 52 weeks. The Comp...
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
21.07.26 - 22:03
|
Celldex Reports Results from Phase 2 Study of Barzolvolimab in Prurigo Nodularis (GlobeNewswire EN)
|
|
|
HAMPTON, N.J., July 21, 2026 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) today reported topline results from the Company's Phase 2 study of barzolvolimab delivered subcutaneously in prurigo nodularis (PN), a chronic skin disease that causes hard, intensely itchy lumps/nodules to form on the skin. The primary endpoint of the study, the proportion of patients who achieve a four point or greater improvement in WI-NRS (Worst Itch Numeric Rating Scale) from baseline to Week 12, and key secondary endpoints were not met....
|
|
|
|
|
15.07.26 - 22:03
|
Celldex Announces Planned Transition of Chief Financial Officer (GlobeNewswire EN)
|
|
|
HAMPTON, N.J., July 15, 2026 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) announced today that Sam Martin, Senior Vice President and Chief Financial Officer, has informed the Company of his plans to retire in 2027. Mr. Martin has served as the Company's Chief Financial Officer since 2017 and as a member of the Celldex finance team since April 2009. Celldex has initiated a search for a new Chief Financial Officer, and Mr. Martin will remain as the Company's CFO through March of 2027, to support a smooth transition....
|
|
|
|
|
|
|
14.06.26 - 11:18
|
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 (GlobeNewswire EN)
|
|
|
HAMPTON, N.J., June 14, 2026 (GLOBE NEWSWIRE) -- Celldex (NASDAQ:CLDX) today presented positive results from the Phase 1 healthy participant study of CDX-622, a novel, bispecific antibody that targets soluble SCF and TSLP, at the European Academy of Allergy and Clinical Immunology (EAACI) Annual Meeting in Istanbul, Türkiye. Data demonstrated that CDX-622 induced rapid, durable, dose-dependent reductions in serum tryptase, indicative of mast cell depletion, and was well-tolerated at all dose levels. Building on Celldex's leadership in mast cell science, the data also demonstrated that neutralizing soluble stem cell factor (SCF) enables the potential for meaningful mast cell inhibition and depletion without impacting other KIT-dependent functions. CDX-622 is currently being studied in a Phase 1b proof of mechanism study in mild to moderate asthma to assess the impact of dual neutralization of SCF and TSLP....
|
|
|
|
|
|
|
|