HAMPTON, N.J., Dec. 19, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the Company has initiated a Phase 2 study of barzolvolimab in atopic dermatitis (AD) and that the study is actively enrolling patients. AD is one of the most common chronic inflammatory skin diseases, with a lifetime prevalence of up to 20% of the US population and a substantial impact on quality of life 1 . Mast... Read More

HAMPTON, N.J., Nov. 20, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the first patient has been dosed in the Company’s Phase 1a study of CDX-622 in healthy volunteers. CDX-622 is a bispecific antibody that targets two complementary pathways that drive chronic inflammation, potently neutralizing the alarmin thymic stromal lymphopoietin (TSLP) and depleting mast cells via stem cell... Read More

HAMPTON, N.J., Nov. 11, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc . (NASDAQ:CLDX) announced today that management will participate in fireside chats at two upcoming conferences: Guggenheim Healthcare Innovation Conference on Tuesday, November 12 th at 4:00 p.m. ET 7th Annual Evercore HealthCONx Conference on Tuesday, December 3 rd at 4:15 p.m. ET Live webcasts of the presentations will be available on the " Events &... Read More

First to demonstrate clinical benefit in patients with chronic inducible urticaria (CIndU) in large, randomized, placebo-controlled study Favorable safety and tolerability Plan to advance CIndU into Phase 3 development Company to host webcast call Monday at 8:00 am ET HAMPTON, N.J., Oct. 26, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today positive results from the Company’s Phase 2 clinical... Read More

HAMPTON, N.J., Oct. 25, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that 12 week results from the Company’s Phase 2 clinical trial of barzolvolimab in two of the most common forms of chronic inducible urticaria (CIndU)—cold urticaria (ColdU) and symptomatic dermographism (SD)—will be presented in a late breaking oral presentation at the American College of Allergy, Asthma & Immunology's... Read More

71% of patients (150 mg Q4W) achieved complete response at Week 52 Rapid, profound and durable improvement in UAS7 as early as Week 1 with a deepening of response over 52 weeks Robust improvement across omalizumab-experienced/refractory/naïve disease Well tolerated through 52 weeks Enrollment to Global Phase 3 CSU trials underway Company to host webcast today at 12:00 pm ET/6:00 pm CEST HAMPTON, N.J., Sept. 25, 2024 (GLOBE... Read More

HAMPTON, N.J., Sept. 16, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that an abstract describing 52 week results from the Company’s Phase 2 clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines, including patients with biologic-refractory disease, has been accepted as a late breaking oral presentation at the... Read More

HAMPTON, N.J., Sept. 12, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that management will participate in fireside chats at two upcoming conferences: 2024 Cantor Global Healthcare Conference on Tuesday, September 17 th at 8:35 a.m. ET TD Cowen's Chronic Urticaria Summit on Friday, September 20 th at 10:00 a.m. ET Live webcasts of the presentations will be available on the " Events &... Read More

Phase 3 CSU studies initiated July 2024 Positive topline Phase 2 CIndU 12 week data reported July 2024 supporting Phase 3 advancement 52 week Phase 2 CSU data and full 12 week Phase 2 CIndU data to be reported 2H 2024 Enrollment continues in Phase 2 PN and EOE studies; Phase 2 AD study to start YE 2024 Celldex’s first bispecific for inflammatory diseases, CDX-622, to enter the clinic this year HAMPTON, N.J., Aug. 08, 2024... Read More

Met primary endpoint demonstrating clinically meaningful and statistically significant complete response rate across both dose groups First large, randomized, placebo-controlled study to demonstrate success in CIndU Favorable safety and tolerability consistent with prior studies Plans to advance CIndU into Phase 3 registration development Company to host webcast call today at 4:30 pm ET HAMPTON, N.J., July 29, 2024 (GLOBE... Read More

EMBARQ-CSU1 and EMBARQ-CSU 2 will enroll more than 1800 patients suffering from CSU Studies include both biologic naïve and experienced patients HAMPTON, N.J., July 16, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today the initiation of its global Phase 3 program, consisting of two Phase 3 trials (EMBARQ-CSU1 and EMBARQ-CSU2) designed to establish the efficacy and safety of barzolvolimab in... Read More

HAMPTON, N.J., June 04, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that management will participate in a fireside chat at the Jefferies Healthcare Conference on Thursday, June 6th at 10:00 am ET. A webcast of the presentation will be available on the " Events & Presentations ” page of the " Investors & Media " section of the Celldex website . A replay will be available for 90 days... Read More

Clinically meaningful and statistically significant improvements across multiple angioedema measurements and barzolvolimab dose groups - Sustained activity with rapid onset within 2 weeks - Data further support barzolvolimab clinical benefit to patients with CSU - HAMPTON, N.J., June 02, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced data demonstrating that barzolvolimab profoundly improves... Read More

HAMPTON, N.J., May 15, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the first patient has been dosed in the Company’s Phase 2 subcutaneous study of barzolvolimab in prurigo nodularis (PN). Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity, which is required for the... Read More

Phase 3 CSU studies expected to initiate in summer 2024 Positive Phase 2 CSU 12 week data reported in late breaking oral presentation at AAAAI 2024; 52 week data to be reported in 2H 2024 Enrollment completed in Phase 2 CIndU study; 12 week data expected 2H 2024 - Phase 2 PN study initiated; enrollment progressing in Phase 2 EoE study - Atopic dermatitis selected as next indication; Phase 2 study to initiate by YE 2024 -... Read More

HAMPTON, N.J., April 17, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that patient enrollment has been completed in the Company’s Phase 2 clinical study of barzolvolimab for the treatment of the two most common forms of chronic inducible urticaria (CIndU)—cold urticaria (ColdU) and symptomatic dermographism (SD). CIndU is characterized by the occurrence of hives or wheals that have an... Read More

HAMPTON, N.J., March 08, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that management will participate in a fireside chat at the Leerink Partners Global Biopharma Conference on Monday, March 11, 2024 at 10:00 a.m. ET. A webcast of the presentation will be available on the "Events & Presentations” page of the "Investors & Media” section of the Celldex website. A replay will be available... Read More

HAMPTON, N.J., March 05, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that Anthony S. Marucci, President and Chief Executive Officer will participate in an “Inflammation & Immunology Corporate Panel Discussion” at TD Cowen’s 44th Annual Health Care Conference. The panel will be held on Tuesday, March 5, 2024 from 2:10 to 3:10 PM ET. A live webcast of the panel discussion will be available... Read More

HAMPTON, N.J., March 05, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (“Celldex” or the “Company”) (Nasdaq: CLDX) today announced the closing of its previously announced underwritten public offering of 9,798,000 shares of its common stock, which includes the exercise in full by the underwriters of their option to purchase an additional 1,278,000 shares of common stock at a public offering price of $47.00 per share.... Read More

HAMPTON, N.J., Feb. 29, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (“Celldex” or the “Company”) (Nasdaq: CLDX) today announced the pricing of an upsized underwritten public offering of 8,520,000 shares of its common stock at a public offering price of $47.00 per share. All of the shares to be sold in the offering are to be sold by Celldex. In connection with the offering, Celldex has granted the underwriters a... Read More

HAMPTON, N.J., Feb. 28, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (“Celldex” or the “Company”) (Nasdaq: CLDX) today announced that it is proposing to offer and sell, subject to market conditions, $250.0 million of shares of its common stock in an underwritten public offering. Celldex expects to grant the underwriters a 30-day option to purchase up to an additional $37.5 million of shares of its common stock. All of... Read More

Phase 3 CSU studies expected to initiate in summer 2024 Positive Phase 2 CSU 12 week data reported in late breaking oral presentation at AAAAI 2024; 52 week data to be reported in 2H 2024 Enrollment nearing completion in Phase 2 CIndU study; Data expected 2H 2024 Phase 2 PN study expected to start in early 2024; Positive Phase 1 PN data reported in oral presentation at WCI 2023 HAMPTON, N.J., Feb. 26, 2024 (GLOBE NEWSWIRE)... Read More

Primary and secondary endpoints met with clinically meaningful and statistically significant decreases in urticaria disease activity across multiple dose groups Sustained activity with rapid onset within 2 weeks Similar improvement in omalizumab-experienced/refractory and omalizumab-naïve disease consistent with unique mechanism of action Favorable safety profile 52 week results and Phase 3 CSU trial initiations anticipated... Read More

HAMPTON, N.J., Feb. 06, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that management will participate in a fireside chat at the Guggenheim Healthcare Talks 6th Annual Biotechnology Conference on Wednesday, February 7, 2024 at 9:00 a.m. ET. A webcast of the presentation will be available on the "Events & Presentations" of the "Investors & Media" section of the Celldex website. A replay... Read More

HAMPTON, N.J., Feb. 05, 2024 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that an abstract describing 12 week results from the Company’s Phase 2 clinical trial of barzolvolimab in patients with moderate to severe chronic spontaneous urticaria (CSU) refractory to antihistamines, including patients with biologic-refractory disease, has been accepted as a late breaking oral presentation at the... Read More

HAMPTON, N.J., Nov. 27, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that management will participate in a fireside chat at the 6th Annual Evercore ISI HealthCONx Conference on Tuesday, November 28 th at 5:05 pm ET. A webcast of the presentation will be available on the " Events & Presentations " page of the " Investors & Media " section of the Celldex website. A replay will be available... Read More

HAMPTON, N.J., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (“Celldex” or the “Company”) (Nasdaq: CLDX) today announced the pricing of an underwritten public offering of 7,425,000 shares of its common stock at a public offering price of $27.00 per share. In connection with the offering, Celldex has granted the underwriters a 30-day option to purchase up to an additional 1,113,750 shares of common stock at the... Read More

HAMPTON, N.J., Nov. 07, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (“Celldex” or the “Company”) (Nasdaq: CLDX) today announced that it is proposing to offer and sell, subject to market conditions, shares of its common stock in an underwritten public offering. Celldex expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. All... Read More

Barzolvolimab met primary endpoint with clinically meaningful and statistically significant decreases in urticaria disease activity across multiple dose groups Mean change from baseline to week 12 in UAS7 of -23.87 in 300 mg q8w dose group and -23.02 in 150 mg q4w dose group Barzolvolimab was generally well tolerated with a favorable safety profile Treatment will continue to 52 weeks; results support further development of... Read More

Response observed as early as week 1 and durable for up to 16 weeks Data support important role for mast cells in the pathogenesis of PN and potentially other chronic itch indications Phase 2 PN study to initiate in early 2024 - Conference call to be held on Monday, November 6 th at 8:00 am ET to discuss study results HAMPTON, N.J., Nov. 05, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced... Read More

Phase 2 CSU enrollment complete; topline data by YE 2023 Phase 1b PN data accepted at World Congress on Itch HAMPTON, N.J., Nov. 02, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the third quarter ended September 30, 2023 and provided a corporate update. "During the third quarter, we were pleased to complete enrollment of our Phase 2 chronic spontaneous urticaria study... Read More

HAMPTON, N.J., Sept. 26, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that an abstract describing the Phase 1b study of barzolvolimab in patients with prurigo nodularis (PN) has been accepted as an oral presentation at the 12th World Congress on Itch (WCI), being held in Miami on Nov 5-7, 2023. Presentation details are below: Abstract Title: Barzolvolimab demonstrates safety and... Read More

HAMPTON, N.J., Sept. 25, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that management will participate in a fireside chat at the Cantor Global Healthcare Conference on Tuesday, September 26 th at 1:00 pm ET. A webcast of the presentation will be available on the " Events & Presentations " page of the " Investors & Media " section of the Celldex website. A replay will be available for 90... Read More

Phase 2 CSU enrollment completed; topline data by YE 2023 Phase 1b PN data in Q4 2023 First patient dosed in Phase 2 EoE study HAMPTON, N.J., Aug. 08, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the second quarter ended June 30, 2023 and provided a corporate update. “Last month, we announced that enrollment in our Phase 2 chronic spontaneous urticaria trial was... Read More

HAMPTON, N.J., July 11, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that patient enrollment has been completed in the Company’s Phase 2 clinical study of barzolvolimab for the treatment of chronic spontaneous urticaria (CSU). Barzolvolimab is a humanized monoclonal antibody that specifically binds the receptor tyrosine kinase KIT with high specificity and potently inhibits its activity,... Read More

HAMPTON, N.J., July 06, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced that the first patient has been dosed in the Company’s Phase 2 subcutaneous study of barzolvolimab in eosinophilic esophagitis (EoE). EoE is the most common type of eosinophilic gastrointestinal disease, a chronic inflammatory disease of the esophagus. Several studies have suggested that mast cells may be an important... Read More

Data updates at EAACI 2023 continue to position barzolvolimab as a potential best-in-class addition to a historically limited treatment landscape At week 24, 55% of all patients with CSU in the 1.5 mg/kg, 3.0 mg/kg and 4.5 mg/kg dose groups had complete response (UAS7) and 69% had well-controlled disease (UCT) Patients in the CSU study with angioedema treated at these doses had profound and durable angioedema symptom... Read More

HAMPTON, N.J., June 08, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that data from the Company’s barzolvolimab program will be presented at the European Academy of Allergy and Clinical Immunology (EAACI) Annual Congress 2023 being held June 9-11 in Hamburg, Germany. PRESENTATION DETAILS Late Breaking Oral Presentation Number 000401: Barzolvolimab Demonstrates Clinical Activity in a... Read More

HAMPTON, N.J., June 02, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that management will participate in a fireside chat at the Jefferies Healthcare Conference on Wednesday, June 7 th at 9:00 am ET. A webcast of the presentation will be available on the " Events & Presentations " page of the " Investors & Media " section of the Celldex website. A replay will be available for 90 days... Read More

HAMPTON, N.J., May 31, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc . (NASDAQ:CLDX) today announced that the first patient has been dosed in a Phase 1 study of CDX-585. CDX-585 combines highly active PD-1 blockade with anti-ILT4 blockade to overcome immunosuppressive signals in T cells and myeloid cells. Celldex plans to develop CDX-585 for the treatment of solid tumors either as monotherapy or in combination with... Read More

HAMPTON, N.J., May 15, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today announced preclinical data from CDX-622, the Company’s bispecific antibody with dual targeting of the alarmin TSLP and stem cell factor (SCF), also known as KIT receptor ligand, developed from its bispecific antibody platform. TSLP and SCF have been shown to contribute to the pathophysiology of various inflammatory, fibrotic and... Read More

Phase 2 CSU enrollment completion expected in Q3 2023 - Phase 1b CSU study and Phase 1 cholinergic cohort both accepted for oral presentation at EAACI 2023 - Phase 2 EoE study expected to initiate in June 2023 - HAMPTON, N.J., May 04, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the first quarter ended March 31, 2023 and provided a corporate update. “This quarter, we... Read More

HAMPTON, N.J., March 29, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that management will participate in a fireside chat at the H.C. Wainwright Autoimmune & Inflammatory Disease Virtual Conference on Thursday, March 30 th at 11:30 am ET. A webcast of the presentation will be available on the " Events & Presentations " page of the " Investors & Media " section of the Celldex website. A... Read More

Phase 1b multi-dose CSU data presented at AAAAI on February 26 Phase 2 CSU enrollment completion expected by Q3 2023 HAMPTON, N.J., Feb. 28, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the fourth quarter and year ended December 31, 2022 and provided a corporate update. “Celldex made significant progress over the past year advancing our pipeline. We reported multiple... Read More

Rapid, profound and durable responses across multiple dosing groups with favorable safety profile observed—positioning barzolimab as a potential best-in-class addition to a historically limited treatment landscape At week 12, 56% of all patients in the 1.5 mg/kg, 3.0 mg/kg and 4.5 mg/kg dose groups had complete response and 76% had well-controlled disease (UAS7/UCT) At week 24, 53% of all patients in the 1.5 mg/kg and 3.0... Read More

HAMPTON, N.J., Feb. 16, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that it has appointed Rita Jain, M.D. to the Company’s Board of Directors. “We are pleased to welcome Dr. Jain to the Celldex Board of Directors at this important time in the Company’s trajectory,” said Anthony Marucci, Co-founder, President and Chief Executive Officer of Celldex Therapeutics. “Dr. Jain’s deep background... Read More

HAMPTON, N.J., Feb. 15, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that management will participate in fireside chat at the SVB Securities Global Biopharma Conference today at 9:20 am ET. A webcast of the presentation will be available on the " Events & Presentations " page of the " Investors & Media " section of the Celldex website. A replay will be available for 90 days following the... Read More

HAMPTON, N.J., Feb. 03, 2023 (GLOBE NEWSWIRE) -- Celldex Therapeutics, Inc. (NASDAQ:CLDX) announced today that data from the Company’s Phase 1b multi-dose study of barzolvolimab in chronic spontaneous urticaria will be presented at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting 2023 being held February 24-27 in San Antonio, Texas. Abstracts will be available on the meeting website today, February... Read More

100% complete response rate in cold urticaria after single dose of barzolvolimab at 1.5 mg/kg, including in omalizumab refractory patients Long term follow up of patients with chronic inducible urticaria treated at 3.0 mg/kg confirm that barzolvolimab-induced responses and mast cell suppression are durable and linked Company to host webcast conference call on Tuesday, December 6 at 8:00 a.m. ET HAMPTON, N.J., Dec. 06, 2022... Read More