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Celldex Announces Upcoming Late Breaking Oral Presentation of 12 Week Results from Barzolvolimab Phase 2 Study in Chronic Inducible Urticaria at ACAAI 2024

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Celldex Therapeutics (NASDAQ:CLDX) announced upcoming presentation of 12-week results from their Phase 2 clinical trial of barzolvolimab in chronic inducible urticaria (CIndU). The study focused on two common forms: cold urticaria and symptomatic dermographism. The presentation, titled 'Positive Efficacy and Favorable Safety of Barzolvolimab in Chronic Inducible Urticaria: Phase 2 Trial Results,' will be delivered as a late-breaking oral presentation at the American College of Allergy, Asthma & Immunology's Annual Scientific Meeting in Boston on October 26th, 2024.

Celldex Therapeutics (NASDAQ:CLDX) ha annunciato la prossima presentazione dei risultati di 12 settimane del loro studio clinico di Fase 2 su barzolvolimab nella orticaria indotta cronica (CIndU). Lo studio si è concentrato su due forme comuni: l'orticaria da freddo e il dermografismo sintomatico. La presentazione, intitolata 'Efficacia Positiva e Sicurezza Favorable di Barzolvolimab nell'Orticaria Indotta Cronica: Risultati dello Studio di Fase 2,' sarà effettuata come presentazione orale a tarda rottura durante il Collegio Americano di Allergia, Asma e Immunologia - Conferenza Scientifica Annuale a Boston il 26 ottobre 2024.

Celldex Therapeutics (NASDAQ:CLDX) anunció la próxima presentación de los resultados a 12 semanas de su ensayo clínico de Fase 2 de barzolvolimab en urticaria inducible crónica (CIndU). El estudio se centró en dos formas comunes: urticaria por frío y dermografismo sintomático. La presentación, titulada 'Eficacia Positiva y Seguridad Favorable de Barzolvolimab en Urticaria Inducible Crónica: Resultados del Ensayo de Fase 2,' se realizará como una presentación oral a última hora en la Reunión Científica Anual del Colegio Americano de Alergia, Asma e Inmunología en Boston el 26 de octubre de 2024.

셀덱스 치료제 (NASDAQ:CLDX)는 만성 유발 두드러기 (CIndU)에 대한 바르졸볼리맙의 2상 임상 시험 12주 결과 발표를 예정하고 있다고 발표했습니다. 연구는 두 가지 일반적인 형태, 즉 차가운 두드러기와 증상성 피부과 선을 중심으로 진행되었습니다. '만성 유발 두드러기에서 바르졸볼리맙의 긍정적인 효능과 우호적인 안전성: 2상 시험 결과'라는 제목의 발표는 미국 알레르기, 천식 및 면역학회 연례 과학 회의에서 보스턴의 2024년 10월 26일에 구두 발표로 진행될 예정입니다.

Celldex Therapeutics (NASDAQ:CLDX) a annoncé la prochaine présentation des résultats de 12 semaines de son essai clinique de Phase 2 sur le barzolvolimab dans l'urticaire chronique induite (CIndU). L'étude s'est concentrée sur deux formes courantes : l'urticaire froide et le dermographisme symptomatique. La présentation, intitulée 'Efficacité Positive et Sécurité Favorable du Barzolvolimab dans l'Urticaire Chronique Induite : Résultats de l'Essai de Phase 2,' sera présentée lors d'une communication orale à la Réunion Scientifique Annuelle de l'American College of Allergy, Asthma & Immunology à Boston le 26 octobre 2024.

Celldex Therapeutics (NASDAQ:CLDX) gab die bevorstehende Präsentation der 12-Wochen-Ergebnisse ihrer Phase-2-Studie zu Barzolvolimab bei chronischer induzierter Urtikaria (CIndU) bekannt. Die Studie konzentrierte sich auf zwei häufige Formen: Kälteurtikaria und symptomatisches Dermographismus. Die Präsentation mit dem Titel 'Positive Wirksamkeit und günstige Sicherheit von Barzolvolimab bei chronischer induzierter Urtikaria: Ergebnisse der Phase-2-Studie' wird am 26. Oktober 2024 als späte mündliche Präsentation auf dem Jahrestreffen der American College of Allergy, Asthma & Immunology in Boston gehalten.

Positive
  • Phase 2 trial results described as showing 'positive efficacy and favorable safety' in the presentation title
  • Study results selected for late-breaking presentation at major medical conference
Negative
  • None.

Insights

This announcement of upcoming Phase 2 trial results presentation is not considered impactful for immediate investor consideration. While clinical trial results are typically significant market movers, this news merely announces a future presentation of data without revealing the actual results. The presentation's scheduling at ACAAI 2024, while prestigious, falls into the category of routine conference updates.

The focus on barzolvolimab's development in chronic inducible urticaria (CIndU) represents an important pipeline program for Celldex, but without actual data or outcomes being disclosed, this news does not provide actionable information for investors. Market response typically occurs when the actual trial results are presented and their implications for the drug's commercial potential can be assessed.

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 (ACAAI) Annual Scientific Meeting being held in Boston October 24-28, 2024.

Presentation details are as follows:

Abstract Title: Positive Efficacy and Favorable Safety of Barzolvolimab in Chronic Inducible Urticaria: Phase 2 Trial Results
Presenting Author: Jonathan Bernstein, MD, Professor of Clinical Medicine, Department of Internal Medicine, Division of Rheumatology, Allergy and Immunology, University of Cincinnati Medical Center and Partner, Bernstein Allergy Group and Clinical Research Center
Session: LBA003: Distinguished Industry & Late-breaking Oral Abstracts
Date/Time: Saturday, October 26th at 5:43 pm ET

About Celldex Therapeutics, Inc.
Celldex is a clinical stage biotechnology company leading the science at the intersection of mast cell biology and the development of transformative therapeutics for patients. Our pipeline includes antibody-based therapeutics which have the ability to engage the human immune system and/or directly affect critical pathways to improve the lives of patients with severe inflammatory, allergic, autoimmune and other devastating diseases. Visit www.celldex.com.

Forward Looking Statement
This release contains "forward-looking statements" made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as "believes," "expects," "anticipates," "intends," "will," "may," "should," or similar expressions. These forward-looking statements reflect management's current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, our ability to successfully complete research and further development and commercialization of Company drug candidates, including barzolvolimab (also referred to as CDX-0159), in current or future indications; the uncertainties inherent in clinical testing and accruing patients for clinical trials; our limited experience in bringing programs through Phase 3 clinical trials; our ability to manage and successfully complete multiple clinical trials and the research and development efforts for our multiple products at varying stages of development; the availability, cost, delivery and quality of clinical materials produced by our own manufacturing facility or supplied by contract manufacturers, who may be our sole source of supply; the timing, cost and uncertainty of obtaining regulatory approvals; the failure of the market for the Company's programs to continue to develop; our ability to protect the Company's intellectual property; the loss of any executive officers or key personnel or consultants; competition; changes in the regulatory landscape or the imposition of regulations that affect the Company's products; our ability to continue to obtain capital to meet our long-term liquidity needs on acceptable terms, or at all, including the additional capital which will be necessary to complete the clinical trials that we have initiated or plan to initiate; and other factors listed under "Risk Factors" in our annual report on Form 10-K and quarterly reports on Form 10-Q.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.

Company Contact
Sarah Cavanaugh
Senior Vice President, Corporate Affairs & Administration
(508) 864-8337
scavanaugh@celldex.com

Patrick Till
Meru Advisors
(484) 788-8560
ptill@meruadvisors.com


FAQ

What are the Phase 2 trial results for Celldex's (CLDX) barzolvolimab in chronic inducible urticaria?

The complete 12-week results will be presented on October 26th, 2024, at the ACAAI Annual Scientific Meeting. The presentation title indicates positive efficacy and favorable safety outcomes.

What conditions is Celldex (CLDX) targeting with barzolvolimab in their Phase 2 trial?

The Phase 2 trial targets two forms of chronic inducible urticaria (CIndU): cold urticaria (ColdU) and symptomatic dermographism (SD).

When will Celldex (CLDX) present the barzolvolimab Phase 2 trial results?

The results will be presented on Saturday, October 26th, 2024, at 5:43 pm ET during the ACAAI Annual Scientific Meeting in Boston.

Celldex Therapeutics, Inc

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