Latest news with #DBVTechnologies
Yahoo
3 days ago
- Business
- Yahoo
DBV Technologies announces filing of 2025 Half-Year Report ― Conditions for accessing or consulting the Report
Châtillon, France, July 29, 2025 DBV Technologies announces filing of 2025 Half-Year Report ― Conditions for accessing or consulting the Report DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a clinical-stage biopharmaceutical company focused on treatment options for food allergies and other immunologic conditions with significant unmet medical need (the 'Company'), today announced the filing, for the semester ended June 30, 2025, of its Half-Year Report with the French market authority, 'Autorité des Marchés Financiers' ('AMF'). The 2025 Half-Year Report can be consulted or downloaded from the Company's website ( in the section Investors/Financial Information, and on the AMF website ( in French only. It is also available free of charge upon request: - by mail : DBV Technologies – 107 avenue de la République 92320 Châtillon, France ; - by email: investors@ About DBV Technologies DBV Technologies is a clinical-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV is currently focused on investigating the use of its proprietary VIASKIN® patch technology to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT), the VIASKIN® patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual's underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin's immune tolerizing properties. DBV is committed to transforming the care of food allergic people. The Company's food allergy programs include ongoing clinical trials of VIASKIN Peanut in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age). DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company's ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Company's ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Market (Ticker: DBVT; CUSIP: 23306J309). For more information, please visit and engage with us on X (formerly Twitter) and LinkedIn. Investor Contact Katie MatthewsDBV Media ContactBrett WhelanDBV Attachment PDF VersionSign in to access your portfolio
Yahoo
22-07-2025
- Business
- Yahoo
DBV Technologies Announces Appointment of James Briggs as Chief Human Resources Officer
DBV Technologies S.A. Châtillon, France, July 22, 2025 DBV Technologies Announces Appointment of James Briggs as Chief Human Resources Officer DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Market: DBVT), a clinical-stage biopharmaceutical company, today announced the appointment of James Briggs as its Chief Human Resources Officer, succeeding Caroline Daniere. An experienced human capital executive, James will lead key initiatives as DBV transitions from a development-stage biotechnology company to a potential commercial organization. Mr. Briggs will report directly to Daniel Tassé, Chief Executive Officer, and serve as a member of the Executive Committee. 'I want to thank Caroline for her extraordinary leadership and express sincere gratitude for the teams she has built and the culture she has cultivated,' said Daniel Tassé Chief Executive Officer, DBV Technologies. "Like Caroline, James has a rare eye for talent and ability to find the right people-driven solutions. His proven track record in driving enterprise value through talent strategy and organizational transformation will be invaluable as we scale our operations and prepare for potential commercialization." Most recently, Mr. Briggs served as Partner at East Bay Human Capital, a human resources consulting firm specializing in human capital strategy, change management, and organizational design. Previously, he held several executive roles, including Chief Executive Officer at MNG Health, where he led the successful turnaround and sale of the healthcare technology company. He also served as Chief Human Resources Officer at multiple organizations, including Ciox Health and Ikaria Inc. "This is a pivotal moment for DBV as we prepare to transition from our clinical development focus to building the infrastructure and capabilities needed for commercial success," said James Briggs. "I'm excited to join this talented leadership team and help build upon the organizational foundation that will support our mission to bring life-changing treatments to patients who need them most." Mr. Briggs holds a Master's degree in Human Relations and a Bachelor's degree in Communications from the University of Illinois at Urbana-Champaign. He is a certified Senior Professional in Human Resources (SPHR) and a Six Sigma Green Belt. About DBV Technologies DBV Technologies is a clinical-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV is currently focused on investigating the use of its proprietary VIASKIN® patch technology to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT), the VIASKIN® patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual's underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin's immune tolerizing properties. DBV is committed to transforming the care of food allergic people. The Company's food allergy programs include ongoing clinical trials of VIASKIN Peanut in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age).
Malaysian Reserve
16-07-2025
- Health
- Malaysian Reserve
Peanut Allergy Market Set to Grow at a 16% CAGR During the Study Period (2020-2034) Owing to Current Usage of Epinephrine, Anticipated Usage of XOLAIR in Adults, PALFORZIA in Toddlers and Expected Ent
The evolving peanut allergy treatment market landscape features clinical trials led by DBV Technologies (Viaskin [DBV712] Peanut Patch), Novartis (Remibrutinib), Aravax (PVX108), ALK-Abello (Sublingual Immunotherapy-Tablet), InnoUp Farma (INP20), Allergy Therapeutics (VLP Peanut), Intrommune Therapeutics (INT301), Regeneron Pharmaceuticals (Linvoseltamab + Dupilumab), and others. LAS VEGAS, July 16, 2025 /PRNewswire/ — DelveInsight's Peanut Allergy Market Insights report includes a comprehensive understanding of current treatment practices, peanut allergy emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Peanut Allergy Market Report According to DelveInsight's analysis, the market size for peanut allergy was found to be USD 400 million in the 7MM in 2024, and is expected to witness a drastic growth owing to increased usage of approved therapies, expected entry of novel emerging therapies, and a slight increase in diagnosis over time. In 2024, the US reported approximately ˜5,129,500 prevalent cases of peanut allergy, yet only about 50% of affected individuals received treatment, highlighting a significant gap in patient care and therapy adoption. PALFORZIA has seen limited uptake due to modest clinical benefits over standard peanut avoidance, with minimal impact on reducing allergic reactions Following PALFORZIA's approval in the US, Roche and Novartis' XOLAIR was approved in early 2024, adding a new option to the food allergy treatment landscape, including peanut allergy. Although XOLAIR could be a lucrative option for adult patients with minimal needle phobia, XOLAIR's high annual cost may pose a barrier to affordability and patient access, potentially hindering its broader adoption. By 2034, among all the therapies, the highest revenue is expected to be generated by VIASKIN in the 7MM. Around 70% of treated patients choose desensitization, reflecting strong demand, creatinga clear opportunity for safer, easier alternatives like Viaskin to improve adoption and long-term protection Based on DelveInsight's assessment in 2024, the 7MM had 9.8 million diagnosed prevalent cases of peanut allergy. Mild-to-moderate peanut allergy contributed majorly t in 2024 within the 7MM. Our trend estimates suggest a consistent rise in these cases during the study period (2020–2034). Leading peanut allergy companies developing emerging therapies, such as DBV Technologies, Novartis, Aravax, ALK-Abello, InnoUp Farma, Intrommune Therapeutics, and others, are developing novel peanut allergy drugs that can be available in the peanut allergy market in the coming years. The promising peanut allergy therapies in the pipeline include Viaskin (DBV712) peanut patch, Remibrutinib (LOU064), PVX108 (AVX-201), Sublingual Immunotherapy (SLIT)-Tablet, INP20, INT301, and others. Discover which therapies are expected to grab the peanut allergy therapeutics market share @ Peanut Allergy Market Report Peanut Allergy Market Dynamics The peanut allergy market dynamics are expected to change in the coming years. PALFORZIA, administered orally, offers a convenient and accessible treatment option compared to traditional SC, intradermal, and epicutaneous therapies, potentially enhancing patient adherence and reducing the burden on healthcare systems; desensitization has improved peanut allergy treatment by increasing the reaction threshold, helping prevent accidental anaphylaxis and offering meaningful protection for patients and families, while the adult peanut allergy market remains an untapped opportunity, with XOLAIR as the sole approved treatment and only remibrutinib under evaluation, highlighting significant potential for growth, especially as increasing investment and partnerships in the allergy treatment space accelerate the development of novel therapies. Furthermore, potential therapies are being investigated for the treatment of peanut allergy, and it is safe to predict that the treatment space will significantly impact the peanut allergy market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the peanut allergy market in the 7MM. However, several factors may impede the growth of the peanut allergy market. Notable weakness in the peanut allergy landscape is the slow uptake of PALFORZIA, underdiagnosis of mild patients, lack of approved treatment options for adult patients(except XOLAIR), with remibrutinib being the only drug currently under evaluation for the 18–55 age group. This is compounded by the limited number of active drugs in the pipeline, highlighting a gap in therapeutic innovation that restricts treatment options and hinders progress in addressing diverse patient needs. Additionally, the high annual cost of XOLAIR, ranging from USD 30,000 to USD 60,000, poses a significant threat by limiting affordability and access, thereby challenging its widespread adoption. Furthermore, inconsistent or unclear food labeling practices increase the risk of accidental exposure, complicating condition management and posing ongoing risks for individuals with peanut allergies. Moreover, peanut allergy treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the peanut allergy market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the peanut allergy market growth. Peanut Allergy Treatment Market Managing peanut allergies requires a comprehensive approach, with strict avoidance of the allergen remaining the key method for preventing severe, potentially fatal anaphylactic reactions. However, recent clinical guidelines mark a significant change in prevention strategies by recommending the early introduction of peanut-containing foods between 4 to 6 months of age, even for infants at high risk. This proactive approach has been shown to greatly reduce the chances of developing a peanut allergy, replacing the older practice of strict avoidance. While medications such as antihistamines, corticosteroids, and bronchodilators can be used during allergic reactions, it's important to note that they do not treat anaphylaxis directly. These are supportive treatments used alongside other interventions in managing anaphylactic episodes. Although allergen avoidance remains the foundation of care, innovative preventive measures are under development. One such method, oral immunotherapy, involves gradually increasing exposure to small amounts of peanut, and clinical trials have shown encouraging results. Another promising desensitization technique is epicutaneous immunotherapy, where peanut protein is applied to the skin over time to help build tolerance. This form of therapy has improved peanut allergy management by increasing the reaction threshold, lowering the risk of accidental exposure, and providing patients with added protection and confidence. Currently, PALFORZIA and XOLAIR are the only approved treatments for peanut allergy. PALFORZIA is authorized for children aged 1–3 and 4–17 years, while XOLAIR is approved for individuals aged 1 year and older. These peanut allergy therapies offer valuable options for both patients and healthcare professionals in managing peanut allergies. To know more about peanut allergy treatment options, visit @ Peanut Allergy Medication Peanut Allergy Pipeline Therapies and Key Companies A robust pipeline of emerging therapies for peanut allergy is progressing, driven by innovative treatments with diverse mechanisms of action, such as Remibrutinib (Novartis), INP20 (InnoUp Farma), SLIT tablet (ALK-Abello), INT301 (Intrommune Therapeutics), and the combination of Linvoseltamab and Dupilumab. Among these, the Viaskin Peanut Patch (DBV Technologies) stands out as a promising noninvasive option, offering ease of use and a strong safety profile, which may make it especially suitable for young children aged 1 to 7. Viaskin Peanut is an epicutaneous immunotherapy (EPIT) that delivers trace amounts of peanut protein via a skin patch to promote desensitization in allergic individuals. It has received both Fast Track and Breakthrough Therapy Designations from the US FDA. The therapy is currently being assessed in a Phase III clinical trial involving peanut-allergic children aged 4 to 7. DBV Technologies expects to share top-line data from the VITESSE trial (NCT05741476) in Q4 2025. In March 2025, DBV Technologies and the FDA aligned on key regulatory steps following written responses to a Type D IND meeting request. The FDA agreed that safety exposure data from the VITESSE Phase III trial in children aged 4–7 would be adequate to support a Biologics License Application (BLA) for this age group, potentially advancing the BLA submission to the first half of 2026. A separate BLA for children aged 1–3 is planned for the second half of 2026, contingent on the successful outcome of the COMFORT Toddlers Study. PVX108 is a next-generation immunotherapy that utilizes engineered peptides to specifically engage T cells and retrain the immune system, aiming to reverse allergic responses. It is currently in a Phase II clinical trial for children and adolescents with peanut allergies. In November 2024, Aravax established a UK subsidiary at Oxford Science Park, marking a strategic step in its global expansion in food allergy treatment. Additionally, in October 2024, the company completed patient enrollment for its Phase II study (AVX-201) evaluating PVX108. Remibrutinib is an oral, highly selective, covalent Bruton's Tyrosine Kinase (BTK) inhibitor being developed for a range of autoimmune and inflammatory conditions, including chronic spontaneous urticaria, myasthenia gravis, multiple sclerosis, food allergy, and hidradenitis suppurativa. It is currently in a Phase II clinical trial for adults with peanut allergy. These new peanut allergy therapies, which act on different molecular targets and pathways, represent encouraging alternatives to existing treatments. Their development underscores a growing emphasis on more precise and targeted strategies for managing the complexities of peanut allergy Additionally, the anticipated launch of these emerging therapies are poised to transform the peanut allergy market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the peanut allergy market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. Discover more about peanut allergy drugs in development @ Peanut Allergy Clinical Trials Recent Developments in the Peanut Allergy Market In March 2025, DBV Technologies reached an understanding with the US FDA based on written replies to its Type D IND meeting request. The FDA concurred with DBV's proposal that safety exposure data from the VITESSE Phase III study of the Viaskin Peanut Patch in children aged 4–7 years would be sufficient to support BLA filing for this age group, thereby accelerating the anticipated timeline for BLA submission to the first half of 2026. In March 2025, the US FDA approved OMLYCLO (omalizumab-igec) as the first interchangeable biosimilar for reference XOLAIR and the first respiratory biosimilar for the treatment of moderate-to-severe persistent asthma, Chronic Rhinosinusitis with Nasal Polyps (CRSwNP), IgE-mediated food allergy, and Chronic Spontaneous Urticaria (CSU). In March 2025, DBV Technologies announced a financing of up to USD 306.9 million (EUR 284.5 million), comprising gross proceeds of USD 125.5 million (EUR 116.3 million) to be received upon closing and up to an additional USD 181.4 million (EUR 168.2 million) in gross proceeds contingent upon the full exercise of warrants, subject to the satisfaction of specified conditions. In February 2025, Stallergenes Greer launched PALFORZIA in the US to treat toddler patients, ages 1–3 years, with a confirmed diagnosis of peanut allergy. The FDA approved the expanded indication for toddler patients (ages 1–3 years) in July 2024 based on the data from the Phase III POSEIDON (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization) study that was published in the New England Journal of Medicine Evidence in 2023. In January 2025, the European Commission approved the extension of the indication of PALFORZIA for the treatment of toddlers (ages 1–3) with a confirmed diagnosis of peanut allergy. The marketing authorization covered all 27 European member states and the three European Economic Area states (Iceland, Liechtenstein, and Norway). In December 2024, ALK announced positive interim results from the Phase I/II clinical trial (ALLIANCE) for its investigational SLIT tablet for the treatment of peanut allergy. Peanut Allergy Overview Peanut allergy is one of the most prevalent food allergies in children and has notably increased over recent decades. It results from an abnormal immune response involving IgE antibodies directed against peanut proteins, which can cause severe and potentially life-threatening anaphylactic reactions. Beyond the immediate health dangers, this allergy significantly affects the quality of life for both patients and their families. Compared to other IgE-mediated food allergies, peanut allergy is associated with a higher incidence of anaphylaxis-related fatalities in emergencies. In individuals with this allergy, the initial exposure to peanut antigens activates Th2 cells that release cytokines, encouraging the production of IgE antibodies. These antibodies attach to Fce receptors on mast cells and basophils, sensitizing them. Upon subsequent exposure, the allergen crosslinks the IgE on these primed cells, leading to degranulation and the release of inflammatory mediators such as histamine, leukotrienes, and cytokines. This response triggers vasodilation, increased vascular permeability, and inflammation, manifesting in allergic symptoms. In addition to these biochemical processes, mechanical factors in the allergic microenvironment also influence immune activity. When diagnosing peanut and other food allergies, a detailed clinical history is essential to appropriately interpret test results. The most accurate diagnostic method is the double-blind, placebo-controlled food challenge (DBPCFC). However, skin prick testing (SPT) and measurement of specific IgE levels are commonly used first-line tools due to their speed and affordability. Peanut Allergy Epidemiology Segmentation The peanut allergy epidemiology section provides insights into the historical and current peanut allergy patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The peanut allergy market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of Peanut Allergy Gender-specific Cases of Peanut Allergy Age-specific Cases of Peanut Allergy Severity-specific Cases of Peanut Allergy Peanut Allergy Market Report Metrics Details Study Period 2020–2034 Coverage 7MM [The United States, the EU4 (Germany, France, Italy, and Spain) and The United Kingdom, and Japan]. Peanut Allergy Market CAGR 16 % Peanut Allergy Market Size in 2024 USD 400 Million Key Peanut Allergy Companies DBV Technologies, Novartis, Aravax, ALK-Abello, InnoUp Farma, Intrommune Therapeutics, Stallergenes Greer, Roche, and others Key Peanut Allergy Therapies Viaskin (DBV712) peanut patch, Remibrutinib (LOU064), PVX108 (AVX-201), Sublingual Immunotherapy (SLIT)-Tablet, INP20, INT301, PALFORZIA, XOLAIR, and others Scope of the Peanut Allergy Market Report Therapeutic Assessment: Peanut Allergy current marketed and emerging therapies Peanut Allergy Market Dynamics: Key Market Forecast Assumptions of Emerging Peanut Allergy Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Peanut Allergy Market Access and Reimbursement Download the report to understand which factors are driving peanut allergy market trends @ Peanut Allergy Treatment Market Table of Contents 1 Key Insights 2 Report Introduction 3 Executive Summary 4 Key Events 5 Epidemiology and Market Forecast Methodology 6 Peanut Allergy Market Overview at a Glance 6.1 Market Share (%) Distribution by Therapies in 2024 in the 7MM 6.2 Market Share (%) Distribution by Therapies in 2034 in the 7MM 7 Disease Background and Overview 7.1 Introduction 7.2 Symptoms 7.3 Risk Factors 7.4 Pathophysiology of Peanut Allergy 7.5 Diagnosis 7.6 Treatment 8 Epidemiology and Patient Population 8.1 Key Findings 8.2 Assumptions and Rationale: 7MM 8.3 Total Diagnosed Prevalent Cases of Peanut Allergy in the 7MM 8.4 The United States 8.5 EU4 and the UK 8.6 Japan 9 Patient Journey 10 Marketed Drugs 10.1 Key Competitors 10.2 PALFORZIA (peanut allergen powder-dnfp): Stallergenes Greer 10.3 XOLAIR (omalizumab): Roche and Novartis 11 Emerging Therapies 11.1 Key Cross Competition 11.2 Viaskin (DBV712) peanut patch: DBV Technologies 11.3 Remibrutinib (LOU064): Novartis 11.4 PVX108 (AVX-201): Aravax 11.5 Sublingual Immunotherapy (SLIT)-Tablet: ALK-Abello 12 Peanut Allergy: Seven Major Market Analysis 12.2 Market Outlook 12.3 Conjoint Analysis 12.4 Key Market Forecast Assumptions 12.5 DBV Technology: In-depth Analysis 12.6 Total Market Size of Peanut Allergy by Country in the 7MM 12.7 United States Market Size 12.8 EU4 and the UK Market Size 12.9 Japan Market Size 13 Unmet Needs 14 SWOT Analysis 15 KOL Views 16 Market Access and Reimbursement 16.1 United States 16.2 EU4 and the UK 16.3 Japan 16.4 Market Access and Reimbursement of Peanut Allergy 17 Bibliography 18 Report Methodology Related Reports Food Allergy Market Food Allergy Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key food allergy companies including Stallergenes Greer, Roche, Novartis, ARS Pharmaceuticals, ALK-Abelló, Alfresa Pharma, DBV Technologies, Aquestive Therapeutics, Bryn Pharma, Aravax, RAPT Therapeutics, Allergy Therapeutics, Regeneron Pharmaceuticals, among others. Peanut Allergy Pipeline Peanut Allergy Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key peanut allergy companies, including Allergy Therapeutics, DBV Technologies, Novartis, Aravax, ALK-Abello, Intrommune Therapeutics, LAPIX Therapeutics, among others. Food Allergy Pipeline Food Allergy Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key food allergy companies, including DBV Technologies, Aravax, Xencor, Novartis AG, Vedanta Biosciences, Alladapt Immunotherapeutics, Intrommune Therapeutics, IgGenix, Lapix Therapeutics, Neovacs, Inimmune, among others. Lactose Intolerance Market Lactose Intolerance Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key lactose intolerance companies including CRitter Pharmaceuticals Inc., a2 Milk Company Ltd, VenterPharma, Eurofarma Laboratorios S.A, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact UsShruti Thakurinfo@ + Logo: View original content:
Yahoo
16-07-2025
- Health
- Yahoo
Peanut Allergy Market Set to Grow at a 16% CAGR During the Study Period (2020-2034) Owing to Current Usage of Epinephrine, Anticipated Usage of XOLAIR in Adults, PALFORZIA in Toddlers and Expected Entry of Viaskin Peanut Patches
The evolving peanut allergy treatment market landscape features clinical trials led by DBV Technologies (Viaskin [DBV712] Peanut Patch), Novartis (Remibrutinib), Aravax (PVX108), ALK-Abello (Sublingual Immunotherapy-Tablet), InnoUp Farma (INP20), Allergy Therapeutics (VLP Peanut), Intrommune Therapeutics (INT301), Regeneron Pharmaceuticals (Linvoseltamab + Dupilumab), and others. LAS VEGAS, July 16, 2025 /PRNewswire/ -- DelveInsight's Peanut Allergy Market Insights report includes a comprehensive understanding of current treatment practices, peanut allergy emerging drugs, market share of individual therapies, and current and forecasted market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan]. Key Takeaways from the Peanut Allergy Market Report According to DelveInsight's analysis, the market size for peanut allergy was found to be USD 400 million in the 7MM in 2024, and is expected to witness a drastic growth owing to increased usage of approved therapies, expected entry of novel emerging therapies, and a slight increase in diagnosis over time. In 2024, the US reported approximately ˜5,129,500 prevalent cases of peanut allergy, yet only about 50% of affected individuals received treatment, highlighting a significant gap in patient care and therapy adoption. PALFORZIA has seen limited uptake due to modest clinical benefits over standard peanut avoidance, with minimal impact on reducing allergic reactions Following PALFORZIA's approval in the US, Roche and Novartis' XOLAIR was approved in early 2024, adding a new option to the food allergy treatment landscape, including peanut allergy. Although XOLAIR could be a lucrative option for adult patients with minimal needle phobia, XOLAIR's high annual cost may pose a barrier to affordability and patient access, potentially hindering its broader adoption. By 2034, among all the therapies, the highest revenue is expected to be generated by VIASKIN in the 7MM. Around 70% of treated patients choose desensitization, reflecting strong demand, creatinga clear opportunity for safer, easier alternatives like Viaskin to improve adoption and long-term protection Based on DelveInsight's assessment in 2024, the 7MM had 9.8 million diagnosed prevalent cases of peanut allergy. Mild-to-moderate peanut allergy contributed majorly t in 2024 within the 7MM. Our trend estimates suggest a consistent rise in these cases during the study period (2020–2034). Leading peanut allergy companies developing emerging therapies, such as DBV Technologies, Novartis, Aravax, ALK-Abello, InnoUp Farma, Intrommune Therapeutics, and others, are developing novel peanut allergy drugs that can be available in the peanut allergy market in the coming years. The promising peanut allergy therapies in the pipeline include Viaskin (DBV712) peanut patch, Remibrutinib (LOU064), PVX108 (AVX-201), Sublingual Immunotherapy (SLIT)-Tablet, INP20, INT301, and others. Discover which therapies are expected to grab the peanut allergy therapeutics market share @ Peanut Allergy Market Report Peanut Allergy Market Dynamics The peanut allergy market dynamics are expected to change in the coming years. PALFORZIA, administered orally, offers a convenient and accessible treatment option compared to traditional SC, intradermal, and epicutaneous therapies, potentially enhancing patient adherence and reducing the burden on healthcare systems; desensitization has improved peanut allergy treatment by increasing the reaction threshold, helping prevent accidental anaphylaxis and offering meaningful protection for patients and families, while the adult peanut allergy market remains an untapped opportunity, with XOLAIR as the sole approved treatment and only remibrutinib under evaluation, highlighting significant potential for growth, especially as increasing investment and partnerships in the allergy treatment space accelerate the development of novel therapies. Furthermore, potential therapies are being investigated for the treatment of peanut allergy, and it is safe to predict that the treatment space will significantly impact the peanut allergy market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the peanut allergy market in the 7MM. However, several factors may impede the growth of the peanut allergy market. Notable weakness in the peanut allergy landscape is the slow uptake of PALFORZIA, underdiagnosis of mild patients, lack of approved treatment options for adult patients(except XOLAIR), with remibrutinib being the only drug currently under evaluation for the 18–55 age group. This is compounded by the limited number of active drugs in the pipeline, highlighting a gap in therapeutic innovation that restricts treatment options and hinders progress in addressing diverse patient needs. Additionally, the high annual cost of XOLAIR, ranging from USD 30,000 to USD 60,000, poses a significant threat by limiting affordability and access, thereby challenging its widespread adoption. Furthermore, inconsistent or unclear food labeling practices increase the risk of accidental exposure, complicating condition management and posing ongoing risks for individuals with peanut allergies. Moreover, peanut allergy treatment poses a significant economic burden and disrupts patients' overall well-being and QOL. Furthermore, the peanut allergy market growth may be offset by failures and discontinuation of emerging therapies, unaffordable pricing, market access and reimbursement issues, and a shortage of healthcare specialists. In addition, the undiagnosed, unreported cases and the unawareness about the disease may also impact the peanut allergy market growth. Peanut Allergy Treatment Market Managing peanut allergies requires a comprehensive approach, with strict avoidance of the allergen remaining the key method for preventing severe, potentially fatal anaphylactic reactions. However, recent clinical guidelines mark a significant change in prevention strategies by recommending the early introduction of peanut-containing foods between 4 to 6 months of age, even for infants at high risk. This proactive approach has been shown to greatly reduce the chances of developing a peanut allergy, replacing the older practice of strict avoidance. While medications such as antihistamines, corticosteroids, and bronchodilators can be used during allergic reactions, it's important to note that they do not treat anaphylaxis directly. These are supportive treatments used alongside other interventions in managing anaphylactic episodes. Although allergen avoidance remains the foundation of care, innovative preventive measures are under development. One such method, oral immunotherapy, involves gradually increasing exposure to small amounts of peanut, and clinical trials have shown encouraging results. Another promising desensitization technique is epicutaneous immunotherapy, where peanut protein is applied to the skin over time to help build tolerance. This form of therapy has improved peanut allergy management by increasing the reaction threshold, lowering the risk of accidental exposure, and providing patients with added protection and confidence. Currently, PALFORZIA and XOLAIR are the only approved treatments for peanut allergy. PALFORZIA is authorized for children aged 1–3 and 4–17 years, while XOLAIR is approved for individuals aged 1 year and older. These peanut allergy therapies offer valuable options for both patients and healthcare professionals in managing peanut allergies. To know more about peanut allergy treatment options, visit @ Peanut Allergy Medication Peanut Allergy Pipeline Therapies and Key Companies A robust pipeline of emerging therapies for peanut allergy is progressing, driven by innovative treatments with diverse mechanisms of action, such as Remibrutinib (Novartis), INP20 (InnoUp Farma), SLIT tablet (ALK-Abello), INT301 (Intrommune Therapeutics), and the combination of Linvoseltamab and Dupilumab. Among these, the Viaskin Peanut Patch (DBV Technologies) stands out as a promising noninvasive option, offering ease of use and a strong safety profile, which may make it especially suitable for young children aged 1 to 7. Viaskin Peanut is an epicutaneous immunotherapy (EPIT) that delivers trace amounts of peanut protein via a skin patch to promote desensitization in allergic individuals. It has received both Fast Track and Breakthrough Therapy Designations from the US FDA. The therapy is currently being assessed in a Phase III clinical trial involving peanut-allergic children aged 4 to 7. DBV Technologies expects to share top-line data from the VITESSE trial (NCT05741476) in Q4 2025. In March 2025, DBV Technologies and the FDA aligned on key regulatory steps following written responses to a Type D IND meeting request. The FDA agreed that safety exposure data from the VITESSE Phase III trial in children aged 4–7 would be adequate to support a Biologics License Application (BLA) for this age group, potentially advancing the BLA submission to the first half of 2026. A separate BLA for children aged 1–3 is planned for the second half of 2026, contingent on the successful outcome of the COMFORT Toddlers Study. PVX108 is a next-generation immunotherapy that utilizes engineered peptides to specifically engage T cells and retrain the immune system, aiming to reverse allergic responses. It is currently in a Phase II clinical trial for children and adolescents with peanut allergies. In November 2024, Aravax established a UK subsidiary at Oxford Science Park, marking a strategic step in its global expansion in food allergy treatment. Additionally, in October 2024, the company completed patient enrollment for its Phase II study (AVX-201) evaluating PVX108. Remibrutinib is an oral, highly selective, covalent Bruton's Tyrosine Kinase (BTK) inhibitor being developed for a range of autoimmune and inflammatory conditions, including chronic spontaneous urticaria, myasthenia gravis, multiple sclerosis, food allergy, and hidradenitis suppurativa. It is currently in a Phase II clinical trial for adults with peanut allergy. These new peanut allergy therapies, which act on different molecular targets and pathways, represent encouraging alternatives to existing treatments. Their development underscores a growing emphasis on more precise and targeted strategies for managing the complexities of peanut allergy Additionally, the anticipated launch of these emerging therapies are poised to transform the peanut allergy market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the peanut allergy market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. Discover more about peanut allergy drugs in development @ Peanut Allergy Clinical Trials Recent Developments in the Peanut Allergy Market In March 2025, DBV Technologies reached an understanding with the US FDA based on written replies to its Type D IND meeting request. The FDA concurred with DBV's proposal that safety exposure data from the VITESSE Phase III study of the Viaskin Peanut Patch in children aged 4–7 years would be sufficient to support BLA filing for this age group, thereby accelerating the anticipated timeline for BLA submission to the first half of 2026. In March 2025, the US FDA approved OMLYCLO (omalizumab-igec) as the first interchangeable biosimilar for reference XOLAIR and the first respiratory biosimilar for the treatment of moderate-to-severe persistent asthma, Chronic Rhinosinusitis with Nasal Polyps (CRSwNP), IgE-mediated food allergy, and Chronic Spontaneous Urticaria (CSU). In March 2025, DBV Technologies announced a financing of up to USD 306.9 million (EUR 284.5 million), comprising gross proceeds of USD 125.5 million (EUR 116.3 million) to be received upon closing and up to an additional USD 181.4 million (EUR 168.2 million) in gross proceeds contingent upon the full exercise of warrants, subject to the satisfaction of specified conditions. In February 2025, Stallergenes Greer launched PALFORZIA in the US to treat toddler patients, ages 1–3 years, with a confirmed diagnosis of peanut allergy. The FDA approved the expanded indication for toddler patients (ages 1–3 years) in July 2024 based on the data from the Phase III POSEIDON (Peanut Oral Immunotherapy Study of Early Intervention for Desensitization) study that was published in the New England Journal of Medicine Evidence in 2023. In January 2025, the European Commission approved the extension of the indication of PALFORZIA for the treatment of toddlers (ages 1–3) with a confirmed diagnosis of peanut allergy. The marketing authorization covered all 27 European member states and the three European Economic Area states (Iceland, Liechtenstein, and Norway). In December 2024, ALK announced positive interim results from the Phase I/II clinical trial (ALLIANCE) for its investigational SLIT tablet for the treatment of peanut allergy. Peanut Allergy Overview Peanut allergy is one of the most prevalent food allergies in children and has notably increased over recent decades. It results from an abnormal immune response involving IgE antibodies directed against peanut proteins, which can cause severe and potentially life-threatening anaphylactic reactions. Beyond the immediate health dangers, this allergy significantly affects the quality of life for both patients and their families. Compared to other IgE-mediated food allergies, peanut allergy is associated with a higher incidence of anaphylaxis-related fatalities in emergencies. In individuals with this allergy, the initial exposure to peanut antigens activates Th2 cells that release cytokines, encouraging the production of IgE antibodies. These antibodies attach to Fce receptors on mast cells and basophils, sensitizing them. Upon subsequent exposure, the allergen crosslinks the IgE on these primed cells, leading to degranulation and the release of inflammatory mediators such as histamine, leukotrienes, and cytokines. This response triggers vasodilation, increased vascular permeability, and inflammation, manifesting in allergic symptoms. In addition to these biochemical processes, mechanical factors in the allergic microenvironment also influence immune activity. When diagnosing peanut and other food allergies, a detailed clinical history is essential to appropriately interpret test results. The most accurate diagnostic method is the double-blind, placebo-controlled food challenge (DBPCFC). However, skin prick testing (SPT) and measurement of specific IgE levels are commonly used first-line tools due to their speed and affordability. Peanut Allergy Epidemiology Segmentation The peanut allergy epidemiology section provides insights into the historical and current peanut allergy patient pool and forecasted trends for the 7MM. It helps recognize the causes of current and forecasted patient trends by exploring numerous studies and views of key opinion leaders. The peanut allergy market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Diagnosed Prevalent Cases of Peanut Allergy Gender-specific Cases of Peanut Allergy Age-specific Cases of Peanut Allergy Severity-specific Cases of Peanut Allergy Peanut Allergy Market Report Metrics Details Study Period 2020–2034 Coverage 7MM [The United States, the EU4 (Germany, France, Italy, and Spain) and The United Kingdom, and Japan]. Peanut Allergy Market CAGR 16 % Peanut Allergy Market Size in 2024 USD 400 Million Key Peanut Allergy Companies DBV Technologies, Novartis, Aravax, ALK-Abello, InnoUp Farma, Intrommune Therapeutics, Stallergenes Greer, Roche, and others Key Peanut Allergy Therapies Viaskin (DBV712) peanut patch, Remibrutinib (LOU064), PVX108 (AVX-201), Sublingual Immunotherapy (SLIT)-Tablet, INP20, INT301, PALFORZIA, XOLAIR, and others Scope of the Peanut Allergy Market Report Therapeutic Assessment: Peanut Allergy current marketed and emerging therapies Peanut Allergy Market Dynamics: Key Market Forecast Assumptions of Emerging Peanut Allergy Drugs and Market Outlook Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Peanut Allergy Market Access and Reimbursement Download the report to understand which factors are driving peanut allergy market trends @ Peanut Allergy Treatment Market Table of Contents 1 Key Insights 2 Report Introduction 3 Executive Summary 4 Key Events 5 Epidemiology and Market Forecast Methodology 6 Peanut Allergy Market Overview at a Glance 6.1 Market Share (%) Distribution by Therapies in 2024 in the 7MM 6.2 Market Share (%) Distribution by Therapies in 2034 in the 7MM 7 Disease Background and Overview 7.1 Introduction 7.2 Symptoms 7.3 Risk Factors 7.4 Pathophysiology of Peanut Allergy 7.5 Diagnosis 7.6 Treatment 8 Epidemiology and Patient Population 8.1 Key Findings 8.2 Assumptions and Rationale: 7MM 8.3 Total Diagnosed Prevalent Cases of Peanut Allergy in the 7MM 8.4 The United States 8.5 EU4 and the UK 8.6 Japan 9 Patient Journey 10 Marketed Drugs 10.1 Key Competitors 10.2 PALFORZIA (peanut allergen powder-dnfp): Stallergenes Greer 10.3 XOLAIR (omalizumab): Roche and Novartis 11 Emerging Therapies 11.1 Key Cross Competition 11.2 Viaskin (DBV712) peanut patch: DBV Technologies 11.3 Remibrutinib (LOU064): Novartis 11.4 PVX108 (AVX-201): Aravax 11.5 Sublingual Immunotherapy (SLIT)-Tablet: ALK-Abello 12 Peanut Allergy: Seven Major Market Analysis 12.2 Market Outlook 12.3 Conjoint Analysis 12.4 Key Market Forecast Assumptions 12.5 DBV Technology: In-depth Analysis 12.6 Total Market Size of Peanut Allergy by Country in the 7MM 12.7 United States Market Size 12.8 EU4 and the UK Market Size 12.9 Japan Market Size 13 Unmet Needs 14 SWOT Analysis 15 KOL Views 16 Market Access and Reimbursement 16.1 United States 16.2 EU4 and the UK 16.3 Japan 16.4 Market Access and Reimbursement of Peanut Allergy 17 Bibliography 18 Report Methodology Related Reports Food Allergy Market Food Allergy Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key food allergy companies including Stallergenes Greer, Roche, Novartis, ARS Pharmaceuticals, ALK-Abelló, Alfresa Pharma, DBV Technologies, Aquestive Therapeutics, Bryn Pharma, Aravax, RAPT Therapeutics, Allergy Therapeutics, Regeneron Pharmaceuticals, among others. Peanut Allergy Pipeline Peanut Allergy Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key peanut allergy companies, including Allergy Therapeutics, DBV Technologies, Novartis, Aravax, ALK-Abello, Intrommune Therapeutics, LAPIX Therapeutics, among others. Food Allergy Pipeline Food Allergy Pipeline Insight – 2025 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key food allergy companies, including DBV Technologies, Aravax, Xencor, Novartis AG, Vedanta Biosciences, Alladapt Immunotherapeutics, Intrommune Therapeutics, IgGenix, Lapix Therapeutics, Neovacs, Inimmune, among others. Lactose Intolerance Market Lactose Intolerance Market Insights, Epidemiology, and Market Forecast – 2034 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key lactose intolerance companies including CRitter Pharmaceuticals Inc., a2 Milk Company Ltd, VenterPharma, Eurofarma Laboratorios S.A, among others. About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve. Contact UsShruti Thakurinfo@ + Logo: View original content: SOURCE DelveInsight Business Research, LLP
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25-06-2025
- Health
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DBV Technologies Announces First Subject Screened in COMFORT Toddlers Supplemental Safety Study in Peanut Allergic Toddlers 1
Châtillon, France, June 25, 2025 DBV Technologies Announces First Subject Screened in COMFORT Toddlers Supplemental Safety Study in Peanut Allergic Toddlers 1 – 3 Years Old First subject screened at the Respiratory Medicine Research Institute of Michigan with Dr. Jeffrey Leflein acting as Principal Investigator Additional sites, including Allergy and Asthma Center of Minnesota and Hamilton Allergy and Immunology Clinic of Ontario, Canada have been activated and are scheduling screenings DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Market: DBVT), a clinical-stage biopharmaceutical company, today provided an update on the progress on the Company's COMFORT Toddlers supplemental safety study using the Viaskin® Peanut patch 250 μg in peanut-allergic children ages 1 – 3 years old. COMFORT Toddlers will enroll approximately 480 subjects at approximately 80 – 90 study centers across the U.S., Canada, Australia, UK and Europe. Principal Investigator, Jeffrey Leflein, MD, FAAAAI, FACAAI from the Respiratory Medicine Research Institute of Michigan, in Ann Arbor, Michigan screened the first subject in the study. Additionally, Dr. Doug McMahon, MD, Allergy and Asthma Center in Maplewood, Minnesota and Dr. Jason Ohayon, MD, Hamilton Allergy and Immunology Clinic in Ontario, Canada have been activated and are currently open to recruitment. "I am thrilled that our talented team of clinicians was the first to screen a subject for the COMFORT Toddlers supplemental safety study and we have several other potential subjects scheduled for screening,' said Dr. Leflein. 'The initiation of subject enrollment in COMFORT Toddlers reinforces our commitment to peanut-allergic children and their families and is an important step in generating the data needed to potentially advance the Viaskin Peanut patch to market.' COMFORT Toddlers is a Phase 3 double-blind, placebo-controlled (DBPC) safety study designed to supplement the safety and efficacy data from the completed Phase 3 EPITOPE study in the same population. The study duration will be six months followed by an optional 18-month open-label treatment phase, to generate up to 24 or 18 months of active treatment with the Viaskin Peanut patch for participants randomized to the active or placebo groups, respectively. 'I am very pleased subject screening has commenced in COMFORT Toddlers and look forward to working with my fellow investigators on the efficient enrollment and execution of this important study,' stated Julie Wang, MD, FAAAAI, FACAAI, Professor of Pediatrics, Jaffe Food Allergy Institute, the Icahn School of Medicine at Mount Sinai and Global Principal Investigator for the COMFORT Toddlers study 'The interest we've seen to date further reinforces the significant unmet need that exists for this specific subject cohort.' 'Screening our first subject marks a crucial step forward in our mission to develop this potential groundbreaking therapy for food allergic patients, as we are now well underway with both of our core clinical programs,' said Daniel Tassé CEO, DBV Technologies. 'We believe the data generated through the COMFORT Toddlers study will complete the data set necessary for a Biologics License Application submission to the FDA. DBV is committed to advancing the development of Viaskin Peanut. Our patients and their families are counting on us.' The data generated from COMFORT Toddlers will support the submission of a BLA anticipated in 2H 2026 under the Accelerated Approval Pathway, as previously agreed to with FDA. Investor Conference Call and Webcast DBV management will host an investor conference call and webcast today, Wednesday, June 25th, at 5:00pm EDT, to discuss these updates. This call is accessible via the teleconferencing numbers below and requesting the DBV Technologies call. United States: +1-877-346-6112 International: +1-848-280-6350 A live webcast of the call will be available on the Investors & Media section of the Company's website: A replay of the presentation will also be available on DBV's website after the event. About DBV TechnologiesDBV Technologies is a clinical-stage biopharmaceutical company developing treatment options for food allergies and other immunologic conditions with significant unmet medical need. DBV is currently focused on investigating the use of its proprietary VIASKIN® patch technology to address food allergies, which are caused by a hypersensitive immune reaction and characterized by a range of symptoms varying in severity from mild to life-threatening anaphylaxis. Millions of people live with food allergies, including young children. Through epicutaneous immunotherapy (EPIT™), the VIASKIN® patch is designed to introduce microgram amounts of a biologically active compound to the immune system through intact skin. EPIT is a new class of non-invasive treatment that seeks to modify an individual's underlying allergy by re-educating the immune system to become desensitized to allergen by leveraging the skin's immune tolerizing properties. DBV is committed to transforming the care of food allergic people. The Company's food allergy programs include ongoing clinical trials of VIASKIN Peanut in peanut allergic toddlers (1 through 3 years of age) and children (4 through 7 years of age). DBV Technologies is headquartered in Châtillon, France, with North American operations in Warren, NJ. The Company's ordinary shares are traded on segment B of Euronext Paris (Ticker: DBV, ISIN code: FR0010417345) and the Company's ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Market (Ticker: DBVT; CUSIP: 23306J309). For more information, please visit and engage with us on X (formerly Twitter) and LinkedIn. Forward Looking StatementsThis press release may contain forward-looking statements and estimates, including statements regarding the therapeutic potential of Viaskin® Peanut patch and EPIT™, designs of DBV's anticipated clinical trials, DBV's planned regulatory and clinical efforts including timing and results of communications with regulatory agencies, and the ability of any of DBV's product candidates, if approved, to improve the lives of patients with food allergies. These forward-looking statements and estimates are not promises or guarantees and involve substantial risks and uncertainties. At this stage, DBV's product candidates have not been authorized for sale in any country. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with research and development, clinical trials and related regulatory reviews and approvals, and DBV's ability to successfully execute on its budget discipline measures. A further list and description of risks and uncertainties that could cause actual results to differ materially from those set forth in the forward-looking statements in this press release can be found in DBV's regulatory filings with the French Autorité des Marchés Financiers ('AMF'), DBV's filings and reports with the U.S. Securities and Exchange Commission ('SEC'), including in DBV's Annual Report on Form 10-Q for the year ended March 31, 2025, filed with the SEC on April 30, 2025, and future filings and reports made with the AMF and SEC by DBV. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, DBV Technologies undertakes no obligation to update or revise the information contained in this Press Release. Viaskin is a registered trademark and EPIT is a trademark of DBV Technologies. Investor Contact Katie MatthewsDBV Media ContactBrett WhelanDBV Attachment PDF VersionError in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
