DBV Technologies to Participate in Upcoming ACAAI 2025 Annual Scientific Meeting

Rhea-AI Summary

DBV Technologies (Nasdaq: DBVT) will participate in the ACAAI 2025 Annual Scientific Meeting in Orlando, November 6–10, 2025. DBV will host a Product Theater on Nov 8, 2025 (11:35 a.m.–1:00 p.m. ET) titled “Harnessing Immune Plasticity to Alter the Path of Food Allergy.”

The presentation will include a panel of allergists and details of a planned Phase 2 study assessing VIASKIN Peanut patch efficacy and safety to achieve ad lib peanut consumption in infants aged 6–12 months after a minimum of 3 years of treatment. Dr. Matthew Greenhawt will present EPOPEX end-of-study results on Nov 8 at 4:43 p.m. ET.

DBV will exhibit at booth #711, sponsor the FIT Bowl on Nov 8 (5:45–7:45 p.m. ET), and notes line-of-sight to a potential BLA filing for toddlers 1–3 years in the second half of next year under an Accelerated Approval Pathway.

Insights

Clinical Development Strategist

DBV announces a Phase 2 study in infants and signals a potential BLA filing for toddlers; clinical and regulatory milestones now the key catalysts.

DBV will present a planned Phase 2 study testing the VIASKIN® Peanut patch in peanut-allergic infants aged 6 through 12 months, with assessment of ad lib peanut consumption after a minimum of 3 years of treatment. The company also cites end-of-study results from the three-year EPOPEX open-label extension and notes line-of-sight to a potential BLA filing for toddlers ages 1–3 years in the second half of next year under an Accelerated Approval pathway previously agreed with the FDA.

The business mechanism is straightforward: advancing earlier-age immunotherapy could expand the indicated population and support regulatory filings if efficacy and safety are adequate. Key dependencies include the Phase 2 study design, successful enrollment and multi-year treatment adherence, and confirmatory safety/efficacy data from long-term follow-up such as EPOPEX. Risks are inherent: multi-year pediatric studies require retention and clear endpoints to satisfy accelerated pathways.

Concrete items to watch are initiation and enrollment milestones for the Phase 2 infant study, interim or final efficacy/safety readouts tied to the stated 3-year treatment duration, and the timing and content of the potential BLA submission in the second half of next year. These milestones will determine near-term regulatory and commercial relevance.

Châtillon, France, October 30, 2025

DBV Technologies to Participate in Upcoming ACAAI 2025 Annual Scientific Meeting

DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT – CUSIP: 23306J309), a clinical-stage biopharmaceutical company, today announced upcoming participation in the American College of Allergy, Asthma & Immunology (ACAAI) 2025 Annual Scientific Meeting, November 6 - 10, in Orlando, Florida.

DBV will host a Product Theater titled “Harnessing Immune Plasticity to Alter the Path of Food Allergy”. A panel of renowned allergists, Drs. Gideon Lack, Hugh Sampson, George du Toit, Kirsten Perrett and Matthew Greenhawt, will discuss immunological and clinical evidence in support of the benefits of earlier intervention in food allergy management. During the presentation, Dr. Perrett will present details of a planned Phase 2 clinical study in which DBV will assess the efficacy and safety of the VIASKIN^® Peanut patch in achieving ad lib consumption of dietary peanut in peanut-allergic infants 6 through 12 months of age following a minimum of 3 years of treatment.

Product Theater Details:

• Date: Saturday, November 8, 2025
• Time: 11:35 a.m. to 1:00 p.m. ET
• Location: West Hall E
  
  

“We’re beginning to see a shift towards a more proactive approach to food allergy management, both when it comes to early introduction of potential allergens and the use of immunomodulatory interventions,” stated Dr. Gideon Lack, Professor of Pediatric Allergy, London Allergy Care and Knowledge and co-principal investigator of the Phase 2 early intervention clinical study. “With this upcoming study, we now have an opportunity to investigate if earlier intervention with the VIASKIN^® Peanut patch, a potentially disease-modifying immunotherapy, can help achieve ad lib peanut consumption in children aged 6 to 12 months.”

This year’s meeting will also feature a presentation by Dr. Matthew Greenhawt on the end-of-study results from the open-label extension to the EPITOPE study (EPOPEX) as part of the “Distinguished Industry and Late-breaking Oral Abstract” session.

“With our product theater announcing a first-of-its-kind phase 2 study to assess if the VIASKIN® Peanut patch can achieve ad lib consumption, and compelling end-of-study results from the three-year EPOPEX study, our well-rounded presence at this year’s meeting is representative of our work and commitment to the younger patient population within the food allergy community,” said Dr. Pharis Mohideen, Chief Medical Officer of DBV Technologies. “In addition to DBV’s highlighted clinical efforts in this younger patient population, we have line-of-sight to a potential BLA filing for VIASKIN® Peanut patch for toddlers ages 1 – 3 years in the second half of next year under an Accelerated Approval Pathway as previously agreed upon with the FDA.”

Oral Scientific Presentation Details:

• “Long-Term Efficacy and Safety of Epicutaneous Immunotherapy in Peanut-Allergic Toddlers: EPOPEX End-of-Study Results” will be presented by Dr. Matthew Greenhawt
• Session: Distinguished Industry & Late-breaking Oral Abstracts - Session 2
• Date: Saturday, November 8, 2025
• Session time: 4:30 to 6:00 p.m. ET
• Presentation time: 4:43 p.m. ET
• Location: Room W231

The Company will exhibit at booth #711 and is sponsoring the 34th Annual FIT Bowl™, a game show-type competition that tests allergy, asthma, and immunology knowledge of participating teams from training programs around the country. The competition is set to be held on Saturday, November 8th, from 5:45 p.m. to 7:45 p.m. ET.

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 www.dbv-technologies.com and engage with us on X (formerly Twitter) and LinkedIn.

VIASKIN is a registered trademark of DBV Technologies.

Forward Looking Statements
This 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, plans and expectations with respect to the submission of BLAs to FDA, anticipated support for the BLA submission, 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-K for the year ended December 31, 2024, filed with the SEC on April 11, 2025, as amended by Amendment No. 1 on Form 10-K/A filed with the SEC on April 28, 2025, and as amended further by Amendment No. 2 on Form 10-K/A filed with the SEC on May 14, 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.

Investor Contact
Katie Matthews
DBV Technologies
katie.matthews@dbv-technologies.com

Media Contact
Brett Whelan
DBV Technologies
brett.whelan@dbv-technologies.com

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FAQ

When will DBV Technologies (DBVT) present at ACAAI 2025 and what is the Product Theater topic?

DBV will host a Product Theater on Nov 8, 2025 from 11:35 a.m.–1:00 p.m. ET titled “Harnessing Immune Plasticity to Alter the Path of Food Allergy.”

What Phase 2 study will DBV (DBVT) discuss at ACAAI 2025 for VIASKIN Peanut?

DBV will present details of a planned Phase 2 study assessing VIASKIN Peanut patch in infants 6–12 months to evaluate ad lib peanut consumption after at least 3 years of treatment.

When and where will DBV present the EPOPEX end-of-study results at ACAAI 2025?

Dr. Matthew Greenhawt will present EPOPEX end-of-study results on Nov 8, 2025 at 4:43 p.m. ET in Room W231 during the Distinguished Industry & Late-breaking Oral Abstracts session.

Is DBV (DBVT) planning a BLA filing for VIASKIN Peanut and what is the timing?

DBV indicates line-of-sight to a potential BLA filing for VIASKIN Peanut for toddlers aged 1–3 years in the second half of next year under an Accelerated Approval Pathway.

Where can attendees find DBV at ACAAI 2025 and what events is the company sponsoring?

DBV will exhibit at booth #711 and is sponsoring the 34th Annual FIT Bowl, scheduled for Nov 8, 5:45–7:45 p.m. ET.

Who are some panelists featured in DBV’s Product Theater at ACAAI 2025?

Featured panelists include Drs. Gideon Lack, Hugh Sampson, George du Toit, Kirsten Perrett, and Matthew Greenhawt.