DBV Technologies Announces Positive Topline Results from Phase 3 VITESSE Trial of VIASKIN® Peanut Patch in Peanut Allergic Children Aged 4-7 Years

Rhea-AI Summary

DBV Technologies (Nasdaq:DBVT) announced positive topline Phase 3 VITESSE results for the VIASKIN Peanut patch in children aged 4–7. The trial met its primary endpoint: 46.6% responder rate on active vs 14.8% on placebo (difference 31.8%; 95% CI 24.5–39.0%; lower bound >15%; p=1x10-17). VITESSE enrolled 654 children (438 active, 216 placebo). Safety was consistent with prior studies: no treatment-related serious adverse events, 0.5% treatment-related anaphylaxis (n=2), discontinuations 3.2% active vs 0.5% placebo, and compliance 96.2%. A U.S. BLA submission in H1 2026 is on track. Positive topline results accelerate exercise of warrants, now exercisable through Jan 15, 2026.

Positive

• Primary endpoint met with 31.8% absolute response difference
• Statistically robust result: p=1x10-17 and 95% CI lower bound 24.5%
• Enrollment exceeded target at 654 children
• BLA submission for 4–7-year-olds on track in H1 2026
• No treatment-related serious adverse events reported

Negative

• Discontinuations higher on treatment: 3.2% vs 0.5% placebo
• Treatment-related anaphylaxis occurred in 0.5% of patients (n=2)
• Potential dilution from warrants exercisable up to €168.2M

Key Figures

Responder rate (active) 46.6% Children on VIASKIN Peanut meeting responder criteria at 12 months in VITESSE

Responder rate (placebo) 14.8% Children in placebo arm meeting responder criteria at 12 months in VITESSE

Difference in response 31.8% (95% CI 24.5–39.0%) Treatment effect size for VITESSE primary endpoint; lower CI bound exceeded 15% threshold

P-value p=1x10-17 Statistical significance of treatment effect in VITESSE primary endpoint

Trial enrollment 654 children (438 active / 216 placebo) Randomized participants in VITESSE Phase 3 peanut-allergic ages 4–7

Discontinuations (TEAEs) 3.2% active vs 0.5% placebo Discontinuations due to treatment-emergent adverse events in VITESSE

Treatment-related anaphylaxis 0.5% (n=2) Treatment-related anaphylaxis rate in VITESSE; both children continued treatment

March 2025 financing size up to €284.5 million Financing including €116.3M upfront and up to €168.2M via ABSA and BS warrants

Market Reality Check

$17.98 Last Close

Volume Volume 370,611 is 0.79x the 20-day average of 470,097, showing no pre-news accumulation signal. normal

Technical Shares at $18.29 trade above the $10.25 200-day MA and sit 14.93% below the $21.50 52-week high.

Peers on Argus

DBVT was down 0.44% pre-release, while peers showed mixed moves: CADL -10.12%, OMER -9.8%, ANNX -1.6%, CAPR +2.63%, NGNE -3.75%, pointing to stock-specific rather than broad-sector dynamics.

Common Catalyst Select biotech peers, such as CAPR, also reported clinical trial milestones, highlighting ongoing trial newsflow in the space.

Historical Context

Date	Event	Sentiment	Move	Catalyst
Dec 02	Capital structure update	Neutral	-0.6%	Routine disclosure of total shares and voting rights as of Nov 30, 2025.
Nov 11	Clinical trial progress	Positive	-1.8%	Completion of last patient visit in VITESSE Phase 3 ahead of topline data.
Nov 04	Conference participation	Neutral	+0.8%	CEO fireside chat at Guggenheim Healthcare Innovation Conference.
Nov 03	Management appointment	Positive	-2.7%	Appointment of Chief Commercial Officer to lead Viaskin Peanut strategy.
Nov 03	Capital structure update	Neutral	-2.7%	Disclosure of total shares and voting rights as of Oct 31, 2025.

Pattern Detected

Recent positive corporate and clinical milestones have often coincided with modest or negative next-day price moves, indicating a tendency for divergence on good news.

Recent Company History

Over the last few months, DBV has focused on advancing the VIASKIN Peanut program and strengthening its platform. Clinical operations progressed from VITESSE patient visits to readiness for topline data in Q4 2025, with a planned BLA for ages 4–7 in H1 2026. Corporate updates included appointing a Chief Commercial Officer to prepare commercialization and routine disclosures of voting rights and share counts. Against that backdrop, today’s positive VITESSE Phase 3 topline readout represents the key efficacy milestone previously flagged in earlier updates.

Market Pulse Summary

The stock is surging +55.2% following this news. A strong positive reaction aligns with the clearly favorable VITESSE data, including a 46.6% responder rate versus 14.8% on placebo and a highly significant p=1x10-17. Past clinical updates have produced mixed price responses, so sustained gains could depend on how investors weigh the BLA timing and financing structure, including warrant exercises. Low sector-wide momentum suggests moves may remain company-specific rather than driven by broader biotech flows.

Key Terms

phase 3 medical

"its pivotal Phase 3 study assessing the safety and efficacy of VIASKIN"

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

biologics license application (bla) regulatory

"DBV is moving forward with plans for a Biologics License Application (BLA) submission"

A biologics license application (BLA) is a formal request to a government agency seeking approval to sell a biological medicine, such as vaccines or gene therapies, in the market. It is similar to a detailed report that proves the product is safe, effective, and manufactured properly. For investors, a BLA signifies a critical step toward commercial availability, often impacting a company's valuation and market prospects.

treatment-emergent adverse events (teaes) medical

"The most common treatment-emergent adverse events (TEAEs) observed during the VITESSE study"

Adverse events that first appear or worsen after a patient starts a medical treatment; they are the new or intensified negative effects linked in time to taking the drug or therapy. Investors care because the number and severity of these events shape regulators’ decisions, drug labeling, patient uptake and potential legal or cost risks—think of them like customer complaints that can slow sales, trigger recalls, or change a product’s value.

warrants financial

"exercise period of certain warrants issued pursuant to DBV’s March 2025 financing"

Warrants are special documents that give you the right to buy a company's stock at a set price before a certain date. They are often used as a way for companies to attract investors or raise money, and their value can increase if the company's stock price goes up.

placebo-controlled medical

"The double-blind, placebo-controlled treatment phase is complete"

"Placebo-controlled" describes a testing method where one group receives the actual treatment or intervention, while another group receives a harmless, inactive version called a placebo. This approach helps determine whether the real treatment has genuine effects beyond psychological expectations. For investors, understanding this ensures confidence that reported benefits are real and not influenced by bias or false perceptions.

breakthrough therapy designation regulatory

"The FDA previously granted Breakthrough Therapy Designation for VIASKIN Peanut patch"

A breakthrough therapy designation is a regulatory fast-track given to a drug or treatment that shows early signs of providing a major improvement over existing options for a serious condition. Think of it as a VIP lane that can speed up development and more intensive guidance from regulators, which matters to investors because it can shorten time to market, reduce development risk and potentially increase a company’s value — though it does not guarantee approval.

AI-generated analysis. Not financial advice.

Châtillon, France, December 16, 2025

DBV Technologies Announces Positive Topline Results from Phase 3 VITESSE Trial of VIASKIN® Peanut Patch in Peanut Allergic Children Aged 4-7 Years

• VITESSE met its primary endpoint: the lower bound of the 95% confidence interval (CI) of the difference between treatment arms was 24.5%, exceeding the prespecified threshold of 15% 
• 46.6% of children treated with the VIASKIN^® Peanut patch met response criteria at 12 months, compared to 14.8% of children in the placebo arm 
• Safety results were consistent with the safety profile observed in the VIASKIN Peanut clinical program to date
• BLA submission in 4-7-year-olds on track for the first half of 2026
• Achievement of primary endpoint triggers an acceleration of the exercise period of certain warrants issued pursuant to DBV’s March 2025 financing
• DBV to host a conference call today at 5:00 p.m. ET to discuss the VITESSE topline results and path forward

DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT – CUSIP: 23306J309), a late-stage biopharmaceutical company, today announced that VITESSE, its pivotal Phase 3 study assessing the safety and efficacy of VIASKIN^® Peanut patch for the treatment of peanut-allergic children aged 4 to 7 years, met its primary endpoint.

VIASKIN Peanut demonstrated a statistically significant treatment effect (p<0.001)*, with 46.6% of children in the VIASKIN Peanut arm meeting the treatment responder criteria after 12 months, as compared to 14.8% of children in the placebo arm (difference in response rates = 31.8%; 95% CI = (24.5, 39.0%)), exceeding the lower bound prespecified threshold of 15%.

Responders were defined as children with a baseline eliciting dose (ED) ≤30 mg who achieved an ED ≥300 mg of peanut protein at month 12, or a child with a baseline ED = 100 mg who achieved an ED ≥600 mg of peanut protein at month 12, as measured by a double-blind, placebo-controlled food challenge (DBPCFC). The ED is the amount of peanut protein that induced an allergic reaction. The month 12 responder rates for each ED sub-group performed as expected based on the Company’s statistical projections.

“Peanut allergy places a considerable burden on children and their families that is insufficiently addressed by current treatment options or strict avoidance,” stated David Fleischer M.D., Professor of Pediatrics at Children's Hospital Colorado and Global Principal Investigator of the VITESSE study. “I’m thrilled by these topline results which show a statistically significant treatment effect in children treated with the VIASKIN Peanut patch. The levels of desensitization achieved in this study after one year on treatment are highly clinically meaningful and represent substantial progress towards a well-tolerated, non-invasive potential option that I believe would be welcomed into pediatric care. As a practicing allergist, I look forward to what that may mean for families managing peanut allergy every day and hope to be able to implement this treatment in my clinic, if approved.”

VITESSE enrolled 654 children, exceeding its original enrollment target of 600, of which 438 and 216 were randomized to the active and placebo arms, respectively. Enrollment was balanced for age and baseline disease characteristics between the active and placebo treatment arms. Rates of enrollment in the VITESSE open-label extension were in line with previous VIASKIN Phase 3 studies.

Safety results were consistent with the safety profile of the VIASKIN Peanut clinical program to date. The most common treatment-emergent adverse events (TEAEs) observed during the VITESSE study were mild-to-moderate local skin reactions at the patch application site. Discontinuations due to TEAEs were low at 3.2% in the treatment arm compared to 0.5% of in the placebo arm. Notably, there were no reports of treatment-related serious adverse events and treatment-related anaphylaxis was low at 0.5% (n=2) – both children continued treatment. The data from the exploratory adhesion assessments were in line with the Company's expectations. Overall, compliance was high at 96.2%, consistent with what has been observed in other Phase 3 VIASKIN Peanut studies.

“We saw tremendous enthusiasm around EPIT and the VIASKIN Peanut patch development program at ACAAI’s annual scientific meeting last month” said allergist Cherie Zachary M.D., President of the American College of Allergy, Asthma and Immunology. “I am excited to see what’s possible with this innovative treatment in 4-7-year-old patients, if approved. I look forward to open-label results in the future to fully understand the potential impact VIASKIN Peanut can have in this age group.”

DBV is moving forward with plans for a Biologics License Application (BLA) submission in the United States in the first half of 2026.

“VITESSE is the largest immunotherapy clinical trial ever conducted in food allergy and we are thrilled that the resulting clinical evidence supporting the VIASKIN Peanut patch is robust. With these data in hand, I am looking forward to submitting the BLA to the FDA, as planned, in the first half of 2026,” stated Daniel Tassé, Chief Executive Officer of DBV Technologies. “I would again like to express my gratitude to the FDA for a constructive dialogue that enabled us to reach alignment on a path forward for this important program, as well as our clinical investigators and their staff. Most importantly, we must acknowledge the tremendous belief, dedication, and investment made by patients and all those who participated in the study—without whom the efficient execution of the study would not have been possible. Thanks to the food allergy community, we are one step closer to delivering on our mission to transform the lives of children and families living with peanut allergy.”

The FDA previously granted Breakthrough Therapy Designation for VIASKIN Peanut patch, and the Company expects the BLA may be eligible for priority review.

Investor Conference Call and Webcast 
DBV management will host an investor conference call and webcast today, Tuesday, December 16th, at 5:00pm ET, to discuss the VITESSE results and next steps for the program. 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: https://www.dbv-technologies.com/investor-relations/. A replay of the presentation will also be available on DBV’s website after the event.

Business Updates
These positive results represent a major milestone for DBV Technologies. In connection with this announcement and the notice to investors posted to the Company’s website, in March 2025 DBV announced a financing of up to €284.5 million, including gross proceeds of €116.3 million received upon closing and an aggregate of up to €168.2 million in gross proceeds subject to the full exercise of the warrants attached to the new ordinary shares (the “ABSA Warrants”) and the warrants attached to the first pre-funded warrants (the “BS Warrants”) issued by the Company on April 7, 2025. The terms of the financing provided that the exercise period of the ABSA Warrants and BS Warrants is accelerated upon the announcement of positive VITESSE topline results. As a result of this announcement of positive VITESSE topline results, the ABSA Warrants and BS Warrants are exercisable through January 15, 2026, which is 30 days following the publication of this announcement (the “Exercise Period”). The Company will publish a comprehensive press release following the end of the Exercise Period (or following the date on which all ABSA Warrants and BS Warrants have been exercised, as the case may be).

*p=1x10^-17

About DBV Technologies
DBV Technologies is a late-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. 

About the VITESSE Study
VITESSE (NCT05741476) is a global Phase 3, randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of the VIASKIN Peanut patch 250 µg in children ages 4-7 years with peanut allergy. The study enrolled 654 children randomized 2:1 to receive either VIASKIN Peanut patch or placebo. Conducted at 86 sites across the United States, Canada, United Kingdom, Europe, and Australia, VITESSE represents the largest immunotherapy clinical trial for this patient population. The primary endpoint is the difference between the percentage of treatment responders in the active versus placebo group after 12 months of treatment. Following the 12-month double-blind period, children were given the option to continue into an open-label extension where all participants receive VIASKIN Peanut patch for up to a total of three years on treatment.

DBV plans to present the full VITESSE results at future medical congresses as well as submit them for publication in a peer-reviewed journal. 

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, results of DBV’s 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, expectations around the BLA’s potential for priority review,  the exercisability of warrants issued in connection with the financing announced on March 27, 2025, 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, filed with the SEC on October 28, 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 of DBV Technologies. 

Investor Contact
Jonathan Neely
DBV Technologies
jonathan.neely@dbv-technologies.com

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

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FAQ

What were the VITESSE topline responder rates for DBVT's VIASKIN Peanut in children 4–7?

Responder rates were 46.6% for VIASKIN Peanut vs 14.8% for placebo at 12 months.

Did DBV meet the VITESSE primary endpoint and how significant was it for DBVT?

Yes; the difference was 31.8% with 95% CI 24.5–39.0% and p=1x10-17, exceeding the prespecified 15% threshold.

When will DBV file a BLA to the FDA for VIASKIN Peanut (DBVT)?

DBV expects to submit the U.S. BLA in the first half of 2026.

How many patients were enrolled in VITESSE and how were they randomized for DBVT?

VITESSE enrolled 654 children, randomized 438 to active and 216 to placebo.

What safety signals did DBV report from VITESSE for VIASKIN Peanut?

No treatment-related serious adverse events; local skin reactions were most common; treatment-related anaphylaxis was 0.5% (n=2).

How does the VITESSE result affect DBV's financing warrants exercise period (DBVT)?

Positive topline results accelerated exercise of ABSA and BS warrants, now exercisable through Jan 15, 2026, enabling up to €168.2M additional proceeds if exercised.