DBV Technologies Highlights Additional Data from Successful Phase 3 VITESSE Study at the AAAAI 2026 Annual Meeting

Rhea-AI Summary

DBV Technologies (Nasdaq:DBVT) reported additional positive data from the Phase 3 VITESSE study of the VIASKIN® Peanut Patch at AAAAI 2026. The trial met its primary endpoint: 46.6% responders on VIASKIN versus 14.8% on placebo (difference 31.8%, p<0.001).

Additional highlights: 82.8% increased eliciting dose by ≥1 step, 60.1% by ≥2 steps, low serious safety signals, and a planned Biologics License Application submission to FDA in H1 2026.

Positive

• Primary endpoint met: 46.6% responders vs 14.8% placebo (△=31.8%; p<0.001)
• 82.8% of treated children increased eliciting dose by ≥1 step at month 12
• 60.1% of treated children increased eliciting dose by ≥2 steps at month 12
• All sensitivity analyses remained statistically significant with 95% CI above prespecified 15% threshold
• Company plans to submit a BLA to FDA in H1 2026

Negative

• Less than half of treated children (53.4%) did not meet responder criteria at 12 months
• 6.4% of treated subjects experienced a decrease in eliciting dose versus baseline

Key Figures

Responder rate (active): 46.6% Responder rate (placebo): 14.8% Treatment effect difference: 31.8% (95% CI 24.5–39.0%) +5 more

8 metrics

Responder rate (active) 46.6% VITESSE primary endpoint at 12 months (VIASKIN Peanut arm)

Responder rate (placebo) 14.8% VITESSE primary endpoint at 12 months (placebo arm)

Treatment effect difference 31.8% (95% CI 24.5–39.0%) Difference in responder rates, primary endpoint

Statistical significance p<0.001 Primary endpoint for VITESSE Phase 3

≥1-dose increase (active) 82.8% Children increasing eliciting dose by ≥1 step at month 12

≥2-dose increase (active) 60.1% Children increasing eliciting dose by ≥2 steps at month 12

Placebo dose decrease 24% vs 6.4% Subjects with decreased eliciting dose, placebo vs VIASKIN

Responder subgroup (ED ≤30mg) 49.3% vs 14.7% Treatment vs placebo responders in low baseline ED stratum

Market Reality Check

Price: $20.99 Vol: Volume 372,481 is above i...

normal vol

$20.99 Last Close

Volume Volume 372,481 is above its 20-day average of 267,458 (relative volume 1.39). normal

Technical Shares at $20.99 are trading above the 200-day MA ($13.72), reflecting strength into this update.

Peers on Argus

Peers show mixed moves: ANNX and OMER were up (e.g., ANNX +5.46%), while CADL an...

2 Up 1 Down

Peers show mixed moves: ANNX and OMER were up (e.g., ANNX +5.46%), while CADL and NGNE declined (NGNE about -2.98%). This mixed action, alongside scanner activity with both up and down movers, points to stock-specific factors around DBVT rather than a clean sector-wide trend.

Previous Clinical trial Reports

5 past events · Latest: Feb 10 (Positive)

Same Type Pattern 5 events

Date	Event	Sentiment	Move	Catalyst
Feb 10	Data presentation plans	Positive	-5.0%	Planned AAAAI 2026 presentation of additional positive VITESSE Phase 3 data.
Dec 16	Topline Phase 3 data	Positive	+25.4%	Positive topline VITESSE Phase 3 results with strong responder difference.
Nov 11	Trial completion	Positive	+3.2%	Completion of last patient visit in VITESSE Phase 3 peanut patch trial.
Jan 08	Long-term efficacy data	Positive	+29.8%	Positive 3‑year EPITOPE extension results in toddlers on Viaskin Peanut.
Sep 23	Enrollment milestone	Positive	+4.3%	Completion of screening and exceeding recruitment goals for VITESSE trial.

Pattern Detected

Clinical trial news has typically been met with positive price reactions, with one notable negative reaction around an earlier VITESSE data-presentation headline.

Recent Company History

Over the past ~18 months, DBV has steadily advanced its VIASKIN Peanut program. It completed VITESSE screening with 600+ subjects and later reported positive Phase 3 topline data with clear efficacy in children aged 4–7. Subsequent milestones included last patient visit completion and strong 3‑year EPITOPE results in toddlers. A February 2026 AAAAI presentation of additional VITESSE data previously saw a -5.04% move, showing that rich clinical detail does not always align with short-term trading.

Historical Comparison

+11.5% avg move · Across recent clinical-trial headlines, DBVT moved an average of about 11.53%, showing that data and...

clinical trial

+11.5%

Average Historical Move clinical trial

Across recent clinical-trial headlines, DBVT moved an average of about 11.53%, showing that data and milestone updates have often been meaningful trading catalysts.

Clinical updates show a clear arc: early VITESSE screening completion, then last‑patient‑visit, followed by positive topline data and now detailed efficacy and responder analyses supporting a planned BLA.

Market Pulse Summary

This announcement adds detailed Phase 3 VITESSE data showing a 46.6% responder rate on VIASKIN Peanu...

Analysis

This announcement adds detailed Phase 3 VITESSE data showing a 46.6% responder rate on VIASKIN Peanut versus 14.8% on placebo and a 31.8% treatment-effect difference with p<0.001. Increases in eliciting dose and lower sensitization rates in treated children reinforce the clinical profile described in earlier topline results. Historically, DBVT’s clinical updates have often coincided with meaningful stock moves, so investors may watch how these data support the planned BLA and future regulatory milestones.

Key Terms

treatment emergent adverse events, confidence interval, phase 3, biologics license application

4 terms

treatment emergent adverse events medical

"The VIASKINae Peanut Patch was well tolerated; the majority of treatment emergent adverse events"

Treatment emergent adverse events are any new or worsened medical problems that appear after a patient starts a drug or medical intervention during a clinical trial. Investors care because the number, severity, and frequency of these events influence safety profiles, regulatory approval chances, and market acceptance; think of them like unexpected problems that crop up after installing a software update—minor ones may be manageable, but serious or common issues can stall or derail the product.

confidence interval technical

"difference in response rates = 31.8%; 95% confidence interval (CI) = (24.5, 39.0%)"

An interval estimate that shows a range of values within which a true number (like a company’s expected earnings, a projected return, or a model input) is likely to lie, together with a stated level of confidence in that range. For investors it turns a single point forecast into a band—like a weather forecast saying 60–70°F instead of just 65°F—making uncertainty explicit so you can judge risk and size positions more sensibly.

phase 3 medical

"VITESSE, the largest food allergy immunotherapy trial to date, is a Phase 3 study"

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 regulatory

"these data support a Biologics License Application, which we are planning to submit"

A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.

AI-generated analysis. Not financial advice.

Châtillon, France, February 28, 2026

DBV Technologies Highlights Additional Data from Successful Phase 3 VITESSE Study at the AAAAI 2026 Annual Meeting

• Approximately 83% of children treated with the VIASKIN^® Peanut Patch increased their eliciting dose at month 12, compared to approximately 48% in the placebo group
• Approximately 60% of children treated with the VIASKIN^® Peanut Patch increased their eliciting dose by at least two doses at month 12, compared to 23% in the placebo group
• 24% of children on placebo decreased their eliciting dose between the baseline and month 12 double-blind, placebo-controlled food challenge, compared to only 6.4% of children treated with the VIASKIN^® Peanut Patch
  
  

DBV Technologies (Euronext: DBV – ISIN: FR0010417345 – Nasdaq Stock Market: DBVT), a late-stage biopharmaceutical company, today announced that the company shared additional positive data from the successful Phase 3 VITESSE clinical trial as an oral presentation today at the American Academy of Allergy, Asthma, and Immunology (AAAAI) 2026 Annual Meeting, in Philadelphia, PA. VITESSE, the largest food allergy immunotherapy trial to date, is a Phase 3 study assessing DBV’s VIASKIN^® Peanut Patch for the treatment of peanut-allergic children aged 4 to 7 years.

The VITESSE study met its primary endpoint whereby 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* at 12 months, as compared to 14.8% of children in the placebo arm (difference in response rates = 31.8%; 95% confidence interval (CI) = (24.5, 39.0%)), exceeding the lower bound prespecified threshold of 15%.

Highlights from the data presented at AAAAI 2026:

• 82.8% of subjects treated with the VIASKIN^® Peanut Patch increased their eliciting dose by at least one dose, or one incremental step in a double-blind placebo-controlled food challenge, at month 12, compared to approximately 48% in the placebo group.
• 60.1% of the treated subjects increased their eliciting dose by at least two doses of the double-blind, placebo-controlled food challenge at month 12, compared to 23.4% in the placebo group.
• 24% of subjects on placebo decreased their eliciting dose between the baseline and month 12 double-blind, placebo-controlled food challenge, compared to only 6.4% of treated subjects.
• All sensitivity analyses were statistically significant with the 95% CI exceeding the lower bound prespecified threshold of 15%, ranging from 22.1% to 27.8%, confirming the robustness of the primary endpoint analysis.
• In both baseline eliciting dose (ED) strata, a significantly greater proportion of children treated with the VIASKIN^® Peanut Patch were treatment responders as compared to the placebo group.
  • Among children with a baseline ED ≤ 30mg, 49.3% were responders versus 14.7% in the placebo group (△=34.6%; 95% CI: 24.93, 44.24).
  • Among children with a baseline ED = 100mg, 43.1% were responders versus 14.6% in the placebo group (△=28.5%; 95% CI: 17.51, 39.5).
• The VIASKIN^® Peanut Patch was well tolerated; the majority of treatment emergent adverse events (TEAEs) were mild local application site reactions, consistent with DBV’s previous Phase 3 studies.
  

“Building on the statistically significant topline results from the VITESSE Phase 3 study, the additional data presented at this year’s AAAAI Annual Meeting suggest a broad and consistent treatment effect of the VIASKIN^® Peanut Patch, regardless of baseline eliciting dose strata or study population analysis,” stated David Fleischer M.D., Professor of Pediatrics at Children’s Hospital Colorado and Global Principal Investigator of the VITESSE study. “The increases in eliciting dose seen are clinically meaningful and may reflect a reduced risk of an allergic reaction. Conversely, nearly four times as many children on placebo saw their eliciting dose decrease, becoming more sensitized over the twelve-month period. These results not only support the VIASKIN^® Peanut Patch as a potential treatment option for peanut-allergic children, if approved, but also reinforce the importance of prioritizing a proactive treatment for this specific patient population."

“We believe the additional data presented today demonstrate that the VIASKIN^® Peanut Patch consistently induced desensitization among subjects irrespective of study subgroup or baseline characteristics,” stated Pharis Mohideen M.D., Chief Medical Officer of DBV Technologies. “If approved, the VIASKIN^® Peanut Patch would provide caregivers with a non-invasive option that fits into daily activities. To that end, these data support a Biologics License Application, which we are planning to submit to FDA in the first half of this year.”

The presentation will be made available on the Scientific Publication & Presentations page on the Company’s website at https://dbv-technologies.com/events/aaaai-annual-meeting-2026/.

*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 children 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.

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 Technologies 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 Technologies is committed to transforming the care of food allergic people. The Company’s food allergy programs include ongoing clinical trials of the VIASKIN^® Peanut Patch 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 (DBV, ISIN code: FR0010417345) and the Company’s ADSs (each representing five ordinary shares) are traded on the Nasdaq Capital Market (DBVT – CUSIP: 23306J309).

For more information, please visit www.dbv-technologies.com and engage with us on X (formerly Twitter) and LinkedIn.

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, 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.

The Company reminds that the going concern assessment is made as of the date of this press release based on management’s current assumptions. In accordance with U.S. GAAP, IFRS, SEC and AMF rules, the Company will update its going‑concern evaluation as of the issuance of its Annual Report on Form 10‑K and the universal registration document.

VIASKIN is a registered trademark of DBV Technologies.

Investor Relations 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 Phase 3 primary results for DBV Technologies (DBVT) presented at AAAAI 2026?

The trial met its primary endpoint: 46.6% responders with VIASKIN versus 14.8% placebo (31.8% difference; p<0.001). According to the company, this exceeded the prespecified lower bound threshold of 15% and was statistically significant.

How many children on VIASKIN Peanut increased their eliciting dose at month 12 in the VITESSE study?

82.8% of treated children increased their eliciting dose by at least one step at month 12. According to the company, 60.1% increased by at least two steps versus 23.4% for placebo.

What safety profile did DBV report for the VIASKIN Peanut Patch in VITESSE (DBVT)?

The VIASKIN Peanut Patch was reported as well tolerated, with most treatment-emergent adverse events being mild local application-site reactions. According to the company, safety was consistent with prior Phase 3 studies.

Did VITESSE show consistent efficacy across baseline eliciting dose subgroups for DBVT?

Yes. Both baseline ED strata showed significant treatment effects: 49.3% responders (ED ≤30mg) and 43.1% responders (ED=100mg). According to the company, both exceeded placebo response rates significantly.

Will DBV Technologies (DBVT) seek FDA approval for the VIASKIN Peanut Patch and when?

Yes, the company plans to submit a Biologics License Application in the first half of 2026. According to the company, the VITESSE data support that planned BLA submission timeline.

What does a VITESSE responder mean for a child in the DBVT trial?

Responders had baseline ED ≤30mg reaching ≥300mg or baseline ED=100mg reaching ≥600mg of peanut protein at month 12. According to the company, ED was measured by double-blind, placebo-controlled food challenge.